Background MBio Diagnostics is developing a multiplexed immunoassay platform capable of simultaneous detection of serologic disease markers from a single drop of blood. Here we demonstrate the system in the context of HIV and AIDS-related co-infection testing. Multianalyte testing at the time of HIV diagnosis is essential for individualised management of HIV infection. The MBio System is designed to address the unmet need for timely and cost-effective co-infection testing.
Methods The MBio multiplexed immunoassay system is based on single-use disposable cartridges and an inexpensive reader. A simple, 10 minute assay protocol was developed for delivering HIV-1 antibody (Ab) reactivity results on whole blood, plasma, or serum samples. A total of 87 whole blood samples were run with the 10 minute assay. 50 HIV-1 Ab negative samples were used to establish cutoffs. 37 HIV-1 Ab positive samples were used to assess system sensitivity. A set of 5 commercially available HIV-1 seroconversion panels were also used to assess the system. System demonstration in the context of syphilis and hepatitis C virus (HCV) testing was also performed on a subset of clinical specimens.
Results Ab reactivity results using the 10 minute assay protocol showed 100% concordance with known HIV serostatus for the 87 whole blood samples tested. Data for the seroconversion panels showed that MBio System performance meets or exceeds package insert data for FDA-approved HIV Ab rapid diagnostic tests. Simultaneous detection of syphilis (T. pallidum) and HCV Ab reactivity has been demonstrated.
Conclusion s The dataset presented here demonstrates a simple, 10 minute assay protocol on the MBio multiplexed immunoassay system. Multianalyte testing from unprocessed whole blood at the POC should enable improved therapeutic decision making, particularly in limited resource settings.
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