2015 American Association For Clinical Chemistry

Carlos Cabrera, Yao Chen, Lei Chang, David H. Wilson
Quanterix Corporation, Lexington, MA

Introduction Nucleic Acid amplification (NAT) has become an indispensable tool in medical research and diagnostics because of its analytical sensitivities in virus detection (in the case of HIV infection, sensitivity is 60 HIV RNA copies/mL or approximately 30 viral particles/mL). The complexity and cost of NAT viral RNA testing can limit its usage in lower resource settings. Although contemporary protein assays and 4th generation HIV combo immunoassays have been validated to be employed in this type of settings, they are still blind to most of acute phase window of HIV infection detectable by NAT. Since each HIV particle is composed of over 2000 copies of p24 capsid protein, having a highly sensitive protein immunoassay to quantify p24 will represent a key opportunity to detect acute HIV infection, which would help further control the spread of the disease. We are presenting an investigational version of this highly sensitive assay as a rapid and simple alternative to NAT for detection of acute HIV infection.