Pinnacle covID NEO

At a glance:  The Pinnacle covID NEO rapid antibody test contains 25 test cassettes, buffer solution, package insert and quick reference guide for sample collection and results interpretation.  The test may be performed using whole blood, serum or plasma and results are available in 15 minutes.  For Professional Use Only.  For In Vitro Diagnostic Use Only.  All orders ship same or next business day.

covID NEO gives rapid results you can trust.

covID NEO aids in the detection of SARS-CoV2 with one drop of blood (10 µl) in 15 minutes, and can be performed, resulted and interpreted at the point-of-care.  The test is a colloid-gold immunoassay, the same test principle Pinnacle BioLabs has used in its Second Generation FIT® Colon Cancer Detection Test for nine years. In addition to being easily deployed to the world's largest cities or it's farthest corners, it's also clinically validated and has clinical studies published on four continents.

The intelligent design features both IgG antigens to aid in the  detection of persons with Coronavirus for longer periods of time, as well as IgM antigens to aid in the detection of newly infected persons. The image below show results interpretation at the 15 minute mark.  A single line at the "C" region indicates a negative result, and should only be read at the 15 minute mark.  A line visible at the IgM line indicates possible  early infection.  The "triple bar"  positive indicates possible infection consistent with patients who have carried the virus for a longer period of time. 

Cross Reactivity / Analytical Specificity

For the first generation assay, a panel of negative specimens were obtained including 80 serum samples (frozen serum samples stored pre-pandemic), 1 sample (EDTA whole blood) from an individual confirmed to be negative for SARS-CoV-2 via rt-PCR, and 10 fresh fingerstick samples (capillary blood) from individuals confirmed to be negative for SARS-CoV-2 via rt-PCR. All samples were drawn from a population with a high prevalence of vaccination against influenza, HBV, and Haemophilus influenzae. The sample were drawn from a population known to contain a high prevalence of HCV. Testing of the samples was performed in accordance with the manufacturer-supplied package insert. Of these samples, 90/91 showed no T1 or T2 bands, indicating a negative result (98.9% overall specificity). 1/91 showed a T2 band only, indicating a negative result for IgM and positive result for IgG (100% specificity for IgM, 98.9% specificity for IgG).In addition, 5 stored serum samples known to contain anti-RSV IgM and IgG as well as 5 stored serum samples known to contain ANA from individuals were tested. Of these samples, 10/10 showed no T1 or T2 bands, indicating a negative result (100% specificity). In total, 100/101 samples showed no T1 or T2 bands, indicating a negative result (99% specificity).  With covID NEO, additional blocking reagents were added to the assay  to improve LOD (limit of detection) without sacrificing the specificity physicians rely on. 

Download the first generation specificity study

Pandemics require widely deployable tests that are both easy to perform and easy to interpret. covID NEO is both.