The effect of simulated field storage conditions on the accuracy of rapid user-friendly blood pathogen detection kits.
Being able to test for the presence of blood pathogens at forward locations could reduce morbidity and mortality in the field. Rapid, user-friendly blood typing kits for detecting Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), and Hepatitis B Virus (HBV) were evaluated to determine their accuracy after storage at various temperatures/humidities. Rates of positive tests of control groups, experimental groups, and industry standards were compared (Fisher's exact chi2, p < or = 0.05). Compared to the control group, 2 of 10 HIV detection devices were adversely affected by exposure to high temperature/high humidity or high temperature/low humidity. With one exception, none of the environmentally exposed HCV or HBV detection devices exhibited significant differences compared to those stored under control conditions. For HIV, HCV, and HBV devices, there were differences compared to the industry standard. Collectively, this evaluation of pathogen detection kits revealed that diagnostic performance varies among products and storage conditions, and that the tested products cannot be considered to be approved for use to screen blood, plasma, cell, or tissue donors.
Naval Medical Research Unit San Antonio/General Dynamics Information Technology, 3650 Chambers Pass, Building 3610, Fort Sam Houston, TX 78234-6315, USA.
Diane R
DR
Bienek
David G
DG
Charlton
D017848:Blood-Borne Pathogens / Q000302:isolation & purification*; D006801:Humans; D008887:Military Medicine; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000379:methods; D014857:Warfare
D011933:Reagent Kits, Diagnostic