Link to instructions for use.
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%
3. See production date and expiration date on label.
- 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.
WHAT YOU WILL NEED
You need the following additional items to run a test:
- Alcohol wipe
- Lancet device