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[Prime] A new immunochemistry platform for a guideline-compliant cardiac troponin T assay at the poi


Abstract:

Background:

A multitude of troponin assays for the point-of-care (POC) have been developed showing a lack of analytical sensitivity and precision. We present a new platform solution for the high-sensitivity detection of cardiac troponin T (cTnT) in a 30 μL whole blood sample with a turnaround time of 11 min.

Methods:

The immunoassay was completely run in a ready-to-use plastic disposable, a centrifugal microfluidic disc with fully integrated reagents. After the sample application, the assay was automatically processed by separating the cellular blood components via centrifugation, followed by incubation of a defined volume from the generated plasma with the immunoreagents. The fluorescence in the signal zone of a membrane was measured after its washing for the cTnT quantitation.

Results:

A calibration curve, measured in whole blood samples spiked with native human cTnT, was generated covering a range up to a concentration of approximately 8300 ng/L. The lower detection limit was determined to be 3.0 ng/L. At a concentration of 14 ng/L, the 99th percentile value from the high-sensitivity cardiac troponin T (hs-cTnT) assay in the Elecsys® system, the imprecision (CV) was 3.8%. A CV profile indicated that the functional sensitivity for a CV <10% was 6.8 ng/L. The assay did not show any significant cross-reaction with human skeletal troponin T. We observed an excellent correlation with the hs-TnT Elecsys® assay for 49 clinical plasma samples (r=0.9744).

Conclusions:

The described technology shows that an analytical performance for a highly sensitive determination of cTnT can be achieved in a POC setting.

Authors Lopez-Calle E , Espindola P , Spinke J , Lutz S , Nichtl A , Tgetgel A , Herbert N , Marcinowski M , Klepp J , Fischer T , Brueckner T , Boehm C , Keller T Source Clinical chemistry and laboratory medicine : 2017 Apr 04 pg Pub Type(s) Journal Article

Language eng

PubMed ID 28375843

Link:

https://www.unboundmedicine.com/medline/citation/28375843/A_new_immunochemistry_platform_for_a_guideline-compliant_cardiac_troponin_T_assay_at_the_point_of_care:_proof_of_principle.

#04072017 #pointofcare #immunochemistry #centrifugalmicrofluidics #detection

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