In:
Transfusion, Wiley, Vol. 59, No. 4 ( 2019-04), p. 1283-1290
Abstract:
Chikungunya (CHIKV) and dengue (DENV) viruses are primarily mosquito‐borne, but transfusion transmission can occur (DENV) or is likely (CHIKV). In the absence of commercially available blood screening assays, a variety of strategies to ensure recipient safety in the face of expanding CHIKV and/or DENV outbreaks have been used. STUDY DESIGN AND METHODS Performance of cobas CHIKV/DENV, a qualitative RNA detection assay for use on the cobas 6800/8800 Systems, was evaluated at two sites (Roche Molecular Systems, Inc. [RMS], and the American Red Cross [ARC] ). Analytical sensitivity, genotype inclusion, correlation with other assays, and reproducibility used clinical CHIKV‐ or DENV‐positive samples and secondary standards for DENV Types 1 to 4 and for three CHIKV genotypes (Asian; East Central South African; and West African); each secondary standard was traceable to international reference panels or reagents. Evaluation of analytic specificity assessed other microorganisms for interference and cross‐reactivity; clinical specificity was determined by individually testing 10,528 volunteer blood donations from the continental United States. RESULTS The 50 and 95% limit of detection (LoD) obtained by RMS for CHIKV, Asian genotype was 1.8 and 6.8 Detectable Units (DU)/mL, respectively, and 0.14 and 0.63 International Units (IU)/mL, respectively for DENV‐1. No significant differences in detection occurred by testing at a second site, the ARC (2.4 and 10.5 DU/mL for CHIKV and 0.15 and 0.60 IU/mL for DENV). Clinical specificity was 100% (95% confidence interval, 99.965%‐100%) for CHIKV and DENV. CONCLUSIONS The high sensitivity and specificity of the cobas CHIKV/DENV test, as demonstrated in these evaluations, indicate its suitability for blood donation screening.
Type of Medium:
Online Resource
ISSN:
0041-1132
,
1537-2995
DOI:
10.1111/trf.2019.59.issue-4
Language:
English
Publisher:
Wiley
Publication Date:
2019
detail.hit.zdb_id:
2018415-3
