CE FDA One Step Covid-19 Testing Kit Igg Igm 99% Accuracy

CE FDA One Step Covid-19 Testing Kit Igg Igm 99% Accuracy

Qualified coronavirus (COVID-19) Rapid Test Kit is affordable, high sensitivity, high specificity, user friendly, equipment free,with CE/ISO13485 and FDA, used in labs, hospitals, examination center for fighting again Coronavirus.
Chat Now

Product Details

Covid-19 Test Kits

Product Name

SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)


One test per bag for one person, 20 tests/kit

Intended Use

The product is intended for the qualitative detection of antibody  content against SARS-CoV-2 in clinical samples  (serum/plasma/whole blood).

【Test Method】

1. Remove the test strip from the packaging reagent bag and use it within 1 hour, especially in an environment with room temperature higher than 30 ° C or in high humidity.

2. Place the kit on a clean platform.

⚫ Serum or plasma sample: Add 10 uL of serum or plasma sample to well A, and then add two drops (about 80 uL) of sample dilution to well B, and start timing.

⚫ Whole blood sample: Add 20 uL of whole blood sample to sample well A, and then add two drops (about 80 uL) of sample dilution to sample well B, and start timing. 3. Wait for the fuchsia band to appear. The test results should be read within 10-20 minutes. Do not read the results after 20 minutes.

【The Explanation of the Testing Results】

⚫ Positive (+): There appear purple stripes in both quality control area and either area M or G.

⚫ Negative (-): There is only one purple stripe in the quality control area (C), and without purple stripe in either test area M and test area G.

⚫ Invalid: There is no purple stripe in the quality control area (C), indicating incorrect operating procedures or the testing strip has already deteriorated. Under this conditions, it must read the instruction for use again carefully, and then use the new test strips to test again. If the problem still exists, stop using this lot number immediately and contact the local suppliers.

anti body test kit Covid-19

Feel Free to Contact Us for More Documents

1. Product Picture

2. ISO13485 vertification of manufacturing body.
3. China SFDA Beijing Test Report.
4. CE DOC of Lepu European.
5. TUV Report to CE DOC.
6. USFDA EUA - Application Letter.
7. USFDA EUA - Establishment Registration n Listing
8. Clinical study of product. (shows accuracy 97%+)
9. User Manual IFU.
10. Usage Instruction of COVID19 Test Kit Lepu Medical.
11. Package Info 44x33x47cm GW 10KG.
12. Feedback Letter from a Italian Hospital.
13. Exporting to Spain - Customs Clearance Doc

Hot Tags: ce fda one step covid-19 testing kit igg igm 99% accuracy, China, manufacturers, factory, buy


You Might Also Like