4 The diagnostic tests

The intervention(s)

Elecsys Troponin T high‑sensitive assay

4.1 The Elecsys Troponin T high‑sensitive assay (Roche Diagnostics) is designed for use in a laboratory setting and can be used on the Roche Elecsys 2010 analyser and the cobas Modular Analytics e‑series immunoassay analysers. The Elecsys test is a sandwich electrochemiluminescence immunoassay, and is intended for the in vitro quantitative determination of troponin T in serum and plasma samples. The Elecsys Troponin T high‑sensitive assay has an estimated turnaround time of 18 minutes. The manufacturer states that the Elecsys assay can detect troponin T in 61% of the reference population and has a recommended 99th percentile cut off of 14 nanograms/litre, with a coefficient of variation or imprecision of less than 10%. The assay is CE‑marked and available to the NHS. The Elecsys Troponin T high‑sensitive assay is also available as a STAT version, which has a shorter turnaround time of 9 minutes.

ARCHITECT STAT High Sensitive Troponin‑I assay

4.2 The ARCHITECT STAT High Sensitive Troponin‑I assay (Abbott Diagnostics) is designed for use in a laboratory setting and can be used with the Abbott ARCHITECT i2000SR and i1000SR analysers. The assay is a chemiluminescent microparticle immunoassay and is intended for the in vitro quantitative determination of cardiac troponin I in serum and plasma samples. Results are available within 16 minutes. The manufacturer states that the ARCHITECT STAT High Sensitive Troponin‑I assay can detect troponin I in 96% of the reference population, and has a recommended 99th percentile cut‑off of 26.2 nanograms/litre, with a coefficient of variation of 4%. The manufacturer's instructions for use also states a 99th percentile cut‑off of 34.2 nanograms/litre for men and 15.6 nanograms/litre for women. The assay is CE‑marked and available to the NHS.

AccuTnI+3 troponin I assay

4.3 The AccuTnI+3 troponin I assay (Beckman Coulter) is designed for use in a laboratory setting with the Beckman Coulter Access II and UniCel DxI analysers. The AccuTnI+3 assay is a paramagnetic particle chemiluminescent immunoassay, and is intended for the in vitro quantitative determination of cardiac troponin I in serum and plasma samples. The assay is designed to be run as a STAT test and results are available within 13 minutes. The manufacturer states that the AccuTnI+3 troponin I assay has a recommended 99th percentile cut‑off of 40 nanograms/litre, with a coefficient of variation of 10%. Details of the performance of the assay in the reference population are currently considered as academic in confidence information by the manufacturer. The assay is CE‑marked and available to the NHS.

The comparator: standard troponin

4.4 The comparator used in this assessment is standard troponin testing over 10–12 hours.

  • National Institute for Health and Care Excellence (NICE)