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Comparison of the Abbott Architect BRAHMS and the Biomérieux Vidas BRAHMS Procalcitonin Assays.
J Appl Lab Med 2019; 3(4):580-586JA

Abstract

BACKGROUND

Procalcitonin (PCT) is a well-established marker for bacterial infection. Recently the US Food and Drug Administration approved the expanded use of this biomarker to guide clinical decisions for antibiotic treatment in patients with lower respiratory tract infections. Both the Architect BRAHMS PCT (PCT-A) and Vidas BRAHMS PCT (PCT-V) are approved for this indication. The aim of this study is to evaluate analytical performance of PCT-A in comparison to PCT-V.

METHODS

PCT-A and PCT-V were evaluated for intra- and interassay precision and functional sensitivity. To assess the accuracy of PCT-A, 108 residual plasma specimens were randomly selected from routine hospital orders, and PCT was measured concurrently with PCT-A and PCT-V.

RESULTS

Both assays demonstrated excellent precision, with intraassay precision ranging from 2.2% to 4.0% CV and interassay precision ranging from 2.5% to 3.6% CV. The functional sensitivity was verified at 0.01 ng/mL for PCT-A and at 0.05 ng/mL for PCT-V. The Passing-Bablok regression revealed approximately 20% negative bias of PCT-A compared to PCT-V (PCT-A = 0.042 + 0.79 × PCT-V, r = 0.995). The concordance of the 2 methods at diagnostically important cutoffs (0.10, 0.25, 0.50, and 2.0 ng/mL) was excellent, with overall agreement >93% at each threshold.

CONCLUSION

The results of our study show improved sensitivity and equivalent clinical performance of PCT-A compared to PCT-V. The availability of this test on common clinical immunoassay analyzers may help accelerate its adoption into antimicrobial stewardship programs and thereby improve antibiotic use and patient outcomes.

Authors+Show Affiliations

Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, SC.Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, SC.Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, SC.Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, SC. babic@musc.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31639727

Citation

Wang, Dan, et al. "Comparison of the Abbott Architect BRAHMS and the Biomérieux Vidas BRAHMS Procalcitonin Assays." The Journal of Applied Laboratory Medicine, vol. 3, no. 4, 2019, pp. 580-586.
Wang D, Caddell B, Nolte FS, et al. Comparison of the Abbott Architect BRAHMS and the Biomérieux Vidas BRAHMS Procalcitonin Assays. J Appl Lab Med. 2019;3(4):580-586.
Wang, D., Caddell, B., Nolte, F. S., & Babic, N. (2019). Comparison of the Abbott Architect BRAHMS and the Biomérieux Vidas BRAHMS Procalcitonin Assays. The Journal of Applied Laboratory Medicine, 3(4), pp. 580-586. doi:10.1373/jalm.2018.027268.
Wang D, et al. Comparison of the Abbott Architect BRAHMS and the Biomérieux Vidas BRAHMS Procalcitonin Assays. J Appl Lab Med. 2019;3(4):580-586. PubMed PMID: 31639727.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of the Abbott Architect BRAHMS and the Biomérieux Vidas BRAHMS Procalcitonin Assays. AU - Wang,Dan, AU - Caddell,Brittany, AU - Nolte,Frederick S, AU - Babic,Nikolina, Y1 - 2018/09/19/ PY - 2018/05/31/received PY - 2018/08/07/accepted PY - 2019/10/23/entrez PY - 2019/10/23/pubmed PY - 2019/10/23/medline SP - 580 EP - 586 JF - The journal of applied laboratory medicine JO - J Appl Lab Med VL - 3 IS - 4 N2 - BACKGROUND: Procalcitonin (PCT) is a well-established marker for bacterial infection. Recently the US Food and Drug Administration approved the expanded use of this biomarker to guide clinical decisions for antibiotic treatment in patients with lower respiratory tract infections. Both the Architect BRAHMS PCT (PCT-A) and Vidas BRAHMS PCT (PCT-V) are approved for this indication. The aim of this study is to evaluate analytical performance of PCT-A in comparison to PCT-V. METHODS: PCT-A and PCT-V were evaluated for intra- and interassay precision and functional sensitivity. To assess the accuracy of PCT-A, 108 residual plasma specimens were randomly selected from routine hospital orders, and PCT was measured concurrently with PCT-A and PCT-V. RESULTS: Both assays demonstrated excellent precision, with intraassay precision ranging from 2.2% to 4.0% CV and interassay precision ranging from 2.5% to 3.6% CV. The functional sensitivity was verified at 0.01 ng/mL for PCT-A and at 0.05 ng/mL for PCT-V. The Passing-Bablok regression revealed approximately 20% negative bias of PCT-A compared to PCT-V (PCT-A = 0.042 + 0.79 × PCT-V, r = 0.995). The concordance of the 2 methods at diagnostically important cutoffs (0.10, 0.25, 0.50, and 2.0 ng/mL) was excellent, with overall agreement >93% at each threshold. CONCLUSION: The results of our study show improved sensitivity and equivalent clinical performance of PCT-A compared to PCT-V. The availability of this test on common clinical immunoassay analyzers may help accelerate its adoption into antimicrobial stewardship programs and thereby improve antibiotic use and patient outcomes. SN - 2475-7241 UR - https://www.unboundmedicine.com/medline/citation/31639727/Comparison_of_the_Abbott_Architect_BRAHMS_and_the_Biomérieux_Vidas_BRAHMS_Procalcitonin_Assays L2 - http://jalm.aaccjnls.org/cgi/pmidlookup?view=long&pmid=31639727 DB - PRIME DP - Unbound Medicine ER -