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Background: A multiplex test for HBV, HIV, and HCV is advantageous in maximizing resources as these diseases share common risk factors and modes of transmission, but are currently diagnosed through distinct programs during unique patient visits. This study assessed a multiplex point-of-care (POC) test, Multiplo Rapid HBc/HIV/HCV Antibody Test (Multiplo HBc/HIV/HCV), in simultaneously detecting early infection. Multiplo HBc/HIV/HCV is a manually performed, visually interpreted immunoassay which detects antibodies (IgG and IgM) to HIV, HBc, and HCV in serum, plasma, and whole blood (venipuncture and fingerstick).
Methods: 30 HIV, 30 HCV, and 9 HBV seroconversion panels, comprised of 605 members in total, were purchased. Panel members were provided in a blinded fashion to operators for testing using Multiplo HBc/HIV/HCV according to manufacturer instructions. Results were then de-blinded and the average days to detect seroconversion was calculated relative to FDA-approved laboratory-based immunoassays.
Results: Multiplo HBc/HIV/HCV sensitively detected seroconversion in all panels assessed relative to FDA-approved assays. Multiplo HBc/HIV/HCV detected seroconversion 3.7 days later for HBc, 0.4 days later for HIV, and 0.7 days later for HCV. The later HBc detection may be due to fewer panels being assessed; 9 HBV panels vs. 30 for each of HIV and HCV.
Conclusions: Multiplo HBc/HIV/HCV POC enables healthcare providers to maximize available resources, by simultaneously providing rapid results for three diseases with one drop of blood and one test device. Such an approach is beneficial to populations at risk for these infections whose access to care may be limited and who may be easily lost to follow-up, especially as these results show simultaneous detection can be achieved without compromising performance during early infection. Multicenter trials to generate additional performance data are underway in the USA.