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At a glance: The Pinnacle BioLabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test® Clinical Pack 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. This test is for professional use only. Call 1-800-609-6419 for order routing.
Every Second CountsCovid-19 is a silent infection in some, and life-threatening to others. The Pinnacle BioLabs COVID-19 novel Coronavirus Dual IgG/IgM Rapid test looks for Immunoglobin G and Immunoglobin M to aid in the detection of novel Coronavirus.
Early DetectionAs with any disease state, early detection is key. IgM is designed to aid in the detection of early infection of Coronavirus. Patient history and symptoms play a critical role in point of care testing, and should always be performed under the guidance of a physician.
Test Anywhere, AnytimeWith just 10 µL of blood from a finger stick, the Pinnacle BioLabs COVID-19 novel Coronavirus Dual IgG/IgM Rapid test is mobile, and can be deployed in nursing homes, drive-up testing facilities, ER rooms, or anywhere else it is needed. In addition to the 5 mL buffer solution, smaller 1 mL bottles are available.
The Pinnacle BioLabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test® aids in the detection of Coronavirus 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.
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. A recent study by the State of Delaware shows specificity of ~99.5%, with no cross-reactivity with ANA or RSV. 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.
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).Download the specificity study.
The above visual shows the Pinnacle BioLabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test design. Immunoglobulin G (IgG), the most abundant type of antibody, is found in all body fluids and protects against bacterial and viral infections. Immunoglobulin M (IgM), which is found mainly in the blood and lymph fluid, is the first antibody to be made by the body to fight a new infection.