ISO 9001 COVID-19 Antibody Igm Igg Test Kit No Professional

Rapid Test Kit COVID-19 IgG/IgM Antibody Rapid Test Kit 20Tests High Accuracy Rapid Test

Intended Use
Labnovation SARS-CoV-2 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 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. 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.
Specification

TEST PRINCIPLE

• This kit is an immunochromatography assay, using capture method for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM/IgG antibody in human serum, plasma or whole blood sample. When the sample contains the SARS-CoV-2 IgM antibody, it forms a complex with the gold label antigen (SARS-CoV-2 recombinant antigen). The complex moves forward under the action of chromatography and combines with the coated antibody (Mouse anti-human IgM monoclonal antibody) at the IgM line to form a complex and develop color, which is a positive result. When the sample does not contain the SARS-CoV-2 IgM antibody, no complex can be formed and no red band appears in IgM line, which is a negative result.
• When the sample contains the SARS-CoV-2 IgG antibody, it forms a complex with the gold label antigen (SARS-CoV-2 recombinant antigen) .The complex moves forward under the action of chromatography and combines with the coated antibody(Mouse anti-human IgG monoclonal antibody). at the IgG line to form a complex and develop color, which is a positive result. When the sample does not contain the SARS-CoV-2 IgG antibody, no complex can be formed and no red band appears in IgG line, which is a negative result. Regardless of whether the SARS-CoV-2 IgG or IgM antibody is contained in the sample, the gold label quality control antibody will bind with the coated antibody at the C line to form a complex and develop color (C line).

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

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

• 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

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.