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Cerba Healthcare Belgium, afdeling CRI

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Abstract Bachelor Project 2017-2018: Validation of fecal markers on the ThunderBolt® Analyzer

Preventive healthcare has become more important in recent years.That is why CRI has partnered  with biopredix to give patients more inside into  intestinal health.

This can be done by doing a gut screening withs includes measuring secretory IgA, beta-defencine, zonulin, pancreatic elastase, ... These parameters are still measured manually now and are really labor-intensive. Therefore CRI decided to try to automate them on the ThunderBolt® Analyzer. Before this transition can be completed,  A  validation process needed to be conducted on the different parameters. This was done by using fecal samples collected from apparently heathy volunteers. These were aliquoted and measured on the ThunderBolt® Analyzer. At the same time also samples with a known concentration were measured. The results were then processed on Excel by using a  four parameter fit curve.

For some of the parameters additional tests need to be conducted to find a working protocol to validate them completely.

Abstract bachelorproef 2016-2017: Validation of the new test active B12 and a new generation of reagent for anti-HBs on Architect i2000SR

Active vitamin B12 is a new parameter that will be determined in the lab. For the determination of anti-HBs there is a new generation of reagent. Since CRI is ISO15189 accredited, validation must be performed in these cases. Anti-HBs is an already existing test performed on the Architect i2000SR from Abbott. Active B12 will also be performed on the Architect i2000SR.

The determination of active B12 can be useful since the determination of total B12 doesn’t always detect a deficiency. The highest amount of total B12 is biologically inactive and can mask a low level of active B12. Patients will miss their diagnosis when only total B12 is determined. That’s why CRI has decided to implement the determination of active B12.
A healthcare provider or a medical laboratory worker must be immune to the hepatitis B virus. Therefore, the anti-HBs titer is determined. The determination of anti-HBs can also be useful for patients with hepatitis B. When the antibodies can be detected in blood, the infection with the virus is over.

For both validations the precision and accuracy will be determined with the 5x4 method. Also the limit of quantification will be verified for both tests. For anti-HBs a cross validation will be performed between the current generation and the new generation of reagent. The results will be evaluated using a Bland and Altman plot and Passing Bablok regression. For active B12 the reference ranges and stability in the fridge will be verified. The last validation test is making a dilution series to verify the linearity of the calibration curve.

Both parameters are precise and accurate according to the criteria of Abbott and the European Medicines Agancy (EMEA). Both limits of quantification are accepted according to Abbott and EMEA. The cross validation has shown that there is a systematic and proportional error on the new generation of reagent for the determination of anti-HBs. The reference ranges for active B12 are accepted according to Clinical & Labaratory Standards Institute. Active B12 was shown to be stable for four days in the fridge. Finaly, the calibration curves of both tests were shown to be linear.

Based on the findings of the validations, active B12 will be implemented in the laboratory. Additional validation is required for anti-HBs since the new generation reagent is not transparent with the current generation.

Abstract bachelorproef 2015-2016: Validatie van STA-R MAX® Stago analysers voor routine coagulatie parameters

Quality assurance has become the most important metric in routine laboratory practice in recent years. Therefore CRI decided, in their continuous pursuit of excellence, to replace their current coagulation analyzer STA-R Evolution in favor of the next-generation STA-R MAX®.

Before the transition process can be completed a validation protocol to ensure STA-R MAX® performance will be executed. At the start of the study it is known that STA-R Evolution® performs correctly and was therefore used as a reference instrument for this study. This validation will evaluate two STA-R MAX® analyzers by comparing results with the current STA-R Evolution®.

Measurements are conducted using the same samples under the same conditions. Coagulation parameters tested are Protrombine Time (PT), Activated Partial Trombine Time (aPTT), Fibrinogen (FBG) and D-Dimer (D-Di). To test STA-R MAX® ability for accurate analysis, a series of measurements are made from samples for each of the four parameters. The results of these measurements allow calculation of the precision, bias and allowable total error of the instrument. Additional tests are conducted to observe STA-R MAX® ability to detect and measure different samples under various conditions such as Carry-over and Cap-piercing.

Clinical measurement differences between STA-R MAX® and STA-R Evolution® are validated according to criteria of Ricos and the STA-R series manufacturer STAGO. Validation results for STA-R MAX® are shown to be acceptable. Evaluating these results CRI decides to implement STA-R MAX®in favor of its predecessor STA-R Evolution®.  

Address

Industriepark Zwijnaarde 3
9052 Zwijnaarde
Belgium

Contacts

Traineeship supervisor
Christine Vanlaere
Traineeship supervisor
Joachim Vandroemme
Sarah De Baets
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