INTENDED USEThe 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.
SUMMARYThe 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.
PRINCIPALThe 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.
- Disposable test cassette
- User manual
- Biohazard bag
STORAGE AND STABILITY
- 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
- 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.
- The lot number and the expiration date are printed on each sealed bag.
TEST PROCEDUREAllow the test device and specimens to equilibrate to room temperature (15-30℃ or 59-86℉) prior to testing.
|Zone||Weight||Delivery Fee (RM)|
|West Malaysia||First 1.00 kg||4.80|
|Extra 1.00 kg||2.00|
|East Malaysia||First 0.50 kg||14.30|
|Extra 0.50 kg||5.10|