1.A red colored conjugate pad containing mouse anti-novel nucleoprotein monoclonal antibody conjugated with colloidal gold/Latex immunochromatography and a control antibody conjugated with colloidal gold/Latex immunochromatography,
2. A nitrocellulose membrane strip containing one test lines (T lines) and a control line (C line). The T line is pre-coated with antibodies for the detection of novel nucleoprotein, and the C line is pre-coated with a control line antibody.
1.Sepecimen from innasal swabs,pharyngeal swabs,sputum,saliva,bronchoalveolar,lavage,fluid.
2.Remove the saliva collector, and then re-tighten the cap of the sample tube.
3.Shake the sample tube to mix the saliva with the extract thoroughly
4.Squeeze about 60-100ul (About 2 -3drops)specimen diluent onto the test card
5.Read the result at 15 minutes.The result is valid within 15-20 minutes. It must be repeated
6.Read the results.
INTERPRETATION OF ASSAY RESULT
If only the quality control line C appears, and the test lines T are not burgundy, it indicates that no antigen is detected, and the result is negative. Due to the limitation of detection sensitivity, negative results may be caused by antigen concentrations lower than the analytical sensitivity of the product.
If both the quality control line C and the test line T appear , it indicates that antigen is detected.Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnosis is made.
If the quality control line C is not displayed, the test result is invalid regardless of whether there is a burgundy test line, and it should be tested again.
Repeat the test using remaining sample or new sample, if results are not clear.
If the test repeated fail to produce a result, discontinue using the kit and contact the manufacture.
Jinan Babio Biotechnology Co., Ltd.
Founded in 2003, Jinan Babio Biotechnology Co., Ltd. is a professional high-tech enterprise which concentrates on the R&D, manufacturing and selling of in vitro diagnostic reagent. The company was successfully listed on the NEEQ (National Equities Exchange and Quotations) in 2014 (security name: Baibo Biotechnology, stock code: 830774). The company has established a strict quality management system and passed ISO9001:2008 and ISO13485:2003 international quality system certifications. The company has internationally advanced fully automatic production equipment and standard purification workshop of pharmaceutical grade. Baibo has strong biotechnology power, and currently has more than 72 independent intellectual property rights, it undertakes a number of national scientific research projects and has 91 medical device registration certificates approved by CFDA. The company's products mainly involve sampling tube, rapid detection kits, microbial detection reagents, POCT detection reagents, biochemical diagnostic reagents, diagnostic equipment and so on. Babio has been actively involved in the R&D and manufacturing of sampling and testing reagents. Currently, the company's products of transport media, nasal/oral sampling swabs, and the products' quality has been recognized by the medical institutions and laboratories of various countries, In the future, Babio will be committed to providing better technology and services, and continue to struggle for the human health.
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