ISO 22870:2006 in the Point-of-Care Testing (POCT) Market
ISO 22870:2006 in the Point-of-Care Testing (POCT) Market
Point-of-Care Testing (POCT)
The Point-of-Care testing market, better known as POCT, is growing rapidly as the demand for faster patient testing increases. This point is fully backed up through the results of the recent BIVDA (British IN-Vitro Diagnostics Association) survey of 2016. This survey focuses primarily on Point-of-Care Testing and there were a few questions asked that sparked an interest amongst us. The questions can be seen below;
“What are the challenges you face regarding POCT?”
“What do you see in the future for POCT?” (BIVDA, 2016)
Although many answers were put forward there was one (answer) that appeared for both questions. Accreditation. We found this intriguing yet far from surprising. POCT and accreditation go hand-in-hand, with laboratories striving to achieve ISO accreditation with the ultimate aim of allowing patients to have peace of mind that they are being tested properly and effectively.
ISO 22870:2006
The ISO standard that relates to POCT is ISO 22870:2006 Point of Care Testing- Requirements for quality and competence. This standard gives specific requirements applicable to POCT testing and apply when POCT is carried out in a hospital, clinic or a healthcare organisation providing ambulatory care. However, it is important to note and remember that ISO 22870 is not to be seen as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 (medical laboratories – particular requirements for quality & competence).
With accreditation in POCT becoming a major factor to laboratories, it is no surprise to see accreditation as one of the top answers to the two questions asked in the survey.
For laboratories looking to participate in point-of-care testing there are other factors of ISO 22870 that they must be aware of, one of the major factors is as follows;
“ISO 22870:2006 advises that where available, Internal Quality Control and participation in an External Quality Assessment (EQA) scheme is required in the point-of-care setting.”
How can Randox help?
Fortunately for laboratories, Randox are able to help out here. With a vast range of true third party controls and 32 comprehensive RIQAS (EQA) programmes, Randox can aid laboratories as they aim for ISO accreditation.
We have multiple products particularly suited to the POCT market including, Liquid Cardiac, Blood Gas and Urinalysis. These products are available both as internal quality controls and as EQA programmes.
Our Acusera range of true third party controls are conveniently supplied liquid ready-to-use, therefore requiring no preparation. This is a particular advantage in the POC environment were test results are required quickly and also were testing is not always performed by laboratory personnel. Supplied with assayed target values and manufactured from 100% human material, ensuring they act in the same manner as a patient sample, our Acusera controls are ideal for use at the point of care and will therefore aid a laboratory in gaining ISO accreditation.
Similarly, participation in our RIQAS EQA programme will also assist laboratories to meet regulatory requirements and achieve ISO accreditation. With over 40,000 laboratory participants in 123 countries, RIQAS is the largest international EQA scheme worldwide! Our Liquid Cardiac, Blood Gas and Urinalysis programmes are all supplied liquid ready-to-use, complementing their Acusera counterparts perfectly!
By using our Acusera controls and RIQAS EQA programmes side by side, a laboratory can confidently aim for ISO accreditation in the knowledge that they are meeting criteria.
Microalbumin shifts when changing reagent batch
A laboratory running a competitors 3rd party Microalbumin QC noticed shifts in their QC values whenever they changed reagent batch.
They tested two levels of quality control over three different batches of reagent the results can be seen in the table below.
| Competitor Control – Microalbumin | ||
| Reagent Batch |
QC Level One |
QC Level Two |
| 1 | 19.9 | 81.0 |
| 2 | 29.7 | 90.5 |
| 3 | 50.4 | 122.4 |
As can be seen from the findings above, Microalbumin results shifted significantly each time they changed reagent batch. This was the case for both the level one and level two control however when the lab tested the same set of patient samples across the three reagent batches results were consistent and did not show the same shifts.
The laboratory decided to contact Randox and ask about our Microalbumin controls. They were concerned about the shifts seen with their current supplier and highlighted the fact they were no longer confident in the results they were releasing. This led to them trialling the Randox liquid ready-to-use Microalbumin control with the same three reagent batches they tested previously.
Having tested two levels of the Randox quality control over the same three reagent batches the laboratory reported to us that their results were back on track and they were delighted with the outcome! The results of the Randox control can be seen in the table below.
| Randox Control – Microalbumin | ||
| Reagent Batch |
QC Level One |
QC Level Two |
| 1 | 33.5 | 158.8 |
| 2 | 34.9 | 164.9 |
| 3 | 34.8 | 168.0 |
The difference seen with the Randox control across the three reagent batches was much smaller than that of their previous control and was in line with the changes seen with their patient samples.
This case study highlights the commutability of the Randox QC range. By using a control with a matrix that reacts to the test system in the same manner as the patient sample the laboratory was confident in the patient test results produced and were able to meet ISO 15189:2012 requirements.
Serving Up Accurate Test Results
Today, June 27th, sees the beginning of one of the four tennis majors – Wimbledon. Basking in the summer sun while lying on ‘Henman Hill’, this yearly tournament attracts spectators from all over the globe who want to watch the world’s best tennis players ply their skills on the revered centre court over the course of a two week period. But what exactly is the most important skill a tennis player can utilise? Well, many players have different strengths but the one skill that all of them must possess is the ability to serve – and accurately.
The ability to serve is vitally important as it allows the point to begin, serving accurately however allows the player to set the pace and ensure they are on the front foot. By making sure they serve more accurately, the player can be confident in their ability to win the point and the match.
Just like tennis, laboratories will aim to be accurate when ‘serving’ up their test results. Achieving accurate test results is what every lab strives for. With patient results on the line it is important for labs to use QC material that will assist them in obtaining the correct results, therefore keeping them clear of causing a ‘racquet’.
Randox Acusera is world renowned for delivering unbiased performance assessment. Our range of true third party controls are manufactured to the highest standard ensuring commutable samples that react to the test system in the same manner as a patient sample, ultimately allowing labs to be confident in the results they produce. Much like the serve in tennis that needs to fall within a target area, QC results should be as close as possible to the target and ideally should fall within +/- 2 SD from the mean. By falling within these limits a lab can be sure of accurate results and an acceptable performance.
Employ Acusera quality controls in your laboratory today and experience unrivaled confidence in your test results.
Get your slice of our control range here by contacting us at acusera@randox.com. We guarantee you will love us!
Liquid CSF Quality Control
Providing a true third party solution for the measurement of Cerebrospinal Fluid (CSF), the Acusera Liquid CSF Control is designed to deliver an unbiased, independent assessment of analytical performance for 14 analytes, helping to ensure the results clinical laboratories release are accurate and reliable.
With an extended open vial stability of 30 days at 2oC – 8oC, the Acusera Liquid CSF Control will reduce waste, while remaining easy and convenient to use.
Features & Benefits
- Liquid ready-to-use samples requiring no preparation
- Human based material
- True third party control providing unbiased performance assessment
- Assayed target values available
- Shelf life of 2 years from the date of manufacture
- Open vial stability of 30 days for all analytes when stored at 2oC to 8oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Liquid CSF Control Level 1 | 10 x 3ml | 14 | CF10138 | |
| Liquid CSF Control Level 2 | 10 x 3ml | 14 | CF10139 | |
Analytes
- Albumin
- Albumin (electrophoresis)*
- Alpha – 1- globulin (electrophoresis)*
- Alpha – 2- globulin (electrophoresis)*
- Beta- globulin (electrophoresis)*
- Chloride
- Gamma – globulin (electrophoresis)*
- Glucose
- hsIgA*
- hsIgG
- hsIgM*
- Lactate
- Protein (Total)
- Sodium
*No claims are made regarding values and stability.
PTH Quality Control
Providing a true third party solution for the measurement of Intact PTH, the new Acusera PTH Control will deliver an unbiased,
independent assessment of analytical performance with any instrument or method.
This notoriously unstable marker, present in a number of immunoassay controls, is now available in a liquid frozen format with an impressive 30 day open vial stability, reducing waste while remaining easy-to-use.
Features & Benefits
- Liquid Frozen
- 100% human serum
- Assayed target values available for many immunoassay platforms
- Stable to expiry date at -20°C to 70°C
- Open vial stability of 30 days at 2°C to 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| PTH Control Level 1 | 3 x 3 ml | 1 | PTH10110 | |
| PTH Control Level 2 | 3 x 3 ml | 1 | PTH10111 | |
| PTH Control Level 3 | 3 x 3 ml | 1 | PTH10112 | |
Analytes
- Intact PTH (Parathyroid Hormone)
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Evidence Immunoassay Control
Multi-analyte immunoassay control designed for use in the routine monitoring of the Randox Fertility, Thyroid and Tumour Marker Arrays.
Features & Benefits
- Lyophilised for enhanced stability
- Assayed values available for Randox Biochip systems
- 100% human serum
- Stable to expiry date at 2oC – 8oC
- Reconstituted stability of 7 days at 2oC – 8oC or 4 weeks at -20oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Evidence Immunoassay Control | 4 x 3 x 5ml | 14 | EV3570 | |
Analytes
- CEA
- Estradiol
- FSH
- Free T4
- Free T3
- Leutinising Hormone
- Prolactin
- Progesterone
- PSA (Total)
- PSA (Free)
- Testosterone
- Total T4
- Total T3
- TSH
CYFRA 21-1 External Quality Assessment
The RIQAS CYFRA 21-1 EQA programme is designed to cover the analysis of CYFRA 21-1 in clinical laboratories when monitoring the response to treatment of cancers such as non-small cell lung carcinoma, cervical, breast and bladder cancer.
- Lyophilised samples
- Monthly reporting
- Testing covers the full range of clinically relevant decision levels
- Submit results and view reports online via RIQAS.net
- 12 month subscription
- Cycle Starts – March 2025
| Cat No | Kit Size | Frequency | Parameters | |
|---|---|---|---|---|
| RQ9175 | 12 x 1ml | Monthly | 1 | |
Parameter
- CYFRA 21-1 (Cytokeratin 19 fragment)
Please note, product availability may vary country to country.
Related Products
Anti-TSH Receptor External Quality Assessment
The RIQAS Anti-TSH Receptor EQA programme is designed to cover the analysis of Anti-TSH Receptor in clinical laboratories when thyroid dysfunction is suspected.
- Lyophilised samples
- Monthly reporting
- Testing covers the full range of clinically relevant decision levels
- Submit results and view reports online via RIQAS.net
- 12 month subscription
- Cycle Starts – March 2025
| Cat No | Kit Size | Frequency | Parameters | |
|---|---|---|---|---|
| RQ9174 | 12 x 1ml | Monthly | 1 | |
Parameter
- Anti-TSH Receptor (TRAb)
Please note, product availability may vary country to country.
Related Products
Immunosuppressant External Quality Assessment
The RIQAS Immunosuppressant EQA programme has been designed to cover the analysis of Immunosuppressants in clinical laboratories. Immunosuppressants are primarily used after transplant operations to prevent the host body from rejecting donor organs.
- Lyophilised samples
- Monthly reporting
- Testing covers the full range of clinically relevant decision levels
- Submit results and view reports online via RIQAS.net
- 12 month subscription
- LC/MS reference values provided enabling participants to compare results to an accurately assigned value
- Cycle Starts – March 2025
| Cat No | Kit Size | Frequency | Parameters | |
|---|---|---|---|---|
| RQ9159 | 12 x 2ml | Monthly (1 x 12 month cycle) | 4 | |
Parameters
- Ciclosporin
- Everolimus
- Sirolimus
- Tacrolimus
Please note, product availability may vary country to country.
Related Products
Sweat Testing External Quality Assessment
The RIQAS Sweat Testing EQA programme has been designed to cover the analysis of Sweat Testing in clinical laboratories measuring the concentration of Chloride and Conductivity in sweat, used in the testing of Cystic Fibrosis (CF).
- Liquid ready-to-use samples
- Monthly reporting
- Testing covers the full range of clinically relevant decision levels
- Submit results and view reports online via RIQAS.net
- 12 month subscription
- Cycle Starts – March 2025
| Cat No | Kit Size | Frequency | Parameters | |
|---|---|---|---|---|
| RQ9173 | 12 x 2ml | Monthly | 2 | |
Parameter
- Chloride
- Conductivity
Please note, product availability may vary country to country.