1. INTENDED USE
The 2019-nCOV IgG/IgM Rapid Test is based on rapid immunochromatographic test. It is used for the detection of 2019 Novel Coronavirus (2019-Ncov) IgG and IgM antibody in human serum/plasma, offering a diagnostic reference for COVID-19. The kit is intended for professional use only.
Coronavirus is a type of single-stranded positive-stranded RNA virus with an envelope. It has a diameter of about 60 to 220 nm and is widely present between humans and other mammals. Most coronavirus infections are mild infections, but there are still two coronavirus outbreaks that have caused serious consequences: severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) [ 1, 2]. Specifically, the above two coronaviruses have caused more than 10,000 cases in the past two decades; among them, the lethal rate of SARS-CoV is about 10% and the lethal rate of MERS-CoV is about 37% [3, 4] The 2019-nCOV IgG/IgM Rapid Test is a prescription-use laboratory assay that provides
aid to the diagnosis of COVID-19.
This product uses capture colloidal gold immunochromatography to detect 2019-nCoV protein-specific IgG antibodies and IgM antibodies in human serum/plasma samples. Colloidal gold labeling was used to mark nucleocapsid protein and rabbit IgG antibody. The nucleocapsid protein-colloidal gold complex and rabbit IgG antibody-colloidal gold complex were coated on a colloidal gold pad. The detection line (G), the detection line (M ) and quality control line (C) were coated with mouse anti-human IgG (G line), mouse anti-human IgM (M line) and goat anti-rabbit IgG antibody (C line), respectively. If the test
sample is positive for the IgG antibody, the 2019- nCoV protein-specific IgG antibody combines with the colloidal gold-labeled nucleocapsid protein to form a complex. The complex moves forward along the strip under the chromatographic action and passes the detection line (G line) and will react with pre-coated mouse anti-human IgG antibody, an immune complex is formed to show a red band. Colloidal gold-labeled rabbit IgG antibody shows a red band in combination with goat anti-rabbit IgG antibody at the control line (C line). If the test sample is positive for IgM antibody, the 2019- nCoV protein-specific IgM
antibody combines with colloidal gold-labeled nucleocapsid protein to form a complex,and the complex moves forward along the paper strip under the action of chromatography,passing the detection line (M line) and will react with pre-coated mouse anti-human IgM antibody, an immune complex is formed to show a red band. Colloidal gold-labeled rabbit IgG antibody shows a red band in combination with goat anti-rabbit IgG antibody at the quality control line (C line). If both IgG antibody and IgM antibody are positive in the test sample, the immune complexes will form and red bands will appear when passing through
the test line (G line) and test line (M line). The quality control line (C line) should show red band when testing the sample. The red band shown on the quality control line (C) is the standard for judging whether the chromatographic process is normal, and it also serves as the internal control standard for the reagent. Samples are added into sample pad and test can be achieved within 5-10 minutes.
4. STORAGE and EXPIRATION DATE
1. Test should be stored at 2-30oC in dark and dry place for 18 months. DO NOT freeze the test.
2. Test cassette is recommended to be used within 0.5 hour after opening the bag.
3. Refer to the labels to check the production date and expiry date of the kit.
5. SAMPLE COLLECTION and PREPARATION
1. Collect samples according to standard laboratory procedures. Avoid cross-contamination among samples. Sample labeling should be clear and correct without mistake.
2. Samples volume should no less than 100μL.
3. Sample stability and storage
3.1 Sample transportation Sample transportation should comply with biosafety requirements.
3.2 Sample storage Samples can be stored at 2-8 oC for up to 5 days. For longer storage, store the samples at -20oC for up to 12 months. Maximum 5 repeated freezing and thawing are allowed.
8. TEST PROCEDURE
8.1 Carefully refer to the instruction for use prior to performing the test.
8.2 Take out the kits 30 mins before test, ensure that tests and samples are at room temperature.
8.3 Place test cassettes on flat and clean bench; dispense 10μL of sample supernatants and slowly add into sample pad.
8.4 Add 80μL-100μL Dilution solution into sample pad.
8.5 Read and record the results after 5 minutes (No longer than 20 minutes). Abnormal results may occur after 20 minutes.
9. INTERPRETATION of RESULTS
IgG Positive (+): Presence of two red lines, test line (G) and control line (C), indicates 2019-nCOV IgG antibodies present in samples. IgM Positive (+): Presence of two red lines, test line (M) and control line (C), indicates 2019-nCOV IgM antibodies present in samples. IgG+IgM Positive (+): Presence of three red lines, test line (M), test line (G) and control line (C), indicates 2019-nCOV IgM and IgG antibodies present in samples. Negative (-): Appearance of single control line (C), no red test line (G) and no red test line (M), indicates the absence of 2019-nCOV IgM and IgG antibodies present in samples. Invalid: No red control line (C) appears. Invalid results may due to incorrect operation or loss of efficacy in tests. Repeat test firstly, if problem remains, stop using products in same lot number and contact with local distributor for support.
10. CLINICAL PERFORMANCE
A multiple clinical study enrolled 162 positive serum samples from proven COVID-19 patients, and 300 negative samples. Using this kit, 151 cases out of 162 proven samples were positive, with the sensitivity of 93.20%, 286 cases out of 300 clinical
excluded samples were negative, with specificity of 95.33%.
11. LIMITATIONS of METHODOLOGY
1. The test results of this kit are for clinical reference only. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms / signs, medical history, other laboratory tests, and treatment response.
2. Improper sample collection, transfer, storage, and processing may cause erroneous test results.
1. The product is only for in vitro diagnosis.
2. Inspection of product packing and sealing as well as expiration date is necessary prior to performing the test.
3. Please re-collect samples for test if samples are in severe hemolysis.
4. Tests can be stored at room temperature. Ensure that tests are kept from moisture.Tests stored at low temperature (DO NOT FREEZE) should bring to room temperature before testing.
5. Test should be performed as quickly as possible. Long-time exposure of test to air and moisture will cause invalid results.
6. Overload of samples may result in unexpected results, such as false positives.
7. Accuracy of test can be affected by environment temperature (<10ć or >40ć)and relative humidity (>80%).
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