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Covid-19 SARS-CoV-2 Antibody IgM IgG Rapid Test Kit

CRS-01

Covid-19 SARS-CoV-2 Antibody IgM IgG Rapid Test Kit(Export Only)

Description
CRS-01 Covid-19 Antibody IgM IgG Rapid Test Result Kit is with CE, IVD and the certificate from Taiwan's Ministry of Health and Welfare. We offer regulatory legal support for your importing. CRS-01 COVID-19 IgM/IgG Rapid Test For SARS-CoV-2 specific IgM/IgG Qualitative Assay. The COVIDual COVID-19 IgM/IgG Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma specimens from patients suspected of SARS CoV-2 infection by a healthcare provider.
Diagnostic tool to prove indication of acute or recent infection in 15-20 minutes.
IgM antibodies SARS-CoV-2 are generally detectable in blood several days after initial infection.
IgG antibodies against SARS-CoV-2 become detectable later following IgM induction.
3 TESTING PROCESS
  • Works with whole blood, serum, and plasma
  • Visually read, on-site, and one-shot lateral flow test
  • Only a small amount (20μL) of blood is taken during the test



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Features

PERFORMANCE CHARACTERISTIC
344 RT-PCR-confirmed cases containing 55 positive and 289 negative specimens are tested. Of the 33 blood specimen from SARS-CoC-2-infected patients (>14 days from symptom onset to blood collection), 31 tested positive for at least one of the antibodies.
Only 2 of the blood specimen from non-SARS-CoC-2-infected patients ested positive.
SENSITIVITY : 93.9% (31/33)
SPECIFICITY : 99.3% (287/289)
ACCURACY : 98.8% (318/322)
  • A positive result may not indicate previous SARS-CoV-2 infection. Consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.
  • This test should not be used for the screening of donated blood.
  • False positive results due to cross-reactivity with antibodies to other coronaviruses, (e.g., HKU1, 229E) can occur.
  • The COVIDual COVID-19 IgM/IgG Rapid Test must be used in accordance with the instructions in this product insert to obtain accurate results.
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