INTENDED USE

The iHealth Novel Corona Virus (SARS-CoV-2) Salivary Antigen Rapid Test Kit (Dipstick) Self-Test Device is suitable for the qualitative detection of novel coronavirus, or COVID-19, in Saliva. It aids in the diagnosis of
infection with novel coronavirus.

SUMMARY

The novel coronaviruses (SARS-CoV-2) belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible to infection. 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, particularly 3 to 7 days. The main symptoms include fever, fatigue, and dry cough, nasal congestion, runny nose, sore throat, myalgia, and diarrhea are also found in some cases.

PRINCIPAL

The iHealth Novel Corona Virus (SARS-CoV-2) Salivary Antigen Rapid Test Kit (Dipstick) Self Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in Saliva samples. 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 (C) indicating that proper volume of sample has been added and membrane wicking has occurred.

COMPOSITION

1. Disposable test cassette
2. User manual
3. Biohazard bag

STORAGE AND STABILITY

1. Store as packaged in the hermetically-sealed bag at the temperature (2-30℃ or 38-86℉) and avoid direct sunlight. The kit is stable within the expiration date printed on the labelling
2. Once the sealed bag is opened, the test should be used within one hour. Prolonged exposure to hot and humid environments will cause product deterioration.
3. The lot number and the expiration date are printed on each sealed bag.

TEST PROCEDURE

Allow the test device and specimens to equilibrate to room temperature (15-30℃ or 59-86℉) prior to testing.