IFU-2019- nCoV IgM IgG Antibody test kit
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2019-nCoV IgM/IgG Antibody Test Kit (Colloidal Gold Method) For Rapid Detection of SARS-CoV-2 Kit configured for testing human serum, plasma and venous whole blood specimen in vitro For professional in vitro diagnostic use only

For Rapid Detection of SARS-CoV-2 For professional in vitro diagnostic use only PRODUCT NAME 2019-nCoV IgM/IgG Antibody Test Kit (Colloidal Gold Method) INTENDED USE This product is used for qualitative detection of novel coronavirus (SARS-CoV-2) IgM/IgG antibodies in human serum, plasma and venous whole blood specimen in vitro. It is only used as a supplementary for the negative cases of novel coronavirus nucleic acid test, or in conjunction with it in diagnosis of suspected cases. Neither can this test kit be used as a decisive or exclusive evidence for the diagnosis of COVID-19, nor for...

WARNINGS AND PRECAUTIONS 1. The device is designed for testing human serum, plasma or whole blood specimen, other body fluids and specimen may not yield accurate results. 2. Venous blood should be collected under the condition of sterility. It is recommended to use human serum or plasma specimen for testing. 3. Sodium citrate, EDTA, or heparin is recommended for anticoagulation in plasma and whole blood samples. 4. After collection, the specimen should be stored at 2-25℃ and processed within 8 hours; the serum and plasma can be stored at 2-8℃ for 5 days, or under -20℃ for 5 months. The...

Interpretation of novel coronavirus nucleic acid and antibody detection results No infection (most of them fall into this category) or incubation period of infection, contact history should be asked (no exposure for 14 days, which can be excluded) In the acute stage of infection, the nucleic acid results were false negative, it is recommended to review nucleic acid and CT It is suggested that the initial infection load is very low and it is in the early stage, and IgG has not been produced. The low-risk patients are suspected to have the interference of heterophilia antibody or rheumatoid...

PERFORMANCE CHARACTERISTICS Accuracy Negative coincidence rate: the negative coincidence rate of 95 healthy samples was 100%. Positive coincidence rate: 75 clinically samples of confirmed COVID-19 were tested, the positive IgM/IgG compliance rate is as follows: Positive cases 22 53 Infection time 4-10 days 11-24 days IgMcoincidence rate IgG coincidence rate 17(77%) 5(23%) 49(92.5%) 53(100%) Total coincidence rate 17(77%) 53(100%) Cross-Reactivity and Interference 1. Other common causative agents of infectious diseases were evaluated for cross reactivity with the test. Some positive...

Precautions and Cautions 1. This product is a disposable in vitro diagnostic reagent; please does not use after the expiration date. 2. Please read the instructions of this kit carefully before the test 3. The temperature of the experimental environment should not be too high. The reaction temperature should be in the range of 15℃~37℃. The cryogenically stored test card should be opened after returning to room temperature to avoid moisture absorption. 4. There is desiccant in the aluminum foil compound packaging bag, which cannot be taken orally. 5. There should be appropriate biosafety...