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The anti-SARS-CoV-2 IgG ELISA kit is used for the qualitative detection of of IgG antibodies against the spike protein (S1) of SARS-CoV-2 in human serum or EDTA plasma.

This ELISA can be performed manually or using an automated platform. This test serves as complement to infection diagnosis and provides evidence for a previous infection with SARS-CoV-2.

Rapid immunochromatographic test for the qualitative detection of IgG and IgM antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human whole blood, serum and plasma samples as an aid in diagnosis of Coronavirus (Covid-19) infection.

IgG

Test sensitivity: 91.8 %

Test specificity: 96.4%

Overall Agreement: 95.0%

* Confidence Intervals

IgM

Test sensitivity: 95.7 %

Test specificity: 97.3%

Overall Agreement: 96.8%

* Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of IgG and IgM antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human whole blood, serum and plasma samples as an aid in diagnosis of Coronavirus (Covid-19) infection.

IgG

Test sensitivity: 100% (95% CI*: 86.0% - 100%) 

Test specificity: 98.0% (95% CI*: 89.4% - 99.9%)

Overall Agreement: 98.6% (95% CI*: 92.3% - 99.96%) 

IgM

Test sensitivity: 85.0% (95% CI*: 62.1% - 96.8%) 

Test specificity: 96.0% (95% CI*: 86.3% - 99.5%)

Overall Agreement: 92.9% (95% CI*: 84.1% - 97.6%) 

* Confidence Interval

Rapid immunochromatographic test for the qualitative detection of IgG and IgM antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human whole blood, serum and plasma samples as an aid in diagnosis of Coronavirus (Covid-19) infection.

IgG

Test sensitivity: 91.8 %

Test specificity: 96.4%

Overall Agreement: 95.0%

* Confidence Intervals

IgM

Test sensitivity: 95.7 %

Test specificity: 97.3%

Overall Agreement: 96.8%

* Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of IgG and IgM antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human whole blood, serum and plasma samples as an aid in diagnosis of Coronavirus (Covid-19) infection.

IgG

Test sensitivity: 91.8%

Test specificity: 96.4%

Overall Agreement: 95.0%

* Confidence Intervals

IgM

Test sensitivity: 95.7%

Test specificity: 97.3%

Overall Agreement: 96.8%

* Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigen in human nasopharyngeal swab or nasal swab samples as an aid in rapid diagnosis of Coronavirus (Covid-19) infection.

Nasopharyngeal Swab Specimen

Relative Sensitivity: 96.4% (95% CI*: 89.8% - 99.2%)

Relative Specificity: 99.0% (95% CI*: 96.3% - 99.9%)

Accuracy: 98.2% (95% CI*: 95.8% - 99.4%)

* Confidence Intervals

Nasal Swab Specimen

Relative Sensitivity: 92.9% (95% CI*: 84.1% - 97.6%)

Relative Specificity: >99.9% (95% CI*: 94.0% - 100%)

Accuracy: 96.2% (95% CI*: 91.3% - 98.7%)

* Confidence Intervals

Rapid immunochromatographic test SARS-CoV-2 IgG/IgM - Nucleocapsid (N protein) + Spike Glycoprotein S1 RBD is for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in rapid diagnosis of Coronavirus (Covid-19) infection.

Total sensitivity: 98.3% (95% CI*: 86.2% - 99.9%) 

Total specificity: 99.5% (95% CI*: 96.2% - 99.9%) 

Total accuracy: 98.9%(95% CI*: 96.1% - 99.9%)

* Confidence Intervals

The MutaPLEX® CoV-2 MUT Real-Time RT-PCR Kit is an assay for the simultaneous differentiation of the novel coronavirus (SARS-CoV-2) lineages B.1.1.7 (United Kingdom, UK), B.1.351 (South Africa, ZA) and P.1 (Brasilia, BRA) from biological specimens.

Rapid immunochromatographic test for the qualitative detection of Human Occult Blood in feces. The FOB Rapid Test Cassette (Feces) can detect levels of Fecal Occult Blood as low as 50 ng/mL or 6 μg/g feces.

Relative sensitivity: 189/199=95% (95% CI*: 91%~97.6%)

Relative specificity: 802/806=99.5% (95% CI*: 98.7%~99.9%)

Accuracy: (189+802)/(189+10+4+802) =98.6% (95% CI*: 97.7%~99.2%). 

* Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of influenza A and B antigens in nasopharyngeal swab, throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

Nasopharyngeal Swab Specimen

Relative Sensitivity: Type A 99.0%; Type В 97.7%

Relative Specificity: Type A 98.9%; Type В 99.0%

Accuracy: Type A 98.9%; Type В 98.6%

Throat Swab Specimen

Relative Sensitivity: Type A 95.1%; Type В 94.2%

Relative Specificity: Type A 99.3%; Type В 99.4%

Accuracy: Type A 98.1%; Type В 97.8%

Nasal Aspirate Specimen

Relative Sensitivity: Type A 100%; Type В 97.9%

Relative Specificity: Type A 99.2%; Type В 99.4%

Accuracy: Type A 99.3%; Type В 98.8%

Rapid immunochromatographic test for the qualitative detection of SARS-CoV-2 and Influenza A and B Nucleocapsid Protein antigen from one nasopharyngeal swab samples as an aid in rapid diagnosis of Coronavirus (Covid-19), Influenza A and/or B infection.

SARS-CoV-2 Ag

Test sensitivity: 97.3% (95% CI: 90.0% - 99.8%)

Test specificity: 100.0% (95% CI: 96.6% - 100%)

Relative accuracy: 98.8% (95% CI: 91.8% - 99.9%)
*Confidence Intervals

Influenza type A
Test sensitivity: 92.6%

Test specificity: 96.4%

Overall Agreement: 95.5%

*Confidence Intervals

Influenza type B
Test sensitivity: 90.0%

Test specificity: 95.8%

Overall Agreement: 94.4%

*Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of SARS-CoV-2 and Influenza A and B Nucleocapsid Protein antigen from one nasopharyngeal swab samples as an aid in rapid diagnosis of Coronavirus (Covid-19), Influenza A and/or B infection.

SARS-CoV-2 Ag

Test sensitivity: 97.3% (95% CI: 90.0% - 99.8%)

Test specificity: 100.0% (95% CI: 96.6% - 100%)

Relative accuracy: 98.8% (95% CI: 91.8% - 99.9%)
*Confidence Intervals

Influenza type A
Test sensitivity: 92.6%

Test specificity: 96.4%

Overall Agreement: 95.5%

*Confidence Intervals

Influenza type B
Test sensitivity: 90.0%

Test specificity: 95.8%

Overall Agreement: 94.4%

*Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of SARS-CoV-2 antigens present in human oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

Relative Sensitivity: 90.1%

Relative Specificity: 99.3%

Accuracy: 97.0%

* Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human whole blood, serum or plasma specimens. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent infection or prior.

Rapid immunochromatographic test for the qualitative detection of IgG and IgM antibodies to SARS CoV-2 in fingerstick whole blood.

IgG

Relative Sensitivity: 100% (95% CI*: 86.0% - 100%)

Relative Specificity: 98.0% (95% CI*: 89.4% - 99.9%)

Accuracy: 98.6% (95% CI*: 92.3% - 99.96%) 

* Confidence Interval

IgM 

Relative Sensitivity: 85.0% (95% CI*: 62.1% - 96.8%)

Relative Specificity: 96.0% (95% CI*: 86.3% - 99.5%)  

Accuracy: 92.9% (95% CI*: 84.1% - 97.6%)  

 * Confidence Interval