Medical Laboratory Professionals Week 2024
Medical Laboratory Professionals Week 2024
Medical Laboratory Professionals Week (MLPW) is recognised every year in the last full week of April. It’s an opportunity to increase the public understanding of, and appreciation for, the hard work of clinical laboratory staff around the world. It’s also an opportunity to inject a little fun into the laboratory. So, this year, we’ve created a Lab Professionals QC Bingo card. Have a go and see how many your laboratory can get!
How many boxes does your lab tick?
If you’re calling Bingo! you must be an Acusera 24.7 customer. If not, keep reading to find out how you can make daily life in your laboratory more straightforward.
What are Medical Laboratory Professionals?
Medicine wouldn’t be where it is today without the work of these laboratory professionals. They’re on the frontline. Around 70% of medical decisions are based on results provided by medical laboratory staff. That’s a lot of pressure on the labs to make sure their results are accurate. Clinical laboratory staff not only perform the tests used to guide diagnosis and disease prevention, but they also check all the tests they use through rigorous quality control (QC) procedures.
This involves testing samples of known values to prove that the test system and its components perform as they should and provide accurate results. To do this, laboratories require QC material. It’s important that what’s in a QC is as similar to what you’d find in a patient sample as possible. This is known as commutability. Good commutability helps limit cross-reactivity in the test and inaccurate results.
It’s also important to make sure the QC material has concentrations of analytes at similar values to those used to make diagnostic decisions. If you wanted to validate the length of the ruler on your desk, it wouldn’t be helpful to set it down on a 100m running track. Similarly, when laboratory professionals want to ensure a test is producing accurate results, they want to test the system at the critical values used to make medical decisions so that they can be confident the results at these values are accurate.
Once lab staff have confirmed the accuracy of their tests, they can begin testing patient samples. For most people, what happens to a sample after it’s taken is a bit of a mystery. MLPW is the perfect opportunity to unravel this a little:
After your sample is collected, it gets sent over to the lab. Even just moving it there needs careful handling to make sure it’s still good for testing when it arrives. Once it’s in the lab, the team checks the equipment to make sure it’s working right and giving accurate results. The QC procedure varies depending on what they’re testing for, but they always make sure their tests are legitimate. Once they’ve checked everything and carried out the tests, a pathologist looks at the results to figure out what’s going on. They use this information to help decide on the best treatment plan for you.
Even this watered-down explanation makes it sound like a lot of work, right? At Randox, we recognise the vital role and dedicated efforts of medical laboratory professionals, and the invaluable contributions they make to society, and we hope that now, you do too.
Acusera 24.7
Bingo! That’s exactly how our customers feel when they realise how much time Acusera 24.7 can save them. Our innovative and intuitive QC data software is cloud-based, allowing you to log in from anywhere in the world to review your QC data.
Along with a wide range of interactive charts, including Levey-Jennings charts, Acusera 24.7 determines measurement uncertainty and sigma metrics for you, saving you the time and stress of manually calculating these tricky statistical analyses. And that’s just the beginning. Acusera 24.7 can link to LIMS for automated data entry, meaning lab staff don’t have to manual type long datasets, unless they want to of course; we also provide both semi-automated data upload and manual data entry options.
Access to a range of reports has never been easier. Acusera 24.7 is particularly useful when gaining or renewing your accreditation, and live peer group QC data, to give additional confidence in the accuracy of your results.
But this article is supposed to be about laboratory professionals, so we won’t bang on about it anymore. We just want everyone to know about Acusera 24.7 so they can get that daily bingo! feeling for themselves. If you want to learn more about our reports, charts, advanced statistical analysis, Acusera 24.7 more generally, or how Acusera 24.7 can help you achieve your accreditation, you can follow the links to the relevant blog post.
Last year, we interviewed two of our laboratory staff, Dean and Meadhbh, to find out what a normal day looked like for them. To find out what a day in the life of a laboratory professional is like, take a look at the interviews here
If you’d like to get in touch with us to discuss the advantages of Acusera 24.7, or you’ve made up your mind and want to get in on the action, reach out to us at marketing@randox.com. We’re always happy to brag about how great Acusera 24.7 is, and how we make life simpler for more and more laboratories every day.
RIQAS Performance Assessment – Z Score vs SDI
Z Score vs SDI
You work hard to implement top class quality control in all areas of your laboratory. The success of your labours is reported to you through your External Quality Assessment (EQA) results. It can be frustrating when your report is returned, only for you to find that you’ve been assigned a poor performance score due to other laboratories in your participation group.
At RIQAS, we want your EQA results to reflect your performance, not that of everyone else, to truly illustrate the efficacy of your quality control procedures. This is why, instead of Z scores, we report your performance in terms of a Standard Deviation Index (SDI). However, we know that in some countries, you’re required to report a Z score. Don’t fret. You can still find this result in the .csv file provided with your report.
A Z score is a statistical measurement that describes a value’s relationship to the mean of a group of values. In other words, it’s a value calculated to tell us how many standard deviations (SDs) a result is from the expected mean. Z score is reported in terms of SD’s, therefore a Z score of 0 shows the result is identical to the mean.
While useful in many cases, when used in EQA, a Z score can give a false perception of performance. We want RIQAS participant performance assessment to be based on their individual performance, rather than being impacted by how well, or poorly, the other laboratories in the group performed for a sample.
Z score is calculated using a variable SD. This means that as results are added, the mean and SD can change. For example, if overall performance for a sample improves, the CV associated with the data will decrease, causing an increase in Z score. Let’s take a quick look at how RIQAS performance assessment works, and then we can get into SDI.
RIQAS Performance Assessment.
Our target scoring system has been developed to provide a simple interpretation of your laboratory’s performance. To calculate a target score, your result is calculated as a percentage deviation (V) from the Mean for Comparison. This deviation is then compared to a Target Deviation for Performance Assessment (TDPA) to calculate the Target Score.
The difference between your result and the mean for comparison is expressed as a Target Score (TS) using the following mathematical formulae:
The better your percentage deviation compared to the TDPA, the higher your Target Score will be.
TDPA are set to encourage participants to achieve and maintain acceptable performance. Target Deviations are assigned to be fit-for-purpose and take all possible sources of variation into account, including sample homogeneity and stability as per ISO/IEC17043, ISO13528 and IUPAC.
In general, the TDPA is set so that ~10% laboratories achieve Target Scores less than 50. However, depending on homogeneity and stability, the TDPAs may be adjusted, so that participants’ performance is not adversely affected by sample variability. If your % deviation (V) is equal to the Target Deviation for Performance Assessment (TDPA) then a target score of 50 is achieved.
RIQAS reviews TDPAs annually and the methods used to assign them have been agreed by the RIQAS Advisory Panel.
Standard Deviation Index (SDI)
To provide a more accurate assessment of performance, we use SDI instead of Z score. SDI is a score which compares the participant’s difference from the assigned value (mean for comparison) with an evaluation interval called the Standard Deviation for Performance Assessment (SDPA).
The SDPA calculation involves a series of steps. First, we calculate a CV for Performance assessment (CVPA) as shown below:
As mentioned, the TPDA is normally set so that ~10% of laboratories achieve a TS less than 50. In such cases, the t-value used to convert TDPA to CVPA is ~1.645. However, depending on homogeneity and stability, the TDPA may need be increased, so that participants’ performance is not adversely affected by sample variability. In such cases less than 10% of laboratories will have poor performance, and a larger t-value will be chosen to convert TDPA to CVPA
We then convert CVPA to SDPA:
Using this equation, an initial SDPA is calculated for every mean for comparison (i.e. for all methods, method, and instrument statistics). However, for new parameters or those which have small participation numbers, it’s not always possible to assign a target deviation, TDPA or SDPA. In such cases, the SDPA will be the SD calculated when the mean for comparisons is generated.
According to ISO/IEC17043, when the assigned value is based on consensus (mean for comparison), the uncertainty of the assigned value must be calculated and combined with the SDPA when it is considered to be significant. This forms an adjusted SDPA, which is used to calculate the participant’s performance in terms of SDI.
Using the SDPAadjusted we can calculate SDI using the formula below:
On your RIQAS report, you’ll find the SDI associated with the current sample in the text section of each report page. We also provide your last 20 SDIs, plotted on a Levey-Jennings chart, along with an indication of the mean for comparison for each sample (I = Instrument group, M = Method group, or A = All Methods group). Acceptable performance is an SDI of less than ± 2.
RIQAS EQA
RIQAS is the world’s largest EQA scheme with more than 75,000 laboratory participants spanning over 138 countries. Choosing an EQA provider is no easy task. That’s why we’ve produce a guide to help you find the right one for you. You can download it here.
At RIQAS, we’re always coming up with new ways to make your performance assessment and result interpretation even easier. We’re also proud of our new programmes and pilot schemes. This year, we’re running pilot programmes for Anti-psychotic drugs, Chagas and Blood Typing.
If you’d like to find out more about the range of programmes we provide, visit our website or download our brochure. Alternatively, you can get in touch with us at marketing@randox.com.
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.
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
- 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
- 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
- Karrar SA, Hong PL. Preeclampsia. StatPearls Publishing; 2023.
- 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
- Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia. Circ Res. 2019;124(7):1094-1112. doi:10.1161/CIRCRESAHA.118.313276
- 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
- NHS. Pre-eclampsia. Health A to Z. Published September 28, 2021. Accessed January 3, 2024. https://www.nhs.uk/conditions/pre-eclampsia/complications/
- Magley M, Hinson MR. Eclampsia. StatPearls Publishing; 2023.
- 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
- Costello RA, Nehring SM. Disseminated Intravascular Coagulation. StatPearls Publishing; 2023.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
RIQAS Point of Care EQA
Designed to improve the quality of Point of Care Testing (POCT) in locations such as pharmacies, GP surgeries, hospital out patient departments, sports clinics, supermarkets, diagnostic/treatment and walk-in centres.
RIQAS Point of Care EQA provides independent evidence of the accuracy and reliability of test results.
Why RIQAS Point of Care?
Programme Offering
Tests
Role
Matrix
Lipids (Total Cholesterol & HDL Cholesterol)*
- Risk Factor for heart Disease
- Monitoring lipid lowering therapy
Whole Blood
HbA1c (Glycated Hemoglobin)*
- Diagnosing diabetes mellitus
- Monitoring treatment
- Encouraging self-management
Whole Blood
CRP (C Reactive Protein)*
- Early detection of infectious disease
- Identifying need for antibiotic treatment
Whole Blood
Glucose / Ketones
- Diagnose and monitor diabetes
- Monitor the presence of hypoglycemia (low blood glucose) and hyperglycemia (high blood glucose)
- To determine whether excessive ketones are present in the blood, to detect diabetic ketoacidosis (DKA)
Serum
International Normalised Ratio (INR)
- Used to measure the effect of anticoagulant drugs such as warfarin
- Help diagnose a bleeding disorder; to help estimate the severity of liver disease
Whole Blood
Key Cycle Dates
RQ9181 Distribution Month Sample Distributed Result Submission Deadline January 2024 8th January 17th January February 2024 5th February 14th February March 2024 4th March 13th March April 2024 2nd April 10th April May 2024 6th May 15th May June 2024 3rd June 12th June July 2024 1st July 10th July August 2024 5th August 14th August September 2024 2nd September 11th September October 2024 7th October 16th October November 2024 4th November 13th November December 2024 2nd December 11th December What Participants Say
What participants say
Our unrivalled commitment to quality and service ensures high levels of customer satisfaction, this is evident from the responses to our latest customer satisfaction survey:
“All in all a quick and efficient service”
“Good online system”
“Very helpful team”
“Excellent training”
“They are an experienced team”
“Very satisfied with the service that we receive”
“Very good value for money”
“The website is great”
The Importance of Quality Assurance
Importance of quality assurance
Quality assurance is an essential aspect of any clinical/diagnostic testing service and is aimed at ensuring the accuracy and reliability of patients’ results. The right result allows the right clinical advice to be offered in a timely manner. Quality assurance operates at two levels:Internal Quality Control
Internal Quality Control includes operator training/ competency assessment, analyser/ test system maintenance, and adherence to policies/ processes. Whilst some point of care analysers include inbuilt quality checks, cross-check analysis against samples with known levels provides immediate assurance and evidence that a patient’s result is safe to report.External Quality Assessment
External Quality Assessment involves analysis of samples with unknown levels that have been distributed by an external organisation. Participants are informed how their results compare with other participants, hence providing independent evidence of performance. Increasingly, participation in an external quality assessment scheme is becoming a mandatory requirement where health and healthcare services are being provided.
EQA provides assurance to both staff and customers that testing provides accurate and reliable results.
Want to know more?
Contact us or download the RIQAS Point of Care catalogue to learn more.
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Frequently Asked Questions
RIQAS
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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:
- It helps ensure the measured results are useful and not wildly inaccurate.
- It permits meaningful comparison of medical decision limits and previous results of the same kind in the same individual.
- 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.
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
Lyme Disease Control
Acusera | Lyme Disease Control
The Acusera Lyme Disease Control delivers a true third-party solution for the routine performance monitoring of Lyme Disease on most immunoassay analysers. All samples are conveniently supplied in a user-friendly, liquid ready-to-use format.
Lyme Disease is an infectious disease caused by the bacterium Borrelia burgdorferi and is spread by ticks.
Benefits
- Liquid ready-to-use requiring no preparation
- Human based plasma providing a matrix similar to the patient sample
- True third party control
- Open vial stability of 60 days at 2ºC to 8ºC
- Suitable for use with most immunoassay analysers
- CE marked controls
Click through below to learn more about each control.
Related Products
Acusera Controls
RIQAS EQA
Molecular IQC
Resource Hub
Effortless Data Management: Acusera 24.7 Reports
You’ve carried out your daily maintenance and run your IQC. You’ve got your results and now it’s time to type them up into one of your expansive spreadsheets. Reports
You’ve probably got your spreadsheet set up to calculate the required parameters already, but what if there’s an error in the formula? Or what if you make an error when entering your data? Or worse, what if you try to open the spreadsheet only to find that the file is corrupted or lost? If your Excel file is there, someone else might already be editing it, meaning you must wait until they’re finished before you can make any changes.
Even if you face none of these obstacles the labour-intensive statistics needed for performance review and validation might just keep you up at night.
Well, with Acusera 24.7, these concerns are history.
Whether you make use of our automated or semi-automated data entry options, you can be sure that the data put into the system is exactly that returned by your instrument. If you use the manual data entry option, we can’t remove the human error element – but with our simple and intuitive interface, we trust you’ll be flawless anyway. What’s more, the cloud-based nature of our software also means you won’t lose the data by mistake and unique access for each user allows multiple people to be logged in at the same time.
So, what next?
Well, you can view this data on our dashboard for fast and easy access to your results but delve a little deeper into Acusera 24.7 and you can access comprehensive, easy-to-read, customisable, reports designed to speed up the review process.
These reports include statistical analysis, exception reports, peer group statistics, uncertainty of measurement and advanced statistical metrics. The latter two we’ll look at in a dedicated article. For the others, however, let’s dive in and see how you could benefit from our range of extensive reports.
Statistical Analysis Reports
The first report we will look at is the statistical analysis report. This report allows you to view your IQC data from a specified date range, and compare it to your cumulative data, that is, all the IQC data you’ve collected since you began using that lot, as well as the peer group data for the same lot all within one screen. If you are part of a chain of laboratories, you can compare this data with your laboratory group to see how your lab stacks up by using the World/Group toggle button.
This report provides you with the count, mean, SD, CV, SDI and CVI for a lot and can be organised by assay, as shown in the image below, instrument, or method, allowing you full freedom to customise this report to suit your needs. Don’t forget, like all our reports and charts, this data is fully exportable to PDF or Excel for filing or data review.
Handy, right? This report provides you with everything you need to carry out the validation and verification of new IQC lots, plus much more. We’ll look at this in more detail in an upcoming article.
Exception Reports
If you wish to determine your best and worst-performing tests, our exception report is perfect for you. This report is designed to quickly and easily identify assays with a high percentage of errors. The exception report provides an on-screen summary of the number of QC results for each individual assay and control lot that fall within the following categories: <2SD, 2-3SD and >3SD. This comprehensive performance review can be filtered: by clicking on the top of the ‘>3DSI’ column, this report will display assays in descending order with your worst-performing assays at the top, as shown below.
Filtering by ‘<2SDI’, it will display the same data with your best-performing assays at the top.
With this information, you can determine in which of your assay’s failures most often occur and encourage staff to look a little more closely at why failures arise and identify changes to improve and minimise errors.
Peer Group Statistics Reports
Now that you have figured out the performance of your assays, you’ll want to see how you compare with others running the same tests. Our Peer Group Statistics Report is your new best friend.
Updated live and in real-time, with no submission deadlines, you can compare your statistics to those of your peer group, determined by analyte, method, instrument manufacturer and model.
Simply select the IQC lot you wish to analyse and Acusera 24.7 will generate the data for you, displaying the count of QC data, mean, SD and CV, giving you comprehensive insight into your performance vs your peers.
You can customise this report even further. If you select an analyte, we’ll show you the data for that analyte alone. If not, we’ll show you the information for all analytes related to that lot. The same goes for specifying a date range – if you choose a range, we’ll show you the data inside that range alone. If not, we’ll show you all the data for your chosen lot.
By clicking on the headers, you can filter the data – 1 click will display the data in ascending order, 2 will show you a list in descending order and 3 clicks will reset the table.
When these reports are combined with the other impressive features of Acusera 24.7, like our fully customisable charts or advanced statistical analysis, this software can help streamline your IQC procedure and data review process.
When the accreditors come knocking, others will be scuffling around trying to gather multitudes of reports and files, but you will be sitting with a smile on your face and your feet up, because you’ve got Acusera 24.7.
With full onboarding assistance and technical support that’s top-of-the-class, you’ll always have someone to help you get to the bottom of any problems that you face.
If you haven’t already booked a demo, get in touch with us today and let us show you how much time we can save you with this innovative and intuitive software. Alternatively, take a look at our Resource Hub for some material on Acusera 24.7 or Acusera IQC.
To streamline your QC Data analysis, get in touch with us at marketing@randox.com.
Charting the Course to Laboratory Excellence
Are you still using spreadsheets for your QC data and Charts?
You’ve been left behind.
But don’t worry!
Your laboratory’s ultimate ally in the quest for precision and excellence has arrived.
Acusera 24.7 is a tool that not only streamlines your QC data but also empowers you with a treasure trove of invaluable charts.
These charts are more than just numbers and lines; they are your secret weapon for troubleshooting, achieving accreditation, and driving continuous process improvement.
Acusera 24.7 doesn’t just offer charts. It offers a symphony of insights at your fingertips. From the precision of interactive Levey-Jennings charts to the competitive edge of performance summary charts for peer group comparison, from the rhythm of weekly mean charts to the clarity of reliable SD histograms – these charts are your compass in the world of quality control.
The best part?
You’re in control.
Tailor these charts to your unique needs, whether you’re dealing with single or multiple analytes, an abundance of QC lots, fixed or variable SDs, or need to pinpoint data within a specific date range.
Join us on a journey through the world of Acusera 24.7’s charts, where data becomes your strategic advantage, and discover why more laboratories are choosing Acusera 24.7 for QC data management every day.
Levey-Jennings Charts
Every laboratorian has seen countless Levey-Jennings charts and for good reason.
These charts are the unsung heroes of quality control in the laboratory.
They offer a visual snapshot of data over time, helping to detect trends, outliers, and systematic errors that might otherwise go unnoticed. Levey-Jennings charts are like the heartbeat monitor of your laboratory, providing real-time insights into the health of your analytical processes.
We’ve taken Levey-Jennings charts to the next level.
Our colourful graphs might look like they belong in a modern art museum, but trust me, they’re more than just eye candy.
Acusera 24.7’s Levey-Jennings charts are like the laboratory’s personal detective, sniffing out anomalies and shifts and making sure your QC data behaves.
Let’s have a look at what you can do with the Acusera 24.7 interactive Levey-Jennings charts.
The screenshot below shows a Levey-Jennings chart for a single analyte, with the date on the X-axis and SD on the Y-axis. On this chart, you can see data points displayed in different colours. Green data points indicate an acceptable result. Orange points show data that has triggered your predefined alert criteria, while red points are those that have broken your set rejection rules.
The lines marked on the chart below represent events that have been recorded. Instrument events such as calibration events or maintenance can be recorded to monitor their effects on your QC, allowing you to quickly see how these events relate to any deviations or improvements in your QC data. For example, after the event labelled ‘Reagent lot change’ you can see a series of alerts and failures. Marking this event on the chart allows for an at-a-glance explanation of this deviation. These events are completely customisable so you can record any relevant information you want!
Finally, data points that appear as a triangle indicate a comment has been added. What text is included in the comment is completely up to you!
The next screenshot below shows a Levey-Jennings chart containing QC data for all the tests included in the Clinical Chemistry Panel.
Acusera 24.7 panels allow you to group related tests together, helping increase the efficiency of your data review.
It looks great, right?
Maybe a little confusing.
The screenshot is perhaps a little deceptive.
When viewing these charts live, you can view the data as a whole, or home in on individual data sets by simply hovering over the data you want to see. You can also selected a deselect datasets at will by clicking on its name in the list below the chart.
The screenshot below shows an example of this.
All the charts we’ve looked at so far have had a fixed 3SD on the Y-axis.
For a more in-depth review of your data, you may wish to expand this axis.
With the click of a button, you can expand the Y-axis to include all your data points. See below for an example.
In some cases, you may wish to view this data displayed as ‘% Deviation’.
Again, with the click of a single button, you can convert the Y-axis to show just that, as shown below.
Performance Summary Charts
Peer group comparison of IQC data has a lot of benefits.
Comparing your data with other laboratories that use the same QC lot, instrument, method and more, can help you with troubleshooting and continuous process improvement.
The Acusera 24.7 Performance Summary Charts do all the work for you.
As shown in the screenshot below, these charts display your data and how it compares to your peers including mean, CV, and SD.
You can also view this data in a table to get a more detailed picture of your performance.
Like the Levey-Jennings charts, you can also combine this information for panels or a selection of multiple lots and analytes. You can see an example below:
Weekly Mean Charts
Weekly Mean Charts are one of the new features in our latest software release.
They allow you to view your weekly count of QC results for a specific instrument, assay, or lot.
Below is an example in a bar chart format.
You can also view this data as a line graph, which plots the weekly mean of results from multiple instruments using the same assay and QC lot, allowing a comprehensive overview of your QC data.
Or you can view your weekly means for a range of tests and panels.
Finally, the SD Histograms allow you to view the distribution of your results, for an overview of performance.
When used with Acusera 24.7’s suite of advanced statistical tools and reports, our charts can help you reduce the time you spend investigating non-conformances.
When the dreaded accreditation assessment approaches, you can relax. While others are scrambling to find documentation, you can rest assured that all the QC data you need is easily accessible.
Assessors love to see Acusera 24.7 load when they enter a laboratory because they understand how much easier QC management is when using our software.
We provide complete onboarding assistance and full training on the software for new customers while delivering prompt and effective customer support for existing users. The Acusera 24.7 and QC operations teams are always eager to help new and existing Acusera 24.7 users with any issues they experience.
To learn more about the features of this ground-breaking software, visit our website here.
Alternatively, feel free to reach out to us at marketing@randox.com for more information or to arrange a demo!
