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

Storage and Stability

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

Performance Characteristics

1. 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%).
2. 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.
3. 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.
4. 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.
5. RF, ANA and AMA don’t exhibit cross reactivity with the test.
6. 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.
7. Systemic lupus erythematosus has no interference effect on the detection of this kit.
8. 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.
9. Heparin, sodium citrate, EDTA and other anticoagulants have no interference effect on the detection of this kit.
10. 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.
11. After the specific IgM positive sample was destroyed by β-mercaptoethanol, the IgM test result was negative.

WHAT YOU WILL NEED

You need the following additional items to run a test:

1. Alcohol wipe
2. Lancet device
3. Pipette