Novel Coronavirus (COVID-19) IgM IgG Antibody Combo Test Kit (Colloidal Gold)
Sample type:
-
plasma
-
serum
-
whole blood
Product Advantage:
- High Detection accuracy
- High cost performance
- Quality assurance
- Fast delivery
Detailed Description
INTENDED USE
For the qualitative detection of the antibodies of IgM/IgG against novel coronavirus in serum, plasma or whole blood from patients with clinical suspicion of COVID-19 infection.
About COVID-19
COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Contents
Package specifications: 25 T/kit
1) Test device: 25 T/kit.
2) Transfer pipet: 25 pcs/kit.
3) Specimen diluent: 200 μL x 25 vials/kit.
4) IFU: 1 piece/kit.
5) Blood lancet: 25 pcs/kit.
6) Alcohol pad: 25 pcs or/kit.
Additional required material: clock/ timer/ stopwatch
Note: Do not mix or interchange different batches of kits.
Specifications
| Test Item | Sample Type | Storage Condition |
| Novel Coronavirus (2019-nCoV) IgM/IgG antibody | Whole Blood/Serum/Plasma or Fingertip blood | 2-30℃ |
| Methodology | Test Time | Shelf Life |
| Colloidal Gold | 15mins | 24 months |
Operation
Interpretation
POSITIVE: Two or three colored lines appear on the membrane. One colored line appears in the control region (C) and the other line appears in the test region (IgM or IgG or both).
NEGATIVE: Only a single colored line appears in the control region (C). No visible colored line appears in the test region (IgM or IgG).
INVALID: The control line (C) does not appear. The tests results which do not show a control line after the specified reading time should be discarded. The sample collection should be checked and repeated with a new test. Stop using the test kit immediately and contact your local dealer if the problem persists.
Clinical Performance
Sensitivity: 96.37% Specificity: 99.05% Accuracy: 97.88%
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