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

Intended Use
The COVID-19 IgG/IgM Antibody Rapid Test Kit is 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.
Specification

Main Components

• 20 Test Cassettes
• 20 Disposable Pipettes
• 1 Sample Buffer
• 1 Instruction For Use

Product Feature

• Excellent sensitivity and quality
• Facilitates patient treatment decisions quickly
• One step operate process, easy to use
• Shorter test period with higher performance
• High accuracy

Test Method

Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity＞60%.

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.

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.

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.

• Register your products in our country?

Yes. We can offer full files for you to register.

• Lead time?

Stock 3-7 days in general. Or please contact us by email for specific lead time base on your order quantities.

• Support ODM or OEM?

Yes we support both. If needed,welcome to discuss details with us.

• Production quantity?

It depends on the specification of the products. For big orders, we can produce 100k-250k per day.