Products

Intended Use

This product is suitable for the qualitative detection of COVID-19 / Influenza A / Influenza B in Sputum/Stool samples. It provides an aid in the diagnosis of infection with the above viruses.

SUMMARY

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 14 days, 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.

PRINCIPLE

The test kit contains two test strips:

In one of them, a burgundy colored conjugate pad containing Novel coronavirus recombinant envelope antigens conjugated with Colloid gold (Novel coronavirus conjugates), 2) a nitrocellulose membrane strip containing two test lines (IgG and IgM lines) and a control line (C1 line).

The IgM line is pre-coated with the mouse antihuman IgM antibody, IgG line is coated with Mouse anti-Human IgG antibody. When an adequate volume of test specimen is dispensed into the sample well of the test device, the specimen migrates by capillary action across the device. IgM anti-Novel coronavirus, if present in the specimen, will bind to the Novel coronavirus conjugates.

The immunocomplex is then captured by the reagent pre-coated on the IgM band, forming a burgundy colored IgM line, indicating a Novel coronavirus IgM positive test result. IgG anti-Novel coronavirus if present in the specimen will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent coated on the IgG line, forming a burgundy colored IgG line, indicating a Novel coronavirus IgG positive test result. Absence of any T lines (IgG and IgM) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

In the other strip, the test strip 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 strip 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 (C2) indicating that proper volume of sample has been added and membrane wicking has occurred.

COMPOSITION

Test Card

For Antibody Detection：

Blood Collection Needle
Dropper
Buffer

For Antigen Detection:

Sample Extraction Tube
Cotton Swab
Paper Cup