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COVID-19 IgG/IgM Cassette x 25 (CE Marked SARS-CoV-2 10min Whole Blood/Serum/Plasma Test) for Medical Healthcare Professional Use Only

COVID-19 IgG/IgM Cassette x 25 (CE Marked SARS-CoV-2 10min Whole Blood/Serum/Plasma Test) for Medical Healthcare Professional Use Only (Q25-ABT-IDT-B352) is a rapid test for the qualitative detection of antibodies (IgG and IgM) to SARS-CoV-2 in whole blood, serum, or plasma. For medical healthcare professional in vitro diagnostic use only.
Product Brand: AccuBiotech Co., Ltd.
Product Code: Q25-ABT-IDT-B352

For medical healthcare professional in vitro diagnostic use only


COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary SARS-COV-2 infections.

COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of SARS-COV-2 antigen-coated coloured particles for the detection of IgG and IgM antibodies to SARS-COV-2 in human whole blood, serum, or plasma.

COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) products have been compared to a leading commercial product test using clinical specimens. The results show that relative to leading product tests, Accu-Tell® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) shows 97.4% relative sensitivity and 99.3% relative specificity for IgG and 86.8% relative sensitivity and 98.6% relative specificity for IgM.


PLEASE NOTE THE FOLLOWING LIMITATIONS

1. COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of SARS-COV-2 antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in SARS-COV-2 antibody concentration can be determined by this qualitative test.

2. COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of SARSCOV-2 antibodies in the specimen and should not be used as the sole criteria for the diagnosis of SARS-COV-2.

3. In the early onset of fever, anti-SARS-COV-2 IgM concentrations may be below detectable levels.

4. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.

5. Results from immunosuppressed patients should be interpreted with caution.

6. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

7. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of SARS-COV-2 infection.

Product Specification
Specification TypeSpecification Value
Product RangeRapid and POC Tests
Product CodeQ25-ABT-IDT-B352
Product NameCOVID-19 IgG/IgM Cassette x 25 (CE Marked SARS-CoV-2 10min Whole Blood/Serum/Plasma Test) for Medical Healthcare Professional Use Only
Product CategoryCovid-19 & Coronavirus Assays
Product BrandAccuBiotech Co., Ltd.
Analyte or ApplicationSARS-CoV-2
Size1 x 25 tests
Storage4°C to 30°C