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COVID-19 IgG/IgM Antibody Test

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Description

COVID-19 IgG/IgM Rapid Test

The COVID-19 IgG/IgM Antibody Test is an in vitro, rapid, qualitative immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of COVID-19 in human serum, plasma or whole blood.

This test is only provided for use in laboratories or by healthcare workers at the point-of-care.

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

Positive results may be due to past or present infection with non- SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Not for the screening of donated blood.

FDA Status

Submission for EUA on April 27th, 2020

Product Features

Rapid Antibody Test

Manufacturer

  • Alpha Scientific
    • Poway, California
    • 21 Years in Business – 26 Patents – 50 + products

Distributor

  • Clarity Diagnostics
    • Boca Raton, Florida
    • 160 + medical products in distribution

Product

Clarity COVID-19 IgG/IgM Test Kit (20 test per box)

  • Contents
    • Tests cassettes
    • Developer Solution
    • Pipettes
    • Package Insert
  • Ordered separately from Clarity
    • 21G lancets 100/ box
    • Sterile alcohol prep pads
  • Sample Type
    • Whole Blood (20ul)
    • Sera/Plasma
  • Time to Result
    • <10 Minutes

Clinical Data

  • Result from 300 sample study – Additional studies ongoing 
    • Whole Blood
      • PPA – 100%
      • NPA – 93%
    • Sera/plasma
      • PPA – 97.8%
      • NPA – 94.7%

Coronaviruses are a large family of viruses that are common in many

different species of animals, including camels, cattle, cats, and bats.

The two highly pathogenic viruses, SARS-CoV and MERS-CoV, cause

severe respiratory syndrome in humans, and the other four corona

viruses (HCoV-NL63, HCoV-229E, HCoV-OC43 and HKU1) induce

only mild upper respiratory diseases in immunocompetent hosts,

although some of them can cause severe infections in elderly individuals .

COVID-19 is the virus associated with SARS-CoV-2.

Coronaviruses cause respiratory and intestinal infections in animals and humans. The virus is transmitted mainly via respiratory droplets that people sneeze, cough, or exhale. The incubation period for COVID-19 is currently estimated at between two (2) and fourteen (14) days. Common symptoms of COVID-19 infection include fever, dry cough and respiratory symptoms such as shortness of breath and breathing difficulties. More serious cases develop severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock that can lead to the death of the patient. People with existing chronic conditions seem to be more vulnerable to severe illness. Detection of IgM indicates recent infection and can be used for early diagnosis of infection. IgG antibodies gradually appear and increase in the late stage of infections. This COVID-19 IgG/IgM Rapid Test Device is a Driven Flow® immunoassay for the detection of human anti-SARS-CoV-2 IgG/IgM antibodies.