Biovantion Inc.
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COVID-19 Ag Rapid Saliva Test Device is a rapid chromatographic immunoassay for the qualitative detection of N antigen from SARS-CoV-2 present in human saliva within the first 7 days of symptom onset. This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient.
The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.
Coronavirus is a single-stranded positive-sense RNA virus with an envelope of about 80 to 120 nm in diameter. Its genetic material is the largest of all RNA viruses and is an important pathogen of many domestic animals, pets, and human diseases. It can cause a variety of acute and chronic diseases. Common signs of a person infected with a coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. The 2019 new coronavirus, or “SARS-CoV-2 (COVID-19)” named by the World Health Organization can cause pneumonia epidemic.
The detection results of this kit are for clinical reference only. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.
The COVID-19 Ag Rapid Saliva Test Device uses double antibody sandwich immunoassay. The NC membrane pre-immobilized with monoclonal antibodies against SARS-CoV-2 antigen and anti-mouse polyclonal antibodies, and the colloidal-gold conjugated with monoclonal antibodies specific to SARS-CoV-2 antigen.
If SARS-CoV-2 antigen present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the antigen will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 to 20 minutes in the form of a red line that develops on the strip.
Whether the sample contains the SARS-CoV-2 antigen or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C.
Store the COVID-19 Ag Rapid Saliva Test Device at 2-30°C. Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial.
Product Customization Services:
This product is a cassette type home test kit for Dengue IgG/IgM. It is to be used with urine samples.
The Colloidal Gold Rapid Test is a diagnostic tool designed for qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal swab and throat swab samples. The product is intended for use by healthcare professionals and trained operators.
The product technical support and services include:
• For in vitro diagnostic use only.
• Do not re-use the test device.
• Do not use after the expiration date.
• Do not use the test kit if the pouch is damaged or the seal is broken.
• Perform test at room temperature 15 to 30°C.
•Wear gloves when hanging the samples, avoid touching the reagent membrane and sample window.
• All samples and used accessories should be treated as infectious and discarded according to local regulations.
• Avoid using blood samples.
