Saliva Test Pen

Avoid the discomfort of taking a nasopharyngeal sample.

The COVID-19 Antigen Rapid Test Pen is an in Vitro Immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from saliva samples

 
TEST PEN 2

Benefits:

  • Easy sampling
  • Includes everything required
  • Portable, for use anywhere
  • Easy to operate, no need for specialist training
  • Reducing the risk of contagion to medical professionals

INTENDED USE

The COVID-19 Antigen Rapid Test Pen is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from saliva samples. This test is intended for professional use only.

SUMMARY & EXPLANATION

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease to which people are generally susceptible. Currently, the patients infected by the novel coronavirus are the primary source of infection; however, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days; most commonly seen is 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 COVID-19 Antigen Rapid Test Pen detects SARS-CoV-2 viral antigens through visual interpretation of color development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to coloured particles are immobilized on the conjugated pad. A sample is added to the extraction buffer, which is optimised to release the SARS-CoV-2 antigens from the specimen.

During testing, target antigens, if present in the saliva samples, will be released into the extraction buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to coloured particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess coloured particles are captured in the internal control zone.

The presence of a coloured band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A coloured band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working.

MATERIALS

Materials Provided

Individually packed Saliva Collector with Test Strip

Individually packed Extraction Buffer

Package insert

Materials Required but Not Provided

Clock, timer, or stopwatch

PRECAUTIONS

For in vitro Diagnostic Use Only.

Read the Package Insert prior to use. Directions should be read and followed carefully.

Do not use kits or components beyond the expiration date.

The device contains material of animal origin and should be

handled as a potential biohazard. Do not use if the pouch is damaged or open.

Test devices are packaged in foil pouches that prevent moisture during storage. Inspect each foil pouch before opening. Do not use devices with holes in the foil or where the pouch has not been completely sealed. An erroneous result may occur if test reagents or components are improperly stored.

Do not use the Extraction Buffer if it is discoloured or turbid.

Discolouration or turbidity may be a sign of microbial contamination.

All patient specimens should be handled and discarded as if they

are biologically hazardous. All specimens must be mixed

thoroughly before testing to ensure are presentative sample before testing.

Failure to bring specimens and reagents to room temperature before testing may decrease assay sensitivity. Inaccurate or inappropriate specimen collection, storage, and transport may yield false negative test results.

Avoid skin contact with the buffer.

If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening criteria recommended

by public health authorities, specimens should be collected with appropriate infection control precautions and sent to the state or local health department for testing. Viral isolation in cell culture and initial characterization of viral agents recovered in cultures of SARS-CoV-2specimens are NOT recommended, except in a BSL3laboratory using BSL3 work practices.

STORAGE & STABILITY

Store the COVID-19 Antigen Rapid Test Pen at 2~30˚C when not in use.

DO NOT FREEZE.

Kit contents are stable until the expiration dates marked on their outer packaging and containers.