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Home / Assay Kits / Detection Kits

GenomeCov19 IgM/IgG Rapid Test Kit

SKU : BHE10900002

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Applied Biological Materials (abm) Inc.

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Mfr.No.	G630
Featured	• Simple and fast results in under 15 minutes • Highly sensitive via visual inspection • Tests for both IgM and IgG antibodies • No special equipment needed
Field Of Use	Laboratories and healthcare providers must include this information in their patient test report as specified in FDA guidance: This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
Intended Use	The COVID-19 IgM/IgG Rapid Test Kit is a lateral flow immunoassay (Colloidal Gold Method) for the rapid detection of Human IgM and IgG antibodies against COVID-19/ SARS-CoV-2 virus in human whole blood, serum and plasma samples. The test is intended to either aid in the diagnosis of patients with active infections or help screen for asymptomatic carriers and patients who have recovered from infection. The test provides preliminary test results. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Test Principle	The COVID-19 IgM/IgG Rapid Test Kit is a chromatographic immunoassay for the detection of antibodies against SARS-CoV-2. Each test strip has a conjugate pad containing SARS-CoV-2 recombinant antigens conjugated to colloidal gold and a test region on the nitrocellulose membrane coated with anti-human IgM and IgG. If anti-SARS-CoV-2 virus IgM or IgG is present in the specimen, it will react with the SARS-CoV-2 conjugates and the immunocomplex will be captured by the anti-human IgM or IgG in the test line region, resulting in a dark pink band. If the specimen does not contain any SARS-CoV-2 antibodies, no colored line will appear in either of the test line regions, indicating a negative result. As a procedural control, a colored line should appear in the control line region regardless of the color development in any of the other test lines.

Storage	Upon receipt, store the kit components at room temperature (2 - 30°C) for up to 18 months. DO NOT FREEZE. Do not store the test kit in direct sunlight.

Protocols Description	1. If fresh specimens are being tested, proceed to step 2. If the specimen has been frozen, bring the specimen to room temperature slowly and mix well prior to use. 2. Open the sealed pouch containing the COVID-19 Testing Strip and place it on a clean, flat surface. Label the test strip with the specimen ID clearly. 3. Using a transfer pipet (included in the kit), transfer 1 drop of the whole blood, plasma or serum specimen to the test strip sample well. 4. Add 2 - 3 drops of the Sample Buffer to the test strip sample well. 5. The results can be interpreted in 10 minutes. Note: Results must be interpreted within 15 minutes after specimen has been added to the sample well otherwise the test results should be considered invalid and the procedure should be repeated. Negative: Only control line “C” shows a dark pink band. Positive: Both the control line “C” and one of, or both of, “IgM” and “IgG” shows a dark pink band. Inconclusive: The control line “C” shows a dark pink band and “IgM” and/or “IgG” shows a light pink band. It is recommended to repeat the test. Invalid: If no band appears in the control line “C”, the test result is invalid regardless of the presence or absence of band(s) in the “IgM” and “IgG” lines. It is recommended to repeat the test.
Supporting Protocol	COVID-19 IgM IgG Rapid Test Kit Datasheet

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SKU	Supplier No.	Size	Your price	Quantity
BHE10900002	G630	25 Tests/kit	$500		Add to Cart

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