Novel Coronavirus IgG IgM Antibody Detection Kit Simple Operation

Rapid Antibody Test Kit CoV-19 IgG/IgM Antibody Detection Rapid Test Kit Simple Operation Rapid Test Kit

Intended Use

The kit is a rapid test intended for the qualitative detection of the IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood sample from patients suspected of COVID-19 infection for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. Results from this test kit should not be used as the sole basis for diagnosis. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection.

The test provides preliminary test results. Negative results don't preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other management decision. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the SARS-CoV-2 IgG/IgM Rapid Test early after infection is unknown.

Specification

Main Components

• 20 Test Cassettes
• 20 Disposable Pipettes
• 1 Sample Buffer
• 1 Instruction Manual

Product Feature

• Sample collection: Easy to sample collection
• Rapid test: To be able to obtain the result rapidly within 15 mins
• Test results: Easy to check test results

Use Step

For Serum/Plasma

1. Remove the test device from the sealed pouch, place it on a clean and level surface with the sample well up.

2. Add serum or plasma (10µl) vertically into the sample well .

3. Add two (2) drops (80-100µl) of sample buffer into the sample well .

4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

For Whole Blood

1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.

2. Add whole blood (20µl) vertically into the sample well .

3. Add two (2) drops (80-100µl) of sample buffer into the sample well .

4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

Interpretation of result

• POSITIVE: Two or three distinct red lines appear. One line should be in the control region (C) and the other line would be in the test region (IgG line, IgM line or both).
• NEGATIVE: One red line appears in the control region(C). No red or pink line appears in the test region (IgG line, IgM line).
• INVALID: No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Advantage

• Easy for use
• Can be used to test whole blood, serums and plasma
• Results in 15 min
• Test in 2 antibodies
• Easy to read results
• No equipment needed
• No sample transport needed

Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagents, electrolyte reagents, wash solution and urine test reagents.
 

Labnovation products are developed in house, tested extensively in clinics and passed strict quality controls. All of our products are CE marked and approved by SFDA. In the past 15 years, our products have been exported to 110 different countries and used in 8000 hospitals worldwide. We provide both ready-to-use final products and bulk OEM reagents, including ready-to-use reagents, concentrated, and powder.

With an investment of 10% of our annual sales into R&D, we release new products every years. We win more and more domestic and international cooperation by company reputation and products quality while we actively take part in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we are well-known by the companies in this field.