4 The diagnostic tests

4 The diagnostic tests

The interventions

ADVIA Centaur BRAHMS PCT assay

4.1 The ADVIA Centaur BRAHMS PCT assay (Siemens Healthcare Diagnostics) is an automated chemiluminescent assay for the determination of procalcitonin in human serum and plasma. The assay principle combines a sandwich immunoassay with the detection of light emission as the final step. It is for use with the ADVIA Centaur/XP and ADVIA Centaur CP analysers. It has a measuring range of 0.02 to 75 nanograms per millilitre, a functional sensitivity of less than 0.05 nanograms per millilitre and an analytical sensitivity of less than 0.02 nanograms per millilitre. The time to result is 26 to 29 minutes, depending on the selected analyser.

BRAHMS PCT Sensitive Kryptor assay

4.2 The BRAHMS PCT Sensitive Kryptor assay (Thermo Fisher Scientific) is an automated immunofluorescent sandwich assay for the determination of procalcitonin in human serum and plasma. The measurement principle is based on TRACE Technology (Time‑Resolved Amplified Cryptate Emission), which measures the signal that is emitted from an immunocomplex with time delay. It is for use with the BRAHMS Kryptor, BRAHMS Kryptor compact and BRAHMS Kryptor compact PLUS analysers. The assay has a measuring range of 0.02 to 5000 nanograms per millilitre, a functional assay sensitivity of 0.06 nanograms per millilitre, and an analytical sensitivity of 0.02 nanograms per millilitre. The time to result is 19 minutes.

Elecsys BRAHMS PCT assay

4.3 The Elecsys BRAHMS PCT assay (Roche Diagnostics) is an automated electrochemiluminescent immunoassay for the determination of procalcitonin in human serum and plasma. The assay principle combines a sandwich immunoassay with the detection of light emission by a photomultiplier. The assay is for use on the Elecsys, Modular and Cobas e analysers. It has a measuring range of 0.02 to 100 nanograms per millilitre, a functional sensitivity of 0.06 nanograms per millilitre and an analytical sensitivity of less than 0.02 nanograms per millilitre. The time to result is 18 minutes.

LIAISON BRAHMS PCT assay

4.4 The LIAISON BRAHMS PCT assay (DiaSorin) is a sandwich chemiluminescent immunoassay for the determination of procalcitonin in human serum and plasma. The assay principle combines a sandwich immunoassay with the detection of light emission by a photomultiplier. The assay is for use with the LIAISON analyser. It has a measuring range of 0.1 to 500 nanograms per millilitre, a functional sensitivity of less than 0.24 nanograms per millilitre and an analytical sensitivity of less than 0.03 nanograms per millilitre.

VIDAS BRAHMS PCT assay

4.5 The VIDAS BRAHMS PCT assay (bioMerieux UK) is an automated enzyme‑linked fluorescent assay for the determination of procalcitonin in human serum and plasma. The assay principle combines a sandwich immunoassay with a final fluorescent detection. It is used with the VIDAS and miniVIDAS analysers. It has a measuring range of 0.05 to 200 nanograms per millilitre, a functional detection limit of 0.09 nanograms per millilitre and an analytical detection limit of 0.05 nanograms per millilitre. The time to result is 20 minutes.

The comparator

4.6 The comparator used in this assessment is treatment decisions based on standard clinical practice without procalcitonin testing.

  • National Institute for Health and Care Excellence (NICE)