ISO 13485 High Stability Antibody Rapid Test Kit For Any Scene

Rapid Antibody Test Kit SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit 20 Tests For Professional Use Antibody Rapid Test Kit

Intended Use
COVID-19 IgG/IgM Antibody Rapid Test 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. The test Kit 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. But to be attention the test Results from this test kit should not be used as the sole basis for diagnosis. The test provides preliminary test results.
Specification

Main Components

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

Product Feature

• Responsive: High accyracy and stability
• Quick Check: Easy to use in sample step, 15 minutes out of results
• Clear results: The detection board is divided into two lines, the result is clear and easy tp read

Advantage

• Get result within 10-15 minutes.
• High accuracy
• Easy to operate, Suitable for any scene, no professional, no tedious operation
• Facilitates patient treatment decisions quickly
• Little specimens is enough

SAMPLE REQUIREMENT

• The reagent can be used for the serum, plasma and whole blood samples.
• A serum / plasma / whole blood sample must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as anticoagulants in plasma / whole blood samples. Detect immediately after collecting blood.

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.

FAQ

• How about the MOQ?

MOQ is more than 10000 pcs, but our sales team will advise you how much to order based on the products you need, national market conditions, international logistics costs and other factors

• Which certificate you have?

CE, ISO13485

• Do you manufacturer or trading company?

We are factory, all product we supply is R&D and produce by ourself.

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.