for professional use Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold)

【INTENDED USE】

This kit is used to qualitatively detect the novel coronavirus (SARS-CoV-2) nucleocapsid protein antigen in human nasopharyngeal swab samples in vitro. In the acute phase of infection, antigens are usually detectable in upper respiratory tract specimens. The rapid diagnosis of SARS-Cov-2 infection will help medical professionals treat patients and control the disease more effectively. Testing is limited to supplementary detection indicator for suspected nucleic acid negative results or in conjunction with nucleic acid detection in the diagnosis of suspected cases. It should not be used as the basis for diagnosis and exclusion of Novel Coronavirus Pneumonia. It is not suitable for general screening.
For medical institutions use only.

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Further confirmation is needed for positive results. Negative results do not rule out of the possibility of infection. This product is only used for clinical and emergency stockpile in the period of pneumonia outbreak caused by Novel Coronavirus since December 2019, not used as conventional in vitro diagnostic reagent for clinical use. The test results of this kit are for clinical reference only. It is suggested to be comprehensively analyzed based on the clinical manifestation of patient and other laboratory results.

Laboratory testing of Novel Coronavirus (SARS-CoV-2) should be in accordance with the Technical Guidelines for COVID-19 Laboratory Testing to do a better bio-safety job.

【PRINCIPLE OF THE PROCEDURE】

The novel coronavirus (SARS-CoV-2) antigen detection kit (colloidal gold) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in nasopharyngeal (NP) swab. The test card is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad.

The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole Reaction bar is fixed inside a plastic device. When the sample is added into the sample well, conjugates dried in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen presents in the sample, a complex formed between the anti-SARS-2 conjugate and the virus will be captured by the specific anti-SARS-2 monoclonal antibodies coated on the test line region (T). Absence of the T line suggests a negative result.

To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.