Testsealabs SARS-CoV2 (COVID-19) lgG/lgM Antibody Rapid TEST Cassette

Short Description:

Testsealabs®COVID-19 lgG/lgM Antibody Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of lgG and lgM antibodies  to  COVID-19  in human whole blood, serum or plasma specimen.


Product Detail

Product Tags

SARS-CoV-2 lgG/lgM Antibody Test Detection

When body is infected with the new coronavirus, the specific protein of the virus stimulates the immune system and lead to an antibody response, the first antibody to appear is lgM, and then the lgG antibody. From the general process of acute infection, when the lgG antibody appears, the concentration will continue to increase, the lgM will continue to decrease or even disappear, and the lgG antibody will exist for a long time. The simultaneous dynamic monitoring of lgM and lgG antibody can be used in the auxiliary diagnosis of new coronavirus infection.

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Materials Provided

1.Test Devices
2.Buffer
3.Droppers
4.Product Insert

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Operation instructions

Correct use, convenient and quick

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1、Constant Temperature and Static position;
2、Massage finger pulp;
3、Disinfect with alcohol tablet;
4、Blood sampling and acupuncture into the abdomen of fingers;
5、Wipe off the first drop of blood with sterile dry cotton ball;
6、Use disposable micro pipette to suck blood;
7、Added blood drops to the test card;
8、Add diluent and start timing;
9、Alow to stand for 20 minutes to read the resuIt.

Performance Characteristics

Sensitivity and Specificity

The COVID-19 lgG/lgM Test Cassette (Whole Blood/Serum/Plasma) was compared with a commercial PCR).

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The total sensitivity of IgG is 96.6%; 95% CI:(94.9% - 98.3%) The total sensitivity of IgM is 95.1%. (93.9% - 96.3%) Total sensitivity of IgG/IgM obtained from the above table is 97.6%;95% CI: (96.6%-98.6%);

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Total specificity from the above table is 96.3%;95%Cl:(92.8%-98.4%)

Cross-reactivity

The COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) has been tested for anti- influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti- H. Pylori, anti-HIV anti-HCV RF,Anti-Haemophilus,Human coronovinus HKU1,Human coronovinus NL63,Human coronovinus OC43, Human coronovinus 229E and Anti- Rhinoviruspositive specimens. The results showed no cross-reactivity.


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