Patient-Centric, Smart Quality Controls for Immunoassays

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Patient-Centric, Smart Quality Controls for Immunoassays

In 2022, an updated version of ISO15189 was released, placing an emphasis on risk management with the aim of mitigating risk to patients. This updated document means that rigorous quality control (QC) procedures are more important than ever.

ISO15189:2022 cites the use of third-party controls with commutable matrices manufactured to provide concentrations close to clinical decision limits, among others, as crucial considerations. ISO15189:2022 also highlights the importance of identifying and minimising errors in the pre-analytical process. ‘Load & Go’ or ‘Smart’ quality controls are becoming increasingly popular in laboratories around the world to realise this objective.

Smart controls are designed to optimise laboratory workflows, allowing laboratorians to load the control onto an instrument where it can remain until its expiry date, bringing several advantages to laboratories who run immunoassays.

The first is the minimisation of human error and other pre-analytical errors. As these controls are ready-to-go out of the box, there is no chance of reconstitution errors which can result in deviations from target values and contamination which could lead to problematic cross-reactions. Smart quality controls reduce the risk of stability issues resulting from aliquoting or the repetitive opening of vials, and eliminate the possibility of mislabelled controls, while freeing up more storage space.

Smart controls also offer the possibility of improvements in other areas of the laboratory. The reduction in the preparation required for these controls allows laboratories to use this time improving other elements of their QC practices, such as QC analysis and process improvement. Less steps in the QC process not only means time saved in the process itself, but less paperwork for laboratory staff, further freeing up time for more useful practices.

Immunoassay Smart quality controls provide laboratories with an effective QC solution which aids in the optimisation of workflows and the reduction of test turnaround times and the risk of human error throughout the QC process. However, if considering a Smart quality controls for your laboratory, its important to remember the other factors which make a good QC including matrix, stability, and clinically relevant concentrations.

The New Acusera Smart range has been designed to streamline workflows, minimise human error and reduce the strain on your cold storage. The convenient design means these controls can be loaded directly onto the analyser allowing the automation of the QC process, reducing turnaround times and increasing efficiency.

As well as the Immunoassay control, the Acusera Smart range also includes Clinical Chemistry, Liquid Cardiac and Parathyroid Hormone controls. We offer two options: Acusera SmartScan and Acusera SmartLoad. Take a look at the graphic below for more details.

Acusera Smart Quality Controls - How it works

We will be adding more controls to our Smart range soon. To stay up to date with this and all our other product releases, join our mailing list. 

If you’d like some more information on any of the products in the Acusera range, don’t hesitate to get in touch. You can contact us at marketing@randox.com.


A Peculiar Problem in Pregnancy and the Placenta

Complications and Diagnosis of Pre-eclampsia

When we consider our most important organ its intuitive to choose the heart, the lungs or even the kidneys. However, there’s another without which none of us would be here to have the discussion. This ephemeral organ provides us with the nutrients necessary for development, removes malevolent agents, provides our initial immunity and much more, before being cast off as we enter the world. We are, of course, talking about the placenta. Indeed, all our organs work together to support life and it’s arbitrary to imbue one with more importance than the others. Nevertheless, as our first organ, the significance of the placenta is irrefutable.

Placental dysfunction, along with several other factors, is known to contribute to the development of pre-eclampsia – a complex, multisystem hypertensive disorder of pregnancy. While the aetiology of pre-eclampsia remains largely unknown, the grave complications associated with it have driven development of novel methods for predicting its onset.

Pre-eclampsia and Epidemiology

Pre-eclampsia is traditionally defined as new onset hypertension and proteinuria in pregnancy1, however, the International Federation of Gynaecology and Obstetrics’ (FIGO) clinical definition describes it as sudden onset hypertension (>20 weeks of gestation) and at least one of the following: proteinuria, maternal organ dysfunction or uteroplacental dysfunction2. It is responsible for an estimated 70’000 maternal deaths, and 500’000 foetal deaths globally3. Pre-eclampsia affects around 4% of pregnancies in the US and is more common in low-to-middle income countries (LMICs), displaying an overall pooled incidence of 13% in a cohort from sub-Saharan Africa4. The risk factors for pre-eclampsia are shown in the graphic below.

Pre-eclampsia is associated with increased morbidity and mortality worldwide. In the US, pre-eclampsia is the foremost cause of maternal death, severe maternal morbidity, maternal intensive care admissions and prematurity5.

Classical classification of pre-eclampsia included early-onset (<34 weeks gestation) and late-onset (>34 weeks gestation). However, this classification lacks clinical utility as it does not accurately illustrate maternal or foetal prognosis. Therefore, the International Society for the study of Hypertension in Pregnancy (ISSHP) and contemporary studies prefer to classify pre-eclampsia as preterm (delivery <37 weeks of gestation), term (delivery ≥37 weeks of gestation) and postpartum pre-eclampsia (after delivery).

Complications

Pre-eclampsia has been associated with acute and chronic complications for both mother and child. Worldwide risk of maternal and foetal morbidity displays adjusted odds ratios of 3.73 and 3.12, respectively (pre-eclampsia vs non pre-eclampsia)6.

Acute Maternal Complications

A range of neurological complications are associated with pre-eclampsia. The most obvious is eclampsia, defined as seizures in pregnant women commonly from 20 weeks of gestation or after birth7. Eclampsia has two proposed mechanisms: abnormal placentation reduces blood supply and causes oxidative stress, leading to endothelial damage; and elevated blood pressure in pre-eclampsia disrupts cerebral vasculature, causing hypoperfusion and damage8. In high-income countries (HICs), most women make a full recovery, however, more severe cases of eclampsia can result in permanent disability or brain damage7.

Stroke is a significant complication of pre-eclampsia, constituting 36% of strokes related to pregnancy9. The hypertension characteristic of pre-eclampsia can weaken the walls of blood vessels causing subarachnoid or intracerebral haemorrhage resulting in haemorrhagic stroke. Ischaemic stroke is also of concern due to blood clotting complications which will be discussed later.

Additonal neurological complications include visual scotoma, cortical blindness, cerebral venous sinus thrombosis, cerebral vasoconstriction syndrome and posterior reversible encephalopathic syndrome (PRES). Notably, the last three in this list frequently manifest postpartum without warning6.

HELLP (Haemolysis, Elevated Liver enzymes and Low Platelets) syndrome is a liver and blood clotting disorder and life-threatening complication of pre-eclampsia. HELLP syndrome most commonly presents immediately postpartum but can manifest any time after 20 weeks of gestation7. Microangiopathy, or small blood vessel disorder, leads to ischaemia and a subsequent increase in oxidative stress and inflammation, causing an increase in liver enzymes and participates in the initiation of HELLP. Thrombocytopenia, or platelet deficiency, is considered a product of platelet depletion resulting from heightened platelet activation triggered by widespread endothelial damage6.

Another blood clotting condition associated with pre-eclampsia is Disseminated intravascular coagulation (DIC)7, described as the dysfunction of the maternal blood clotting system resulting in multiple organ dysfunction syndrome10. DIC can cause excessive bleeding due to lack of clotting proteins, or the formation of clots due to overactive clotting proteins, ultimately causing organ damage10.

As described earlier, proteinuria is included in the diagnostic criteria for pre-eclampsia, suggesting involvement of the kidneys. This is caused by high concentrations of soluble FMS like Tyrosine kinase 1 (sFLT-1), a placental angiogenic factor, which inhibits proteins of the podocyte slit diaphragm6; the machinery involved in preventing the leakage of proteins into the urine11. Reduced levels of Vascular Endothelial Growth Factor (VEGF) and Placental Growth Factor (PlGF) stimulates Endothelin 1 expression6, known to promote podocyte detachment, further contributing to proteinuria12.

Finally, Pulmonary oedema, excessive fluid accumulation in the lungs, is an acute and life-threatening complication associated with pre-eclampsia, the likelihood of which is increased via administration of antihypertensive medications6.

Acute Neonatal Complications

There are several documented complications affecting the baby of a pre-eclamptic mother. Firstly, Intrauterine growth restriction (IUGR) can result in underdevelopment of the foetus because of deficient transfer of oxygen and other nutrients from mother to child13. This can result in low birth weight, particularly when pre-eclampsia occurs prior to 37 weeks of gestation7. In pre-eclampsia with severe symptoms, delivery frequently occurs prematurely, either spontaneously or through induction. Preterm delivery can result in complications such as neonatal respiratory distress syndrome and neonates often require ICU admission7. Additionally, there is increased risk of stillbirth in pre-eclamptic pregnancies with relative risk shown to be 1.45 (95% Cl 1.20-1.76)14. Other complications documented in neonates born through pre-eclamptic pregnancies include neonatal thrombocytopenia, bronchopulmonary dysplasia, and a range of neurodevelopment outcomes15.

Long-term Complications

The only known cure for pre-eclampsia is delivery. However, the complications for both mother and child can last long after even an uncomplicated delivery. After a pre-eclamptic pregnancy, women are increased risk of end stage renal disease (4.7-fold), stroke (4-fold) and vascular dementia (3-fold) later in life5. Women are also at increased risk of other cardiovascular disease (CVD) including chronic hypertension, coronary artery disease, congestive heart failure5, and ischaemic heart disease13. In offspring, IUGR increases the risk of development of hypertension and other CVD13. Finally, offspring have been shown to be at higher risk of increased body mass index, changes in neuroanatomy, reductions in cognitive function, and hormonal abnormalities13.

sFLT-1/PlGF ratio

The pathophysiology of pre-eclampsia is complex and enigmatic. However, placental dysfunction is known to be a factor in pre-eclampsia development. The placental-related angiogenic factors, sFLT-1 (anti-angiogenic) and PlGF (pro-angiogenic), have been implicated in this development. This ratio provides a useful measure of placental dysfunction as a sharp increase in sFLT-1 and decrease in PlGF has been shown approximately 5 weeks before onset of pre-eclampsia16.

Until recently, diagnosis of pre-eclampsia was one of clinical manifestation. However, studies such as PROGNOSIS17 and PROGNOSIS Asia18, along with others19,20, have shown strong utility of this ratio. The PROGNOSIS study showed that a ratio cutoff of ≥38 was useful for ruling out pre-eclampsia within 1 week with a negative predictive value (NPV) of 99.3% or 4 weeks with a positive predictive value (PPV) of 36.7%17. The definitions of pre-eclampsia used by ICCHP and American College of Obstetricians and Gynaecologists (ACOG) have a PPV of around 20%, but when used in combination with the sFLT-1/PlGF ratio, the PPV is enhanced to 65.5% for ruling in pre-eclampsia within 4 weeks.21.

Similar results have been shown in an Asian cohort in the PROGNOSIS Asia Study. Using the same cutoff value, this study reported an NPV of 98.9%18. Furthermore, in a sub analysis of this cohort that looked at Japanese participants, a cutoff of ≥38 displayed an NPV of 100% for ruling out pre-eclampsia within 1 week and a PPV of 32.4% for ruling in within 4 weeks22.

Accurate Identification is Essential

Like all clinical assays, those used to determine the sFLT-1/PlGF ratio are subject to rigorous quality control, essential to ensure accurate results and diagnosis. The complications of pre-eclampsia are severe and often life-threating for both mother and child. Early and accurate identification is imperative for optimal monitoring, management, and timely interventions to reduce the risk of the grave consequences associated with pre-eclampsia.

The utility of the sFLT-1/PlGF ratio has been shown over various large cohorts and provides improved identification when used in combination with established clinical definitions. While the enigma of pre-eclampsia persists, the dedication of the scientific community to unravel its complexities ensures a future where expectant mothers may benefit from more effective and tailored strategies to mitigate the risks associated with this puzzling condition. Continued research endeavours will undoubtedly shape the landscape of maternal-foetal medicine, fostering advancements that hold the promise of improved outcomes for both mothers and their unborn children.

At Randox Quality Control,  we’ve introduced our Pre-eclampsia Control to the Acusera IQC range for use with in vitro diagnostic assays for the quantitative determination of PlGF and sFlt-1 in human serum and plasma.

Our true third-party Pre-eclampsia control comes with clinically relevant, assayed target values, is liquid-frozen for user convenience, utilises a human-based, commutable matrix, and has a 30-day open vial stability.

For more information on this, or any of our other controls, browse our brochure, or reach out to us today at marketing@randox.com for more information.

References

  1. American College of Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Hypertension in Pregnancy. Obstetrics & Gynecology. 2013;122(5):1122-1131. doi:10.1097/01.AOG.0000437382.03963.88
  2. Poon LC, Shennan A, Hyett JA, et al. The International Federation of Gynecology and Obstetrics (FIGO) initiative on pre‐eclampsia: A pragmatic guide for first‐trimester screening and prevention. International Journal of Gynecology & Obstetrics. 2019;145(S1):1-33. doi:10.1002/ijgo.12802
  3. Karrar SA, Hong PL. Preeclampsia. StatPearls Publishing; 2023.
  4. Jikamo B, Adefris M, Azale T, Alemu K. Incidence, trends and risk factors of preeclampsia in sub-Saharan Africa: a systematic review and meta-analysis. PAMJ – One Health. 2023;11. doi:10.11604/pamj-oh.2023.11.1.39297
  5. Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia. Circ Res. 2019;124(7):1094-1112. doi:10.1161/CIRCRESAHA.118.313276
  6. Dimitriadis E, Rolnik DL, Zhou W, et al. Pre-eclampsia. Nat Rev Dis Primers. 2023;9(1):8. doi:10.1038/s41572-023-00417-6
  7. NHS. Pre-eclampsia. Health A to Z. Published September 28, 2021. Accessed January 3, 2024. https://www.nhs.uk/conditions/pre-eclampsia/complications/
  8. Magley M, Hinson MR. Eclampsia. StatPearls Publishing; 2023.
  9. Crovetto F, Somigliana E, Peguero A, Figueras F. Stroke during pregnancy and pre-eclampsia. Curr Opin Obstet Gynecol. 2013;25(6):425-432. doi:10.1097/GCO.0000000000000024
  10. Costello RA, Nehring SM. Disseminated Intravascular Coagulation. StatPearls Publishing; 2023.
  11. Kawachi H, Fukusumi Y. New insight into podocyte slit diaphragm, a therapeutic target of proteinuria. Clin Exp Nephrol. 2020;24(3):193-204. doi:10.1007/s10157-020-01854-3
  12. Trimarchi H. Mechanisms of Podocyte Detachment, Podocyturia, and Risk of Progression of Glomerulopathies. Kidney Dis (Basel). 2020;6(5):324-329. doi:10.1159/000507997
  13. Turbeville HR, Sasser JM. Preeclampsia beyond pregnancy: long-term consequences for mother and child. American Journal of Physiology-Renal Physiology. 2020;318(6):F1315-F1326. doi:10.1152/ajprenal.00071.2020
  14. Harmon QE, Huang L, Umbach DM, et al. Risk of Fetal Death With Preeclampsia. Obstetrics & Gynecology. 2015;125(3):628-635. doi:10.1097/AOG.0000000000000696
  15. Backes CH, Markham K, Moorehead P, Cordero L, Nankervis CA, Giannone PJ. Maternal Preeclampsia and Neonatal Outcomes. J Pregnancy. 2011;2011:1-7. doi:10.1155/2011/214365
  16. Verlohren S, Galindo A, Schlembach D, et al. An automated method for the determination of the sFlt-1/PIGF ratio in the assessment of preeclampsia. Am J Obstet Gynecol. 2010;202(2):161.e1-161.e11. doi:10.1016/j.ajog.2009.09.016
  17. Zeisler H, Llurba E, Chantraine F, et al. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. New England Journal of Medicine. 2016;374(1):13-22. doi:10.1056/NEJMoa1414838
  18. Bian X, Biswas A, Huang X, et al. Short-Term Prediction of Adverse Outcomes Using the sFlt-1 (Soluble fms-Like Tyrosine Kinase 1)/PlGF (Placental Growth Factor) Ratio in Asian Women With Suspected Preeclampsia. Hypertension. 2019;74(1):164-172. doi:10.1161/HYPERTENSIONAHA.119.12760
  19. Hughes RCE, Phillips I, Florkowski CM, Gullam J. The predictive value of the sFlt‐1/PlGF ratio in suspected preeclampsia in a New Zealand population: A prospective cohort study. Australian and New Zealand Journal of Obstetrics and Gynaecology. 2023;63(1):34-41. doi:10.1111/ajo.13549
  20. Nikuei P, Rajaei M, Roozbeh N, et al. Diagnostic accuracy of sFlt1/PlGF ratio as a marker for preeclampsia. BMC Pregnancy Childbirth. 2020;20(1):80. doi:10.1186/s12884-020-2744-2
  21. Verlohren S, Brennecke SP, Galindo A, et al. Clinical interpretation and implementation of the sFlt-1/PlGF ratio in the prediction, diagnosis and management of preeclampsia. Pregnancy Hypertens. 2022;27:42-50. doi:10.1016/j.preghy.2021.12.003
  22. Ohkuchi A, Saito S, Yamamoto T, et al. Short-term prediction of preeclampsia using the sFlt-1/PlGF ratio: a subanalysis of pregnant Japanese women from the PROGNOSIS Asia study. Hypertension Research. 2021;44(7):813-821. doi:10.1038/s41440-021-00629-x

 

 


Meeting Accreditation Guidelines with Acusera 24.7

At Randox Quality Control, we are never finished shouting about how great our interlaboratory comparison and peer group reporting software is. If you’ve had a look yourself, you’ll know exactly why. Acusera 24.7 is full of fetching, interactive charts, and useful, detailed reports, including measurement uncertainty, to help you streamline your QC procedure.

But Acusera 24.7 is so much more than this. Our team are constantly looking for innovative ways to update and improve our live, cloud-based software. Much of this comes from talking to our subscribers and finding out what they want and how they want to do it. Our team also happens to include some serious accreditation enthusiasts. So, we decided to put their passion to work. We’re regularly coming up with new measures to make meeting the guidelines set out by various accreditation bodies, including ISO15189, as simple for you as we can.

In this article, we’ll look at some of the accreditation requirements and the features we’ve included in Acusera 24.7 to simplify the process for you.

QC management tools

Its one thing to look at the features of Acusera 24.7, but what do the various guidelines have to say about QC management tools? Let’s look at some of the major accreditation literature.

ISO15189:2022

The new version of ISO15189 includes updates which aim to place more emphasis on risk management and mitigating risk to the patient. Here’s what the 2022 version has to say about QC management tools:

“e) the resulting data shall be recorded in such a way that trends and shifts are detectable and, where applicable, statistical techniques shall be applied to review the results.

f) IQC data shall be reviewed with defined acceptability criteria at regular intervals, and in a timeframe that allows a meaningful indication of current performance.”

ISO15189:2022 section 7.3.7.2

The Clinical Laboratory Improvement Amendments 1988 (CLIA)

CLIA ’88 regulations are federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. These regulations state the following related to QC management:

“Lab surveys by CLIA accreditation bodies will request quality control records including:

a) Remedial action information; …

c) Statistical limits; and

d) Instrument maintenance and function checks records.”

4.93.1105 Standard: Retention requirements (a)(3) Analytical system records.

“Retain quality control and patient test records (including instrument printouts, if applicable) … for at least 2 years. The records must include charts, graphs, printouts, transcribed data, and manufacturers’ assay information sheets for control and calibration materials.”

CLIA Amendments 1988

COLA Accreditation

The Commission on Office Laboratory Accreditation (COLA) is another recognised laboratory accreditation in the U.S. and is a third-party accreditation organisation that ensures laboratories comply with federal regulations, including those set by CLIA. I’m sure you’re catching the trend here:

“Identification of individuals performing QC should be available in the QC records.”

“The Surveyor will review QC records, corrective action logs, reagent logs and maintenance or service records to make sure that controls were tested and acceptable. Documentation should include date of testing, initials of the individual performing, actual results and indication of acceptability.”

“The Surveyor will look for QC in a graphic format. Data may be graphed as Levey-Jennings Chart or similar graphic representation and reviews of graphs should be performed at least every 5-7 days of testing. The graphs do not have to be printed.”

“If there are shifts or trends demonstrated in the data, the Surveyor will expect to see notation by the staff and should be able to follow the documentation trail to corrective action that is taken, as required by the laboratory’s QC policies.”

“Control charts, graphs, or statistical  parameters (i.e. mean, SD and CV) should be maintained for all quantitative tests performed by the laboratory. This data should be reviewed weekly or following every 5-7 data points if performed infrequently to detect changes such as shifts or trends that may be indicators of test system problems that need to be addressed.”

“The Surveyor will review QC records for evidence of review – including initials/signature and date of the review. Reviews should take place at least on a monthly basis. If data point(s) fall outside the acceptable ranges, notation, and corrective action, if necessary according to the laboratory’s QC procedures, needs to be include in the review.

Corrective actions may include such actions as opening a new bottle of QC, replacing the reagent, or recalibration. Trends and shifts in QC should be noted as well.”

COLA Accreditation Manual, Section 3 – QC

Meeting accreditation with Acusera 24.7

Acusera 24.7 offers a flexible approach to help laboratories meet all the QC accreditation requirements detailed above, including CLIA, COLA, CAP, and ISO15189.

Our user-friendly, cloud-based software allows users to effortless run statistical analysis including Coefficient of Variation Index (CVI), Standard Deviation Index (SDI), % Bias, Total Error, Sigma Metrics and more! Find out more about how we can aid you in your statistical analysis in our blog, Advanced Statistics with Acusera 24.7.

Acusera 24.7 can also create fully interactive Levey-Jennings charts, and a selection of histograms to provide a wide range of options for the graphical representation of your data. The interactive features of our charts allow you to record events such as lot changes and calibration events directly on to the chart, helping you achieve not just accreditation, but a better understanding of what is going on in your laboratory. You can read more about our charts and the insights you can gain from them at our blog, Charting the course to laboratory excellence

Acusera 24.7 can also provide you with a variety of reports to help you effortlessly achieve accreditation. From our Statistical Analysis and Exception reports to our Personalised Performance Summary Reports, we can help your laboratory to efficiently identify and document trends or shifts in performance. You can read all about our reports in our blog, Effortless Data Management: Acusera 24.7 Reports

Measurement Uncertainty

Anyone involved in laboratory quality control will be aware of measurement uncertainty (MU), although that doesn’t mean everyone understands this tricky requirement. MU is defined as a parameter associated with the result of a measurement that characterises the dispersion of values that could reasonably be attributed to the measured quantity.

In other words, MU provides medical laboratories with an estimate of the overall variability in the values they report. The goal of MU is to quantify the doubt or range of possible values around the measurement result, helping to provide an understanding of the reliability and limitations of measurements. This helps ensure measured results are useful and not wildly inaccurate, allows meaningful comparisons with medical decision limits and previous results of the same kind in the same individual and finally, it’s a requirement of ISO15189:2022:

“a. The measurement uncertainty (MU) of measured quantity values shall be evaluated and maintained for its intended use. The MU shall be compared against performance specifications and documented.

b. MU evaluations shall be regularly reviewed.”

ISO15189:2022 Section 7.3.4

Calculating MU is no simple task and not one that can even be attempted without in depth know-how. These calculations can take a single member of staff 2 full working days to complete. That’s a lot of time away from their normal duties, especially if MU is to be reviewed regularly, as per ISO15189:2022.

Lucky for you, Acusera 24.7 can calculate you MU in seconds, rather than days, and provide you with a report. This report can be shown to your accreditation surveyor, and you can consider the MU box ticked. You can read more about Acusera 24.7 and MU in our Advanced Statistics blog, or in our educational guide How to Measure Uncertainty.

Peer Group Reporting

The peer group reporting features of Acusera 24.7 are much more than just an added extra. Peer group reporting can help speed up the troubleshooting process, allowing you to determine whether an issue you are seeing is unique to you, or evident in the QC data of your peers. It can also provide you with more confidence in assigned target values and help make significant savings by improving your analytical performance, and therefore, your EQA performance.

A peer group reporting programme can also help meet regulatory requirements, like ISO15189:2022:

“ a. The laboratory shall monitor its performance of examination methods by comparison with results of other laboratories. This includes participation in EQA programmes appropriate to the examinations and interpretation of examination results, including POCT examination methods.”

“f. When an EQA programme is either not available, or not considered suitable, the laboratory shall use alternative methodologies to monitor examination methods performance.

NOTE Acceptable alternatives include:

– Interlaboratory comparisons of the results of the examination of identical IQC materials, which evaluates individual laboratory IQC results against pooled results from participants using the same IQC material.”

ISO15189:2022 Section 7.3.7.3 External quality assessment (EQA)

So, if you’re struggling to find a suitable EQA programme for your analytes, you might just be able to meet your accreditation with the peer group reporting features included in Acusera 24.7.

We’ve only begun to cover the features of this intuitive and efficient software. If you still aren’t convinced that Acusera 24.7 is right for QC data management in your laboratory, reach out to us today at marketing@randox.com. We’re always delighted to hear from you, and we’ll be happy to discuss any of the features of Acusera 24.7, or any reservations you may have.

Our customers can’t believe the gulf in class between Acusera 24.7 and other QC data management programmes.

Don’t get left behind.

Reach out to us today!


International Day of Women and Girls in Science 2024

For the 9th consecutive year, the field of science has taken this day to celebrate women in the STEM industries and their achievements. The representation of women in STEM is climbing, however it remains low, with estimates claiming women make up only around 26% of the workforce. By celebrating the accomplishments of women in these fields, we hope to encourage more girls to enter the world of science and engineering and challenge the adversity women in STEM all too often face.

In honour of International Day of Women and Girls in Science 2024, we’ve looked at some of the most important achievements in the life sciences. Some of the names you’ll be familiar with, others may be new. We’ll travel to Ancient Greece where we will learn about the first female science writer and surgeon, before coming back to today to recognise some of the most groundbreaking innovations in medicine. For far too long the door to a career in the life sciences has been all but closed for women, as you will discover in this article. Yet some of the discoveries and triumphs over adversity we’ll look at are arguably some of the most important achieved by humanity.

Metrodora

In Ancient Greece, it was believed that science was derived directly from the gods. This meant, like other divine disciplines, women were not allowed to practice medicine. However, such a technicality did not stop our first heroine of science. Before her exploits in Greece, Metrodora was likely born and educated in Egypt where men and woman were equals, unlike much of the ancient world. In fact, some believe Metrodora to be an alias of the famous Cleopatra VII, Queen of Egypt. There is some debate about when Metrodora lived; some say between 200-400 CE, others claim it was more likely to be during the 7th century CE. The name Metrodora is particularly fitting for a woman of her accolades. In Greek, metro can be translated as womb, and dora means gift.

Metrodora was the author of a textbook, making her the first female science writer, spanning 2 volumes and 108 chapters entitled On the Disease and Cures of Women, in which she describes in detail her theories and findings on the topics of female health and the reproductive system. She is thought to have devised treatments for sterility, infections of the female reproductive system, menorrhagia (heavy periods) as well as a method for determining sexual abuse in women. Not to be limited by writing and medicine, Metrodora was also a surgeon, cited as removing dead embryos to save the lives of mothers who miscarried, removing cancers of the breast and uterus and was even among the first to perform cosmetic surgery. Metrodora reconciled this with her Hippocratic duty to help women who had been abused through aesthetic facial and breast reconstruction and the restructuring of the hymen of women who had suffered this fate.

Her pioneering work, however, was quite nearly forgotten forever as she was largely overlooked by her contemporaries. But thankfully, some of her texts are preserved in the Laurentian Library in Florence. Metrodora’s commitment to medicine and female health is summed up perfectly in the opening words of her text, “some of them are intricate to treat and others are fatal, by these notes we will recognise each one”.

 

 

 

Elizabeth Blackwell (1821-1910)

Elizabeth Blackwell was always destined to shake the status quo. Her father, Samuel, was a Quaker and an antislavery activist. Among her siblings are Henry, an abolitionist and women’s suffrage supporter; her sister, Emily, who followed Elizabeth into medicine; and her sister-in-law, Antoinette Brown Blackwell, who was the first female minister in mainstream Protestantism.

She was inspired into a life of medicine after a close friend had confessed embarrassment of her treatment by male doctors and suggested she’d have been more comfortable if attended to by a female physician. After a series of rejections from numerous medical schools, Elizabeth was finally accepted to Geneva College, New York. However, this acceptance was intended as a practical joke. Not to be discouraged, Elizabeth proved them all wrong, graduating top of her class in 1849 and becoming the first woman to graduate medical school. Dr Blackwell then practiced in London and Paris and was one of the first advocates for the importance of hygiene in medicine, noting that male doctors frequently failed to wash their hands, which led to the spread of epidemics.

In 1851, Elizabeth made the trip back to New York where discrimination was still rife. Once again, her persistence led to the opening of the New York Infirmary for Women and Children in 1857 with Dr Emily Blackwell and Dr Marie Zakrzewska. This institution was a haven for women who needed medical treatment but were often too poor to afford it, and for female physicians struggling to get work in the field. Among her laurels, she played a role in the inception of the National Health Society, established in 1871, which aimed to spread knowledge of public health, and is considered the predecessor to the National Health Service.

 

 

Marie Curie (1867-1934)

Marie Curie is among the most famous of the women in science, so we won’t spend too much time on her life and accomplishments here. However, its impossible to have the discussion without mentioning her invaluable contribution to science. In often poor laboratory conditions with worse equipment, she, and her husband Pierre Curie, made some pivotal discoveries including the isolation of polonium and radium. Marie Curie developed techniques to separate radium from radioactive residues which allowed it to be studied extensively and eventually, its use as a therapeutic agent.

In 1903, Marie and Pierre Curie were awarded half of the Nobel Prize for Physics for their work on spontaneous radiation. Then, in 1911, Marie Curie was given a second Nobel Prize, this one for chemistry, for her work on radioactivity. In recognition of her groundbreaking work leading to novel cancer therapies, the charity Marie Curie was named in her honour, immortalising her and her contributions to the field.

Marie Curie, 1867-1934

Gerty Cori (1896-1957)

Here we find another woman whose name outshines that of her husband, Carl, with whom she collaborated for most of her scientific career. Gerty graduated from medical school in 1920, along with her husband, before they emigrated to America in 1922. Here, they initially delved into the fate of sugar within the animal body, exploring the impacts of insulin and epinephrine. They made groundbreaking discoveries, including the demonstration of glycolysis in tumours in vivo. Their research on carbohydrate metabolism evolved from whole animal studies to experiments on isolated tissues, and eventually to tissue extracts and isolated enzymes, including some in crystalline form. In a pivotal moment in 1936, they isolated glucose-1-phosphate, known as “Cori ester,” and linked its formation to the activity of phosphorylase, which plays a crucial role in the breakdown and synthesis of polysaccharides. This discovery paved the way for the enzymatic synthesis of glycogen and starch in vitro.

Their research extended into the realm of hormone action mechanisms, with several studies focusing on the pituitary gland. They observed significant changes in rats that have had their pituitary gland removed, including a marked decrease in glycogen and a drop in blood sugar levels, accompanied by an increased rate of glucose oxidation. Further investigations into the effects of hormones on hexokinase revealed that certain pituitary extracts could inhibit this enzyme both in vivo and in vitro, while insulin was found to counteract this inhibition.

Beyond their groundbreaking research, the Cori’s served as an endless source of inspiration to their peers in the vibrant hubs of biochemical research they led. Their contributions to The Journal of Biological Chemistry and numerous other scientific journals have left an indelible mark on the field, showcasing their innovative work and collaborative spirit throughout their careers.

 

 

 

 

https://www.nlm.nih.gov/changingthefaceofmedicine/gallery/photo_69_3.html

Gertrude Belle Elion (1918-1999)

Gertrude provides us with another tale of the triumph over adversity. After graduating with a degree in biochemistry in 1937, she failed to obtain a graduate position because she was a woman. After roles in laboratories and teaching, she joined the Burroughs Wellcome Laboratories in 1944 and became the assistant to Dr George Hitchings. Over the following 40 years, the pair were successful in the development of a vast array of new drugs and treatments. Much of their success is attributed to their methods. At the time, normal practice is best described as trial and error. However, Hitchings and Elion studied and intimately understood the difference between normal and pathogenic biochemistry, allowing them to envision and create targeted treatments for, to name just a few, leukaemia, urinary-tract infection, gout, malaria and viral herpes.

Although she never achieved her doctorate, in 1967 Elion was promoted to Head of the Department of Experimental Therapy, where she remained until her retirement in 1983. But Elion didn’t let a silly old thing like retirement get in her way. She remained at the Burroughs Wellcome Laboratories as a Scientist Emeritus and Consultant, including overseeing the development of azidothymidine, the first drug used to treat AIDS. Elion also became a Research Professor of Medicine and Pharmacology at Duke University, working with medical students in the field of tumour biochemistry and pharmacology, while continuing to write and lecture. Gertrude B. Elion passed away in 1999, bringing an end to a happy and fruitful career as one of the most influential women in science.

 

GSK Heritage Archives

https://creativecommons.org/licenses/by/4.0/
GSK Heritage Archives https://creativecommons.org/licenses/by/4.0/

Rosalind Franklin (1920-1958)

Rosalind Franklin, another well-known name and one synonymous with the discovery of the DNA double helix, was an exceptional scientist whose meticulous work in X-ray crystallography laid the groundwork for one of the 20th century’s most significant scientific discoveries. Franklin graduated from Cambridge University in 1941, where she initially delved into the study of coal, gases, and carbon compounds, significantly contributing to the understanding of the molecular structures of these materials. Her early research not only showcased her exceptional skills in physical chemistry but also set the stage for her pioneering work in biology.

In 1951, Franklin joined King’s College London, where she was tasked with improving the X-ray crystallography unit. It was here that Franklin embarked on her most famous work: the study of the structure of DNA. Using her expertise in X-ray diffraction techniques, she captured Photograph 51, a critical piece of evidence revealing the helical structure of DNA. This image was crucial in identifying the double helix structure, although her contributions were not fully acknowledged until after her death.

Franklin’s research extended beyond DNA to the study of viruses, making significant strides in understanding the polio virus and the tobacco mosaic virus. Her work in virology, much like her work on DNA, was pioneering, employing her crystallography skills to uncover the detailed structure of viral particles. This work provided valuable insights into how viruses replicate and infect cells, contributing to the broader field of virology and paving the way for future research in virus structure and function.

Despite facing considerable challenges as a woman in a predominantly male scientific community, Franklin’s contributions were profound. Her relentless pursuit of scientific truth, combined with her exceptional experimental skills, left a legacy in the fields of chemistry, virology, and genetics. Beyond her scientific achievements, Franklin is remembered as a trailblazer who paved the way for future generations of women in science, demonstrating the critical role of perseverance and dedication in the pursuit of knowledge.

 

 

 

 

 

 

The Editors of Encyclopaedia Britannica. "Rosalind Franklin, British Scientist," Encyclopaedia Britannica (article created 20 Jul 1998, accessed 08 Jan 2024); https://www.britannica.com/biography/Rosalind-Franklin : https://cdn.britannica.com/30/99730-050-E68F62FF/Rosalind-Franklin.jpg
The Editors of Encyclopaedia Britannica. "Rosalind Franklin, British Scientist," Encyclopaedia Britannica (article created 20 Jul 1998, accessed 08 Jan 2024); https://www.britannica.com/biography/Rosalind-Franklin : https://cdn.britannica.com/30/99730-050-E68F62FF/Rosalind-Franklin.jpg

Françoise Barré-Sinoussi (1947-)

When discussing women who changed science, it’s impossible not to mention Françoise Barré-Sinoussi. She was born in Paris in 1947 and attended university there. Her passion for science saw her skip class to work at the Pasteur Institute, participating in investigations of retroviruses that caused leukaemia in mice. Although, this didn’t seem to affect her exams scores, and she received her PhD in 1974.

Françoise Barré-Sinoussi is hailed as the woman who discovered the viral cause of the AIDS epidemic. In 1982, the Pasteur Institute was approached by a virologist from a hospital in Paris, seeking help in identifying the cause of a worrying new epidemic. In a mere 2 weeks, Barré-Sinoussi, and her colleagues at the Pasteur Institute, isolated and grew a retrovirus from a biopsied lymph node of a patient at risk of AIDS. The virus, later named HIV-1, was found to be the cause of the AIDS epidemic.

Barré-Sinoussi has been contributing to virology research ever since, including areas such as the function of the host’s innate immune defences in managing HIV/AIDS, the elements contributing to the transmission of HIV from mother to child, and traits enabling a select group of HIV-positive individuals to restrain HIV replication without the need for antiretroviral medications. In 1992, Barré-Sinoussi was appointed Head of the Biology of Retrovirus Unit, renamed the Regulation of Retroviral Infections Unit in 2005.

However, Barré-Sinoussi didn’t stop at the science. She became a prominent activist for public education about AIDS prevention and helped to establish centres for diagnosing and treating AIDS around the world. In 2006, Barré-Sinoussi was elected to the International AIDS Society (IAS) Governing Council and served as president of the IAS from 2012-2016.

 

https://en.wikipedia.org/wiki/Fran%C3%A7oise_Barr%C3%A9-Sinoussi#/media/File:Fran%C3%A7oise_Barr%C3%A9-Sinoussi-press_conference_Dec_06th,_2008-1.jpg

http://www.gnu.org/licenses/old-licenses/fdl-1.2.html
https://en.wikipedia.org/wiki/Fran%C3%A7oise_Barr%C3%A9-Sinoussi#/media/File:Fran%C3%A7oise_Barr%C3%A9-Sinoussi-press_conference_Dec_06th,_2008-1.jpg http://www.gnu.org/licenses/old-licenses/fdl-1.2.html

Jennifer Douda and Emmanuelle Charpentier

Most people have heard of CRISPR-Cas9. But many aren’t aware that we have women to thank for this scientific innovation. In 2012, Jennifer Douda (left) and Emmanuelle Charpentier (right) discovered the ingenious CRISPR-Cas9 technology – a groundbreaking tool in genetic engineering, which holds the promise of revolutionising medicine and biology. By enabling precise editing of the DNA in the cells of living organisms, CRISPR-Cas9 could lead to cures for genetic disorders, enhance crop resistance to pests and diseases, and advance our understanding of complex genetic conditions. It offers the potential to correct genetic defects, combat infectious diseases, and even manipulate traits in plants and animals, paving the way for significant advancements in therapeutic treatments, agricultural productivity, and the study of genetics. This discovery saw both women share the Nobel Prize in Chemistry in 2020.

 

Photograph by Christopher Michel https://creativecommons.org/licenses/by/4.0/

 

https://upload.wikimedia.org/wikipedia/commons/6/66/Emmanuelle_Charpentier.jpg https://creativecommons.org/licenses/by/4.0/

We’ve only looked at a subsection of science, but one where the importance of the innovations and discoveries is felt by people every day. The scientists we’ve discussed here are only a small sample of the inspirational women that have graced the STEM field. We hope that by elucidating some of their work, we can inspire more girls and women to pursue a career in STEM. Careers in this field are challenging and rewarding, perfect for those with a curious mind and those in whom discovery sparks delight.


Free health checks in Sandwell

 

Sandwell residents will be able to benefit from diagnostic NHS Health Checks, testing for diabetes, heart and kidney disease, and hyper tension.

After the launch of Sandwell Council’s partnership with Randox Health in 2023,which saw thousands of eligible Sandwell residents offered diagnostic NHS Health Checks, the partnership has continued – giving residents a health boost for 2024!

Free tests will be offered to Sandwell residents aged between 40 and 70 who have not previously suffered coronary heart disease, strokes, diabetes, or kidney disease. Over the next few weeks those eligible will receive letter inviting them to the 20-minute NHS Health Check, under joint branding from Randox, Healthy Sandwell and the NHS.

Tests and clinics will be available for Sandwell residents in both Sandwell and, if convenient, in Birmingham, with additional free body composition analysis for health checks completed at the Birmingham clinic. Results will be made available for GPs for review and inclusion on patient medical records.

Not only does the testing programme enable prevention and mitigation through he early identification of serious illness, but it also allows lifestyle modification on issues including smoking, alcohol, and weight management. This partnership also includes a limited number of 3-month free gym memberships.

Councillor Suzanne Hartwell, Sandwell Council’s Cabinet Member for Adults, Social Care & Health, said: “The good health of our residents has always been a priority for the Council. This initiative will have a significant and beneficial impact on the health and longevity of thousands of people living in the area. It will enable those at high risk to take medical and lifestyle steps to prevent illnesses which could, if not detected early, shorten, or change lives.”

David Ferguson, Chief Operating Officer for Randox Health said, “Randox is delighted to be part of this joint initiative with Sandwell Council’s Public Health Team. It has long been our belief that early diagnostic health testing delivers better outcomes for individuals. It relieves the pressure on our NHS by enabling lifestyle change and medical intervention. This in turn, prevents or mitigates illnesses which could otherwise require intense long-term treatment.”


UKAS ISO15189:2022 Transition Update

Throughout 2023, UKAS have been hard at work training Assessment Managers and Technical Assessors on the new requirements of the updated ISO15189 guidelines, sharing information about the updated standard and developing the UKAS 15189:2022 Transition Hub providing a one-stop-shop for information on the ISO15189:2022 update.

Recently, UKAS have published a Transition update to remind laboratories of where they stand in seeking their updated accreditation.  In this update, UKAS state “As per the UKAS transition plan, all assessments due to take place from the 1st January 2024 will be to ISO15189:2022.”

A gap analysis will be required one month prior to transition assessments, detailing the gaps and the actions which have been taken to remedy these gaps. This should include evidence, such as updated documents and records, embedded in the gap analysis document, showing what action has been taken to bring a laboratory’s practices in line with the updated standard.

An important note included in this transition update is , “UKAS cannot grant accreditation on intent; organisations shall make the necessary changes and have implemented these prior to the transition assessment.” So if your accreditation assessment is due soon, you might want to make use of our ISO15189:2022 Accreditation Guide to assist you in your gap analysis to ensure you don’t miss out.

This is crucial for laboratories because failure to align with the 2022 version of the standard before the deadline of 6th December 2025 will result in a suspension of ISO15189 accreditation for up to 6 months.

Some of the key accreditation updates include:

You can find more information to assist in your gap analysis and achieving ISO15189:2022 accreditation our ISO15189:2022 Accreditation Guide – a free PDF is available below.

Randox Quality Control’s Acusera range provides true third part quality controls designed to help you achieve all aspects of ISO15189:2022 accreditation including commutable matrices containing consistent, clinically relevant concentrations with unrivalled consolidation of analytes. To learn more about our range of quality control products, visit our website or, get in touch today at marketing@randox.com


Advanced Statistics with Acusera 24.7

The only thing that sounds more terrifying than statistics, is advanced statistics. For many of us, the dread associated with having to carry out complex calculations can be too much to bear.  For others, statistics are not just a set of numbers; they’re a captivating puzzle waiting to be solved. The allure of dissecting intricate patterns, unravelling hidden relationships, and drawing meaningful conclusions makes these statistical enthusiasts embrace the challenges of advanced statistics with excitement rather than apprehension.

No matter which camp you’re in, we bet you’re going to love the advanced statistics features included in Acusera 24.7. From Uncertainty of Measurement to Sigma Metrics, we’ve got you covered. Let’s explore these features and how we can make your statistical analysis easier than ever before.

Measurement Uncertainty

If you’re involved in laboratory quality control, you’ll have heard all about measurement uncertainty (MU). To some it’s intuitive. To some it’s a labyrinth. MU is defined as a parameter associated with the result of a measurement that characterises the dispersion of values that could reasonably be attributed to the measured quantity. For example, if we say the pencil below measures 16cm ± 1cm, at the 95% confidence level we are really saying that we are 95% sure that the pencil measures between 15cm and 17cm.

In other words, the calculation of MU gives medical laboratories an estimate of the overall variability in the values they report. This is important for 3 reasons:

  1. It helps ensure the measured results are useful and not wildly inaccurate.
  2. It permits meaningful comparison of medical decision limits and previous results of the same kind in the same individual.
  3. It’s a regulatory requirement – ISO 15189:2022

All measurements involve some degree of inherent variability due to factors such as instrument limitations, environmental conditions, and biological variation. MU aims to quantify the doubt or range of possible values around the measurement result, helping to provide an understanding of the reliability and limitations of measurements. To complete this task comprehensively, the entire measurement process must be examined and should consider components such as systematic errors, random errors and uncertainties related to calibration, equipment, and the environment.

ISO 15189:2022 states:

So, if you are seeking ISO15189 accreditation, there’s no avoiding MU and advanced statistics. Lucky for you, Acusera 24.7 can calculate MU and provide you with a report which you can export to Excel or PDF for auditing or archiving.

By liberating you from the need to manually calculate MU for all your assays and control levels, Acusera 24.7 streamlines the statistical analysis process, freeing you up to complete your other essential duties. It also helps reduce the chance of errors in the calculation; after all, no matter how talented you are at mathematics, we all make mistakes. The real-time nature of this kind of monitoring means you don’t have to recalculate every time you get more data – simply press the refresh button and you’ll automatically get a new MU report.

By incorporating automated tools to calculate MU, you gain the ability to proactively pinpoint and rectify potential error sources, mitigating the risk of inaccurate measurements and the repercussions that may follow.

For more information on MU and how it’s calculated, see our education guide – How to Measure Uncertainty.

Sigma Metrics

The Sigma model was originally developed for the manufacturing industry as a method of process improvement focusing on minimising errors in process outputs. It has since been adopted by the medical laboratory to improve result reporting.

This model calculates the number of standard deviations or ‘Sigmas’ that fit within the quality specifications of the process – as the sources of error or variation are removed, the standard deviation becomes smaller, and the sigma score increases – 6 being the target. A 6 Sigma process can be expected to produce 3.4 defects, or false results, per million.

sigma6

Using your predetermined performance limits, including biological variation (standard), RiliBÄK and CLIA, as the total allowable error (TEa), Acusera 24.7 can calculate a Sigma Score for a particular assay, method, or instrument, saving you the hassle of calculating this manually – freeing you up to investigate the sources of error and make improvements to your process.

This is displayed in our Statistical Metrics report along with Count, Bias%, and CV for your chosen range, your cumulative results and those from other Acusera 24.7 users from around the world to provide straightforward and comprehensive statistical analysis and peer group comparison.

Once you’ve found out your Sigma Score for an assay, you can use this to determine your QC frequency and the multi-rules you should apply to your QC. The higher your Sigma Score, the less multi-rules you need to apply to your analysis and the less often you need to run QC for that assay. The table below shows the multi-rules and QC frequencies associated with each Sigma Score.

Acusera 24.7 includes multi-rule capabilities that can be utilised to monitor your QC data and index it as accepted, rejected, or trigger an alert, depending on the pre-defined multi-rules against which you want to check your data. These features enable the identification of nonconformities and reduce the need for laborious manual statistical analysis while enhancing the accuracy and precision of the laboratory. To read more about the multi-rule features of Acusera 24.7, take a look at our educational guide – Understanding QC Multi-rules.

Now that we’ve found which of our assays are underperforming, we can begin to take corrective action. The Sigma Score is affected by bias and imprecision of laboratory results, therefore improving these values will increase the Sigma Score. Some of the steps a laboratory can take are:

  • Improved staff training
  • Instrument maintenance
  • Frequent calibration
  • Strict adherence to SOPs when preparing controls and calibrators.

If you are still in the dark ages, carrying out your statistical calculations and analysis manually, reach out to us today to learn more about the time and expense we can help you save. Every day, more people are discovering the power of Acusera 24.7 and the benefits it has in their laboratory.

The updates to ISO151589:2022 are based around increasing patient safety and reducing erroneous results, making advanced statistics essential. Assessors get excited when they see Acusera 24.7 in the lab because they know quitting time is that bit closer. Allow us to help you achieve your accreditation and provide the best possible patient care. With complete onboarding assistance and first-class customer support, you’ll always be ready to get to the bottom of any problems you might face. Get in touch today at marketing@randox.com


World Diabetes Day

World Diabetes Day!

14th November

Diabetes is a life-long condition that affects millions of people worldwide. It causes blood sugar levels to become abnormally high, which poses a significant danger to your body. Although it’s incurable, it can be monitored and controlled.

Randox Laboratories provide a range of diabetes related diagnostic reagents, that cover many areas from disease recognition and diagnosis to monitoring symptoms and complications associated with the condition.

 

The three main types of Diabetes are Type 1, Type 2 and Gestational Diabetes.

Type 1 diabetes starts in early childhood, and is caused by a deficiency in the production of insulin by the pancreas. It can be both inherited and acquired. Daily monitoring is required, along with the administration of insulin. Type 1 is when your body can’t naturally produce the hormone insulin, vital for the transportation of glucose in the blood to the cells to energize and fuel our bodies. Your body attacks cells within the pancreas, meaning the body is unable to produce insulin. Without insulin there is no glucose getting into bodily cells, so it builds up in your blood stream causing high blood sugar levels.

 

Type 2 manifests later in life, it’s when the body produces insulin but does not use it effectively. Can be referred to as insulin resistance. It is more common than Type 1 and usually can be the cause of lack of exercise and excess body fat. However, regardless of weight it can occur in any individual. Type 2 diabetes can be regulated by your diet. Without treatment or action, diabetes can cause many serious problems like damaging the eyes, feet and heart. Some symptoms may include urinating more than usual, feeling lethargic, weight loss, blurred vision and wounds or cuts taking longer to heal.

 

Gestational diabetes is the development of the condition during pregnancy. It is the result of the body being unable to produce enough insulin to meet the extra needs of the baby and mother. It can cause serious problems if not controlled, to reduce the risks Gestational diabetes is consistently monitored.

Randox Laboratories provide an extensive range of reagents for the accurate testing of diabetes. One of the reagents is Fructosamine in which ‘testing has been identified as being the best for patient care’.

Fructosamine & HbA1c 

Fructosamine is a mid-term indicator of diabetic control, as it can provide information on a person’s average blood glucose levels over the previous 14-21 days. Because of it’s shorter time span, it’s often used to evaluate the effectiveness of medication changes and to monitor the treatment of gestational diabetes.

Fructosamine is also particularly useful in situations where HbA1c cannot be reliably measured e.g. haemolytic anaemia, thalassemia or with genetic hemoglobin variants.

HbA1c for example – gives us an indication of what an individual’s average blood sugar level has been over recent weeks/months. This is significant for those who suffer from diabetes because the higher the levels of HbA1c, the higher the chance of an individual suffering from further diabetes related issues.

The latex enhanced immunoturbidimetric method which the RX series utilises makes, the test simple and quick to perform. The removal of the pre-dilution step removes the risk of human error compromising your results. Certified by the National Glycohemoglobin Standardization Program (NGSP), the RX daytona+, RX imola & RX modena are all capable of utilising direct on-board HbA1c which can revolutionise your diabetes testing capabilities.

D-3-Hydroxybutyrate (Ranbut)

D-3-Hydroxybutyrate (Ranbut) is another reagent Randox provides.  D-3-Hydroxybutyrate is the most abundant of the three main ketones produced in the body, accounting for 75% of total ketones in the body. Due to the higher levels of D-3-Hydroxybutyrate, it is the more sensitive marker for the diagnosis of ketosis.

Ketosis is a metabolic process, occurring when the body switches from glucose to predominantly fat metabolism for energy production, this happens when carbohydrate availability reaches low levels. The metabolism of fatty acids in the liver, results in the production of chemical by-products known as ketone bodies or ketones. Ketosis occurs when the body produces more ketones than the liver can process.

High levels of ketones present in the body can be dangerous  leading to Diabetic Ketoacidosis, which being left untreated can cause damage to vital organs and in some instances may lead to a coma or death.

Benefits of Ranbut include;

• Superior methodology when compared to other commercially available ketone detection tests. For example, the nitroprusside method used in semi-quantitative dipstick tests only detects acetone and acetoacetate. D-3 hydroxybutyrate is the most abundant ketone produced during ketosis the measurement of this analyte is more sensitive and specific.
• Exceptional correlation coefficient of r=0.9954 when compared against other commercially available methods.
• Excellent precision of <3.5% CV.
• Calibrator and controls available offering a complete testing package.
• Applications available detailing instrument-specific settings for the convenient use of the Randox D-3- Hydroxybutyrate (Ranbut) assay on a wide range of clinical chemistry analysers.
• New liquid stable Ranbut assays available.

Non-Esterified Fatty Acids (NEFA)

Non-Esterified Fatty Acids is another reagent Randox provides, which are important metabolites stored in adipose tissue. The dominant source of NEFA is abdominal subcutaneous fat. Cross-sectional studies have consistently documented that circulating NEFA levels are proportional to body fat storage and demonstrated positive correlations between fasting NEFA levels and obesity, insulin resistance and glucose tolerance. It too is an accurate marker regarding diabetes.

Non-Esterified Fatty Acids concentrations are strongly associated with insulin resistance. In the fasting state, the resistance of adipose tissue to the antilipolytic effect of insulin causes the extensive release of NEFA into circulation. Consequently, elevated NEFA levels exacerbate insulin resistance through diminishing insulin- stimulated glucose intake into the skeletal muscle, directly affecting insulin signalling.

Benefits of NEFA include;
• Exceptional correlation coefficient of r=0.98 when compared against other commercially available methods.
• Excellent precision of <5% CV.
• Extensive measuring range of 0.072- 2.24mmol/l for the comfortable detection of clinically important results.
• Calibrator and controls available offering a complete testing package.
• Applications available detailing instrument-specific settings for the convenient use of the Randox NEFA assay on a wide range of clinical chemistry analysers.

Randox’s Reagents available for diagnosis and monitoring of diabetes.

Fructosamine

Glucose

HbA1c

Albumin

Creatinine

Cystatin C

D-3-Hydroxybutyrate

Microalbumin

Non-Esterified Fatty Acids

 

‘The Randox enzymatic method offers, improved specificity and reliability compared to the conventional NBT-based methods, as the enzymatic method does not suffer from non-specific interferences, unlike the existing methods which can also be time-consuming and difficult to automate. The Randox dedicated Fructosamine calibrator and controls are assigned relative to human serum glycated with 14-C glucose, directly reflecting the nature of the patient sample. Randox provides testing and reagents that are reliable and accurate.’

References

Anon (2023) Types of diabetes, Diabetes UK. Available at: https://www.diabetes.org.uk/diabetes-the-basics/types-of-diabetes (Accessed: 19 September 2023).

NHS (2023) Symptoms of Diabetes, NHS Choices. Available at: https://www.nhs.uk/conditions/type-2-diabetes/symptoms/ (Accessed: 19 September 2023).

Randox (2023) Diabetes Reagents: Biochemistry: Reagents, Randox Laboratories. Available at: https://www.randox.com/diabetes-reagents/ (Accessed: 19 September 2023).

Randox (2023b) Fructosamine: Reagents: Biochemistry, Randox Laboratories. Available at: https://www.randox.com/fructosamine/ (Accessed: 20 September 2023).


David Davis calls for blanket testing to save NHS Ā£3bn a year

 

Ministers are being urged to introduce mass medical testing to cut NHS costs by billions and save thousands of lives.

Former Brexit Secretary David Davis calls for mass medical testing across the whole UK population by companies which he believes will alert the NHS to potential health risks for individuals and allow for lifestyle changes and treatment before problems become serious.

Mr. Davis said, “I bring it back to the reality of individuals. If we delay diagnosis, we delay treatment – we sentence people to death. It’s as harsh as that. So one of the things I would like to see us do is dramatically increase the amount of diagnostic capacity we have.”

“My view is that actually we should break clear of the ideology. We should look to increase dramatically the amount of scans and diagnostic procedures we can create. And when I say dramatically, I mean a multiple of what we currently do and we should use the private sector to do it.

“I know it causes a bridling and a backing off but I the only way we can do it fast enough is to do that. And that will save I think about Ā£3 billion, get the waiting lists down by millions of people but most importantly of all will save thousands of lives.”

Mr. Davis was reacting to a paper drawn up by Northern Ireland medical testing company Randox, one of the private health providers who developed Covid testing during lockdown. The paper has been drawn up by scientists at Randox, scaling up its testing capacity from 300 tests a day to 120,000 a day in less than 12 months. Overall, the firm conducted nearly 27 million tests during the pandemic.

Dr. Peter Fitzgerald, the founder of Randox, said that with the NHS waiting lists not far short of eight million people and with budgets under intense pressure, the time had come for a new partnership between the public and private sectors.

Ministers should start by convening a summit of private diagnostic firms and their NHS counterparts and investigate the potential of the enormous advances in testing technologies developed in recent years. By harnessing the startling progress made by scientists they could revolutionize standards of health care while slashing waiting lists and achieving far greater value for money.

Dr. Fitzgerald added, “Policy-makers need to appreciate the vast potential of the latest diagnostic testing technologies. They can deliver a step-change in the quality of people’s lives. By outsourcing much testing to the private sector – under a rigorous independent tendering process – the NHS can be freed up toĀ  get on with its prime job of treating the sick.”

Under the Randox plan, the public would be invited to visit a private diagnostic clinic every year for a check-up. Results would be monitored in house by scientists who would advise people on next steps. Results would be routinely passed onto their GPs, though in many cases no further action would be needed.

GPs would ultimately decide on medical interventions and possible referral to NHS hospital services. A priority group for such tests would be the 7.7 million on NHS waiting lists. They would be assessed to see if their condition had worsened and whether urgent action was required.

High-tech comprehensive testing of the population would also reduce if not eliminate the many false positives arising from much of the diagnostic services available today.

Taken from Daily Express article by David Maddox, Political Editor.

Randox welcomed the Queenā€™s University staff Leadership Team to their Antrim based Randox Science Park in Antrim.

Randox were delighted to welcome the Queenā€™s University Belfast Leadership Team to their Antrim based headquarters, Randox Science Park on Tuesday, October 4th.

President and Vice Chancellor, Sir Ian Greer of Queenā€™s University was joined by Deputy Vice-Chancellor Professor Stuart Elborn, Head of Careers, Employability and Skills Mr Trevor Johnston, Head of Business Alliance Mr Dermot Leonard, Business Engagement Manager Mrs Joanne Mallon, Executive Director of the Global Innovation Institute Dr. David Quinn, Lead of Queenā€™s sustainable energy research Professor David Rooney, Dean of Research in Medicine, Health and Life Sciences Professor David Rooney, Dean of Research in Medicine, Health and, Life Sciences Professor Chris Scott, and Dean of Impact and Innovation in Medicine, Health, and Life Sciences.

The team received a presentation on Randoxā€™s capabilities which stimulated multiple discussions in relation to research, improvements in healthcare provision, skills and the exciting future of Life and Health Sciences in Northern Ireland.

The purpose-built facilities at the site, covering research and development, engineering, manufacturing and accredited laboratories provides an unparalleled depth of diagnostic capability within a single site.

Randox employ over 2,200 staff, including 800 research scientists and engineers ā€“ all focused on improving life science diagnostic capabilities globally.

More than 5% of the worldā€™s population (over 400 million people) receive medical diagnosis using Randox products each year.Ā Randox have major facilities in the UK, Ireland, India, and the United States, supported by global distribution and supply networks.

 


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