2019- nCoV IgM IgG Antibody test kit documents
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Rapid Test for COVID-19 IgG/IgM Antibody (Colloidal Gold Method) In order to satisfy the critical, global need for serology assays that can complement nucleic acid (PCR) tests for diagnosing COVID-19 infection, Jinjian launched 2019-nCoV IgM/IgG Antibody Test Kit, which is based on the indirect immunochromatography, it 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.

Suitable for SARS-CoV-2 testing Application When you need a fast, reliable SARS-CoV-2 testing, please turn to Jinjian 2019-nCoV IgM/IgG Antibody Test Kit. Offering lab-quality results at the point of care, in a simple-to-operate and safe way, you can do it by yourself anywhere anytime, no need to be in a professional laboratory. Benefits Fast and reliable results: Safe:Avoiding long time waiting and cross-infection. Works with 20 ul whole blood, 10ul serum or plasma. Tests for both IgM and IgG antibodies. Validated using PCR. 10-15 minutes per test. Positive results may be visible as soon...

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...

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit (Colloidal gold method) Clinical Comparative Trial Report Product name ： Novel Coronavirus (2019-nCoV) IgM/IgG antibody detection kit (Colloidal gold method) Developed by: Hubei Jinjian Biological Co., LTD Test unit: Health Inspection and Testing Institute of Hubei Center for Disease Control and Prevention Trial date: April 9, 2020

1. Overview 1.1 Intended use purpose of the product Novel Coronavirus (2019-nCoV) IgM/IgG antibody in novel Coronavirus (2019-nCoV) samples of human serum, plasma and venous blood samples were qualitatively tested in vitro. This can only be used as a supplementary test indicator for a suspected case with a negative nucleic acid test from a novel Coronavirus or used in conjunction with a nucleic acid test in the diagnosis of a suspected case. It cannot be used as a basis for the diagnosis and exclusion of pneumonia infected with a novel Coronavirus and is not applicable to the screening of...

solved, and the analysis crowd has been defined and made a judgment, the data can be locked. Data processing: After the data is locked, it is handed over to the statistical analyst for analysis. 3.3 Problems occurred in the study and countermeasures The whole test process was smooth without any other problems affecting the test. 4. Experimental design 4.1 Overall design and scheme description of the test The selected samples were randomly numbered. After the end of the test, the blind was unblinded. The correlation and other statistics of the test results of the two groups were conducted to...

Table 2: Summary Statistics Measure Confidence Interval (IgM+ or IgG+; Total) Sensitivity (PPA) (IgM-/IgG-; Total) Specificity (NPA)