New Reduced price! COVID-19 IgM/IgG Precised Rapid Test View larger

COVID-19 IgM/IgG Precised Rapid Test

New product

Manufactured by GenBody Inc, South Korea

GenBody COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (lgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood.

Minimum quality for order - one box (20 tests). Every box contains 20 individual packed tests, 1 bottle buffer solution, 25 capillary tubes.

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13 € tax excl.

-2 €

15 € tax excl.

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The outbreak of the novel coronavirus (COVID-19) rapidly transmit all over China and lots of countries. Although molecular test (RT-PCR) has become the standard method for diagnosis of this disease, the method has many limitations. In addition, the high false negative rates were reported. There is an urgent need for an accurate and rapid testing method that quickly identify large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients.

Comparison With Molecular Testing

 

Molecular Testing (RT-PCR)

GenBodyCOVID-19IgM/IgG Rapid Test

Principle

Nucleic acid test of COVID-19

Antibody(IgM&IgG) detection in the bloods

 

Accuracyinthefields

- China:30~50%(Jungangilbo.2020.02.13)

- Depending on the swab positioning of specimen and yield of gene extraction

 

- Before Day 5: very low

- After Day 5: 50~81% for IgM, 81~100% for IgG

Testtime

>6 hours

10 minutes

Testcost

Very expensive

Economic

Users

Skilled & trained

Normal

Specimen

Throat, anal, nasopharyngeal, sputum

Whole blood, serum, plasma

Testcapacity

Limited

Possible to bulk testing

 

Adv/disadvantages

- Good accurate at early stage.

- Difficult to detect at latent or asymptomatic period.

- Appropriate for early stage with limited cases of patients

- Possible to detect at latent or asymptomatic period.

- InaccurateatfromDay0toDay5afterinfection

- Appropriatefor5day-afterwithbulkcasesofpatients

- Possible to detect at latent or asymptomatic period

- Inaccurate at from Day 0 to Day 5 after infection.

- Appropriate for 5 day-after with bulk cases of patients

 

DiagnosticAccuracyofGenBodyCOVID-19IgM/IgG

Parameters

Performance(Ongoing)

Comments

 

Analytical sensitivity

1.84 S/CO for IgM

1.57 S/CO for IgG

 

w. ELISA

 

Sensitivity

Day 3 after symptom:IgM-30%,IgG-0%

After Day 7 from symptom:IgM-80%, IgG->95%

 

w. limitedcases

Specificity

IgM 98% (118/120), IgG: 99% (119/120)

 

 

Interpretation Method

 

Moleculartest

Antibodytest

 

Interpretation

IgM

IgG

Positive

Negative

Negative

Acute infection (D1~D3)

Positive

Positive

Negative

Acute infection (D3~D8)

Positive

Positive

Positive

Infected (D8~D15)

Positive

Negative

Positive

Infected(>D15) or secondary infected

Negative

Positive

Negative

Early stage of infection. Need the additional molecular test

Negative

Positive

Positive

Infection(D8~D15),Need the additional molecular test

 

Negative

 

Negative

 

Positive

Past infection or

(If IgG negative change to IgG positive) infected

Negative

Negative

Negative

Not infected

Testmethod
(GenBodyCOVID-19IgM/IgGRapidDiagnosticKit)