The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG antibody immobilized in G test area, mouse-anti human IgM antibody immobilized in M test area and the corresponding antibody in quality control area (C).
During the test, when the SARS-CoV-2 IgM antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgM antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgM antibody immobilized in M test area subsequently and this produces a purple-red band appears in the M test area.
When the SARS-CoV-2 IgG antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgG antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgG antibody immobilized in G test area subsequently and this produces a purple-red band appears in the G test area. If it is a negative sample, there is not a purple-red band appeared in the M and G test area. Regardless of the presence or absence of the SARS-CoV-2 antibody in the sample, a purple-red band will appear in the quality control area (C). The purple-red band in the quality control area (C) is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as the internal control standard for reagents.
The product contains 20 tests, one IFU (instruction for use), one bottle of sample dilution and one pack of dropper. For each test, it contains one testing strip and one package of desiccant. The testing strip is composed of one gold standard mat (colloidal gold labeled SARS-CoV-2 recombinant protein), sample mat, cellulose nitrate membrane (Mouse-anti human IgM antibody immobilized in M area, Mouse-anti human IgG antibody immobilized in G area; Goat anti-mouse antibody immobilized in C area), absorbing paper, plastic carrier board.
The test strip can be performed with serum/plasma/whole blood. The blood should be collected by professional medical staff, and it is advised of detecting serum/plasma in priority, and under emergency conditions or special conditions, the whole blood of patients can be used for rapid testing.
After collection of samples, it should be tested immediately. It is forbidden for long time placement of the sample under room temperature. For whole blood sample, if it cannot be tested in time, it can preserve for 24 hours between 2 and 8 ℃. Serum/plasma samples can be preserved for 3 days under temperature between 2 and 8℃, and for long time storage, they should be stored under -20℃, and repeated freeze-thaw cycles should be avoided.
Before testing, the sample must be restored to room temperature, ready for application only after homogeneity. The sample must be returned to room temperature before testing and should be used after mixing. Do not use samples with severe hemolysis, severe lipids, and jaundice.
Please read the instruction for use carefully before performing the test. Before testing, restore the reagents and blood sample to room temperature.
- 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.
- 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.
- Wait for the fuchsia band to appear. The test results should be read within 15 minutes. Do not read the results after 20 minutes.
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 these 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.
Limitation of Procedure
- The test results of this product should be comprehensively judged by the physician in combination with other clinical information and should not be used as the only criterion.
- The product is used to test the SARS-CoV-2 antibody of the tested sample.
- The test device is to be used as an aid in the diagnosis of SARS-Cov-2. Do not use expired products.
- Do not freeze or use after the expiration date (see the packaging for the expiration date).
- Avoid excessive temperature and humidity in the experimental environment. The reaction temperature should be 15-30 ° C and the humidity should be below 70%.
- The package bag contains desiccant, and it should not be taking orally.
- It is recommended to use fresh blood for the sample collection. It is not recommended to use high-fat chyle, jaundice, and high rheumatoid factor samples. Do not use hemolyzed samples.
- When testing, please wear protective clothing, gloves and eye shields.
- Do not use the test card with broken single packaging, unclear marks, and past the expiration date.
- Dispose of used specimens, test cards and other waste in accordance with relevant local laws and regulations.
Lepu Medical (Europe) Cooperatief U.A.
Abe Lenstra Boulevard 36, 8448 JB, Heerenveen,The Netherlands
Tel: +31-515-573399 Fax: +31-515-760020
Distributor for Central Europe:
ArvaLab (Arvali Kft.)
2724, Újlengyel, Petőﬁ Sándor u. 48. Hungary
Budapest Office: 1036 Budapest, Lajos u. 74-76. Fszt. 4 Hungary