COVID-19 IGGIGM detection kit (Colloidal gold)
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COMPANY PROFILE COVID-19 IgM/IgG Detection Kit (Colloidal Gold)

COMPANY PROFILE

Zhongshan Chuangyi biochemical engineering was establish in 1999,which located at State health base in zhongshan, guangdong province. Our factory covers an area of 15 acres. We specialize in the research and development of laboratory medical equipments and diagnostic reagents. Our products include hematology analyzer and reagents,biochemical reagents,immunoanalyzer reagents,urine physical component detection reagents, POCT devcies and Rapid detection kit.We have single channel POCT devices,mutil channel POCT devices and Automatic POCT devices ,more than 20 rapaid detection kit.

Hematology reagents FDA approval Identified as the national high and new technology enterprises Registered 49 biochemical reagent items

48 Patents for invention, 21 Utility model, 1 German patent

POCT device and Rapid detection kit

POCT devices(Used for rapid test kit) Single channel POCT device multi channel POCT device full-automatic POCT device

Rapid detection kit (used on POCT device)

COVID-19 IgM/IgG Detection Kit (Colloidal Gold)

One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG AntibodyColloidal Gold Assay ^ead test result directly, not require test equipment.

Prouct packaging and content

COVID-19 IgM/IgG detection kit (Collidal Gold) IgM/IgG COVID-19 IgM/IgG Detection Kit (Colloidal Gold) |LOT| T202004I6-1 2020-04-16 22021-04-15

Cotton swab CHUAIMGYI COVID-19 IgM/IgG detection kit (Collidal Gold)

Blood lancets CHUAIMGYI COVID-19 fgM/IgG detection kit (Collidal Gold)

User Manual

COVID-19 IgM/IgG Detection Kit (Colloidal Gold) Principle ●The test is an antibody-capture immunoassay to detect the COVID-19 IgM/IgG antibody in human serum, plasma or whole blood using colloid gold immunochromatography technology. ●The test card consists of 1) A conjugate pad containing COVID-19 N protein labeled with colloid gold and chicken IgY labeled with colloid gold, 2) A nitrocellulose membrane strip containing two test lines (M and G lines) and a control line (C line). The M line is pre-coated with monoclonal anti-human IgM for the detection of anti-COVID-19 IgM, G line is...

COVID-19 IgM/IgG Detection Kit (Colloidal Gold) Principle ●After the test sample has been applied to the test card, IgM/IgG in the sample binds to the COVID-19 N protein labeled with colloid gold and forms a marked immunocomplex. This complex moves to the test zones (M and G lines) by capillary action. The complex is then captured on the membrane by the pre-coated anti-human IgM/IgG antibody, forming a visible M line and (or) a G line. Unbounded chicken IgY labeled with colloid gold moves to the control zone, conjugates with the pre-coated goat anti-chicken IgY, forming a visible C line.

Result shows in only 10 min at the soonest Sample types: whole blood/ serum/plasma Test both IgM and IgG to improve sensitivity Use in combination with RT-PCR assay for better diagnosis © ► Result comes out in 10 mins Step 3 Test Result» Invalid3 Invalid 4 IgG Positive IgM Positive Negative

COVID-19 Detection situation According to the latest official news from the National Health Commission, the National Health Commission has released the "CoVID-19 Diagnosis and Treatment Protocol (Trial version 7)" Modification of diagnostic criteria Revision of exclusion criteria On the basis of the original nucleic acid test and sequencing, "serological test" was added to the confirmed cases, “COVID-19 IgM IgG positive”or“COVID-19 IgG transfer from negative to positive or the convalescence period of IgG was 4 times higher than the acute period can be confirmed. “COVID-19 IgM IgG...

What is Novel Coronavirus antibody test? IgM Appearing first in the course of infection IgG IgE It's the highest content, the main force of anti - infection immunity

Clinical Significance of IgM/IgG Detection IgM is the first rapid produced antibody, can be detected in the blood, which is indicating recent infection. It is an auxiliary diagnostic indicator. IgG appears later than IgM. Research has showed that there are IgM starts to go down in the body of Novel Coronavirus-intected people within 18 days, meanwhile IgG starts to go up, and exist for a long time, which can be used as an indicator of epidemiological detection Positive IgG indicates infection, but cannot be used to distinguish present and past infections.

Interpretation of IgM and IgG detection result IgM

COVID-19 IgM/IgG Detection Kit (Colloidal Gold) COVID-19 IgM/IgG Detection Kit(CoHoidai Gold) Result Positive agreement of the COVID-19 IgM/IgG Detection Kit (Colloidal Gold) according to days post onset of symptoms. 532 serum specimens are tested by COVID-19 IgM/IgG detection kit including 429 negative specimens and 103 positive specimens according to clinical diagnosis, sensitivity, and specificity, accuracy and kappa are calculated according to formula above, and the results are mentioned as follows, Sensitivity : 90.29% Specificity : 95.57% Accuracy : 94.55% 95% score confidence...

COVID-19 IgM/IgG Detection Kit (Colloidal Gold) COVID-19 IgM/IgG Detection Kit(CoHoidai Gold) Result Positive agreement of the COVID-19 IgM/IgG Detection Kit (Colloidal Gold) according to days post onset of symptoms. 240 plasma specimens are tested by COVID-19 IgM/IgG detection kit including 181 negative specimens and 59 positive specimens according to clinical diagnosis, sensitivity, and specificity, accuracy and kappa are calculated according to formula above, and the results are mentioned as follows, Sensitivity : 93.22% Specificity : 93.92% Accuracy : 93.75% 95% score confidence...

COVID-19 IgM/IgG Detection Kit (Colloidal Gold) COVID-19 IgM/IgG Detection Kit(CoHoidai Gold) Result • Positive agreement of the COVID-19 IgM/IgG Detection Kit (Colloidal Gold) according to days post onset of symptoms . 240 whole blood specimens are tested by COVID-19 IgM/IgG detection kit including 181 negative specimens and 59 positive specimens according to clinical diagnosis, sensitivity, and specificity, accuracy and kappa are calculated according to formula above, and the results are mentioned as follows, Sensitivity : 93.22% Specificity : 94.48% Accuracy : 94.17% 95% score confidence...