Browsing Tag

new methodology

Advanced Technology Laboratory, Molecular Diagnostics

Methods update on BCR-ABL1 t[9;22] RT-PCR testing

An updated BCR-ABL1 t[9;22] RT-PCR assay went live on Jan 31, 2018. The BCR-ABL major and minor fusion transcripts are measured and reported separately after this update. The quantities of BCR-ABL1 major breakpoints fusion transcripts (type e13a2 and/or e14a2) are detected by FDA approved QuantideX® qPCR BCR-ABL IS Kit and the result is calibrated and reported on the International Scale (%IS). The quantities of BCR-ABL minor fusion transcripts are detected by QuantideX qPCR BCR-ABL minor kit and the result is reported as BCR-ABL1 to ABL1 ratio (%). This update provides more precise and standard measurements of BCR-ABL fusion RNA and supports the consistency of patient care in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

Questions may be directed to the Molecular Diagnostics Laboratory using the “Contact Us” link above.

Lab Catalog link: LAB3222022: BCR-ABL1 t[9;22] RT- PCR  

Immunochemistry

dsDNA Antibody Update

Effective March 20, 2017, Spectrum Health Regional Laboratory’s Immunology department will be switching dsDNA vendors from Varelisa ™ to ThermoFisher/Phadia ™.

Both manufacturers (mfr) have similar methods but different reference criteria presumably due to manufacturer specific dsDNA epitopes identified.

The interpretive cutoffs will be changing, please refer to the table below. Continue Reading

Chemistry, Immunochemistry

Growth Hormone Update

As of February 7, 2017  the method/instrument used for the  Growth Hormone assay performed at the Spectrum Health Regional Laboratory will be switched from ROCHE COBAS to the IDS- iSYS. A method comparison between the two methods showed excellent clinical and numerical comparability. The assay also performed excellently in terms of precision and linearity. Continue Reading

Microbiology, Test Utilization

Clostridium difficile Two-Step Algorithm Testing

Spectrum Health Regional Laboratory is preparing to switch Clostridium difficile testing methods from solely using a molecular approach to a 2-step algorithm utilizing an Enzyme Immunoassay (EIA) that detects two C. difficile-specific proteins (glutamate dehydrogenase or GDH, and A/B toxin) with indeterminant EIA specimens reflexed to PCR (see flowchart below). It is estimated that approximately 90% of patients tested will be resolved by EIA and not require reflexive PCR testing. This algorithm decreases expenses to the patient by an average of 65% as compared to current testing without sacrificing result quality. Specimens will be batched for EIA testing at a frequency to ensure that results are available within 6 hours of receipt by the laboratory so that proper contact isolation precautions may be initiated when indicated. Continue Reading