2019-nCoV IgG/IgM Antibody Rapid Test Kit (Colloidal gold Assay)
1)High specificity, high sensitivity, time The protein purified from inactivated 2019-nCoV IgG/IgM virus lysates used as coating antigen test result in 15 minutes.
2)High safety Compatible with blood samples, without the risk of conjunctival exposure yo virus for medical staff comparing to nasopharyngeal swab or BALF.
3)Accurate result Double confirmation by the test results of both IgG and IgM antibodies available at 94% of accurate result.
4)Lower cost Less time consuming, affordable price for consumables, reagents and no equipment required.
5)Convenient No space separation required by majority of PCR kit, suitable for high throughput test.
INTENDED USE It is used for the qualitative detection of novel coronavirus IgG and IgM antibodies in human serum, plasma or whole blood in vitro. Coronavirus is a large family that exists widely in nature. It is susceptible to humans and many animals. It is named for its corona-like fibroids on the surface of its virus particles. The typical clinical symptoms of the new coronavirus (2019- nCoV) infection are fever, fatigue, muscle soreness, and dry cough, which can progress to severe pneumonia, respiratory failure, and even life-threatening. Current evidence indicates that the new coronavirus is transmitted mainly through droplets, aerosols, and direct contact with secretions. After humans are infected with the new coronavirus (2019-nCoV), the human immune system will generate an immune response against the virus, producing specific antibodies. Detection of relevant antibodies can be used to screen for infection with the new coronavirus. Therefore, it is of great clinical significance to establish a simple, safe and reliable new method for laboratory diagnosis of coronavirus.
PRINCIPLE This kit is based on the principle of colloidal gold technology. After an appropriate amount of sample is added to the detection well, the sample moves under the action of the capillary. The new coronavirus IgG / IgM antibody in the sample will combine with the colloidal gold-labeled new coronavirus antigen to form a colloidal gold-antigen-antibody complex. The immune complex product is then chromatographed along the nitrocellulose membrane to the detection area (M), combined with the pre-coated monoclonal anti-human IgM to form a purple M line, showing that the new coronavirus IgM is positive. The immune complex continuously is chromatographed to the detection area (G ) and combined with pre-coated anti-human IgG to form a purple G-line, showing a new coronavirus IgG positive. The quality control antibody-labeled colloidal gold particles are chromatographed to the quality control area (C) and combined with the pre-coated anti-quality control antibody to form a purple C line, indicating that the test is effective. If the QC line does not appear, the test result is invalid.
STORAGE AND STABILITY The cassette is stable for 18months (while sealed in an aluminum foil pouch) if stored at 2 - 30°C. The kit is effective in 1 hour after moving from aluminum foil pouch. The date of manufacture is detailed in the label. Note: Components of different batches can’t be mixed.
SAMPLE REQUIREMENTS • Clinical fresh non-hemolyzed serum, plasma or whole blood (EDTA anticoagulation) samples. • After sampling, the sample should be tested within 24h at room temperature. The sample should be stored for no more than 5 days in cold condition of 2-8°C and should be stored for no more than one month in cryopreservation condition of -18°C. The whole blood sample should be stored for no more than five days at 2-8°C if it can’t be tested within two hours after sampling. • The sample needs to be restored to room temperature before testing. Cryopreserved samples need to be completely melted, rewarmed, mixed evenly before use, avoid freezing and thawing repeatedly.
TEST PROCEDURE 1. Please read the manual of the kit before operation. 2. If the sample is stored refrigerated or frozen, please allow the sample to fully melt at room temperature (20-30 °C), and mix the sample upside down before use. 3. Before starting the test, remove the test strip from the aluminum foil bag, lay it flat on the table, and mark the sample number. 4. Use a sample gun or a dropper to draw 10ul of the sample to be tested (serum, plasma or whole blood sample) into the sample well on the test card. Immediately add 2 drops (70-90ul) of the sample dilution solution to the sample well, and avoid significant bubbles during operation. 5. Count and read the results within 15 minutes at room temperature. Please strictly control the reaction time and read the result within 15 minutes.
PRODUCT PERFORMANCE Appearance: The appearance of the reagent should be neat and tidy, and the text symbol should be clearly marked. There is no leakage. The test strip is intact. The positive rate, precision, and minimum detection limit of this product meet the requirements of quality standards, and the product quality is stable during the validity period. Hepatitis B virus surface antigen antibody, Hepatitis C virus antibody, Hepatitis E virus IgM antibody, Hepatitis A virus IgM antibody, Syphilis antibody, HIV antibody, Rheumatoid factor, Antinuclear antibody, Coxsackie virus A16 IgM antibodies, adenovirus IgM antibodies, respiratory syncytial virus IgM antibodies, influenza A virus antibodies, EV71 virus IgM antibodies, Mycoplasma pneumoniae IgM antibodies, anti-mitochondrial antibody (AMA) positive samples, and high-concentration non-specific IgG (serum total IgG) will not cause interference with this product.
Notes • This product is for in vitro diagnostic use only. • The operation steps cannot be omitted or simplified. • The positive samples detected by this kit need to be confirmed by other methods. • Disinfect or treat all samples and reagents as potential sources of contamination in accordance with local regulations. LIMITATIONS OF THE TEST 1. This reagent is a qualitative test and cannot be used for quantitative determination of antibody content. 2. This reagent is used for the detection of human whole blood, serum or plasma samples. It cannot be used for the detection of saliva, urine or other body fluids. 3. The test results of this product are for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms / signs, medical history, other laboratory tests, treatment response, and epidemiology. 4. In the early stage of infection, if the virus-specific IgM antibody is not produced or the titer is very low, it will lead to negative results. If a virus
The test results are divided into three cases: negative, positive or invalid. The specific interpretation methods are as follows: infection is suspected, the patient should be reminded to check again within 10-20 days and take a second sample, which should be the same as the first sample. Simultaneously test under conditions to determine if there is a seroconversion or a virus-specific IgG or IgM antibody titer that is significantly higher in the first infection. 5. The interpretation of positive results should be further determined in conjunction with clinical symptoms and other etiological methods (nucleic acid and sequencing). 6. Negative results indicate that no new coronavirus IgM / IgG antibodies have been detected, but if the new coronavirus IgM / IgG antibody content in the sample is below the minimum detection limit of the kit, negative results may also be obtained.
DISCLAIMER: The Manufacture of these kits have notified the FDA that we will begin offering the SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit. The test is being made available under compliance with Section IV.D. of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Updated FDA guidance, issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The FDA has not reviewed the validation of this test.
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