Testing
Instructions

Please consult the Instructions For Use found in the package
insert of your particular test kit.

Storage and Stability

  • Store at 4℃~ 30℃ (39.2℉~ 86℉)
  • Use the test within 1 hour after opening the pouch under 60% humidity.
  • See production date and expiration date on label.

Performance Characteristics

  • Clinical research was conducted in 5 institutions. Using this kit, 110 cases out of 126 clinically confirmed cases are positive, with the sensitivity of 87.3% (95% CI: 80.40% to 92.0%); 62 cases of clinically excluded cases are totally negative with the specificity of 100% (95% CI: 94.20% to 100%).
  • Avoid using special samples: red background may appear in the hyperlipemia (triglyceride concentration higher than 25 mg/ml), icteric samples (Bilirubin concentration higher than 0.2 mg/mL) and hemolytic specimen (hemoglobin concentration more than 5.0 mg/mL), which may affect the test result.
  • The 2019-nCoV IgM test was also evaluated with samples that are IgM positive for other diseases as listed in the chart in the package insert.  No cross reactivity was observed.
  • The 2019-nCoV IgG test was also evaluated with samples that are IgG positive for other diseases as listed in the chart in the package insert. No cross reactivity was observed.
  • RF, ANA and AMA don’t exhibit cross reactivity with the test.
  • Common antivirals such like Epistine hydrochloride (≤ 4mg/L), Ribavirin (≤ 40mg/L), Interferon (≤ 200mg/L), Oseltamivir (≤ 30mg/L), Abidol (≤40mg/L), Levofloxacin (≤ 200mg/L), Azithromycin (≤100mg/L), Ceftriaxone (≤ 400mg/L), Meropenem (≤ 200mg/L) have no interference effect on the detection of this kit.
  • Systemic lupus erythematosus has no interference effect on the detection of this kit.
  • Non-specific IgM antibody (≤0.8 mg/mL) and non-specific IgG antibody (≤4 mg/mL) have no interference effect on the detection of this kit.
  • Heparin, sodium citrate, EDTA and other anticoagulants have no interference effect on the detection of this kit.
  • The precision experiments were carried out by different experimenters, at different times and at different places, and the results met the manufacturer’s product performance requirements.
  • After the specific IgM positive sample was destroyed by β-mercaptoethanol, the IgM test result was negative.
Package Insert

What You Will Need

You need the following
additional items to run a test:

Alcohol wipe
Lancet device
Pipette

Important Information

  • This test has not been reviewed by the FDA (also called USFDA).  The tests distributed are registered and listed with FDA, and conforms to FDA policy guidance for COVID-19 serological tests.
  • Product Description:  a rapid, qualitative immunoassay that detects antibodies (i.e., IgG and IgM) to SARS-CoV-2, which is the virus that causes COVID-19.
  • Negative results do not preclude 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.
  • For use only by clinical laboratories and healthcare workers at the point-of-care.  All other use is prohibited.
    Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

How it Works

  • The presence of antibody Immunoglobulin G and Immunoglobulin M (IgG and IgM) proteins specific for SARS-CoV-2 IgG and IgM antibodies are indicated by a visible line in the specific region indicated on the device.
  • The following graph is for illustration purposes only. Significant differences in the post-infection incubation period required for seroconversion are believed to exist.