Saliva antigen rapid test pen Rapid Response

WORLD’S FIRST ‘NO-SPIT’ SALIVA ANTIGEN RAPID TEST!

Taking the saliva sample straight from inside the mouth is the most convenient and fastest method for detecting the presence of coronavirus. The results will help you decide how to proceed further.

ALL IN ONE – No need to waste time setting up a workstation and handle numerous assay components. All you need is one pen that can be used comfortably in any location.

First and the only no-spit test dedicated to COVID-19 in the world!

Its sponge-like pen tip will collect a sufficient volume of specimen in 2 mins without the need to spit and avoiding uncomfortable nasal/throat swabbing.

The test results can be interpreted quickly in 15 minutes.

Accuracy = 95.3%

Sensitivity = 90%

Specificity = 97%

Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients.

Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

For professional use only.

Important! Negative test results do not completely rule out being infected with SARS-CoV-2. If you continue to suspect any symptoms, further testing is strongly recommended. Call the family doctor hotline 1220.

Test principle:

The Rapid Response® COVID-19 Antigen Rapid Test Pen (Saliva) is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from saliva samples through visual interpretation of colour development. This test is intended for professional use only.

The Rapid Response® COVID-19 Antigen Saliva Test Kit detects SARS-CoV-2 viral antigens through visual interpretation of colour 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 optimized to release the SARS-CoV-2 antigens from 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 at 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.

Test procedure:

Bring devices to room temperature (18~30℃) before use.

1. The Rapid Response® COVID-19 Antigen Saliva Test Kit is for professional use and should only be used for the qualitative detection of SARS-CoV-2 antigen. The intensity of colour in a positive band should not be evaluated as “quantitative or semi-quantitative”.
2. Both viable and nonviable SARS-CoV-2 viruses are detectable with the Rapid Response® COVID-19 Antigen Saliva Test Kit.
3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test but should only be made by the physician after all clinical and laboratory findings have been evaluated.
4. Failure to follow the TEST PROCEDURE and RESULT INTERPRETATION may adversely affect test performance and/or invalidate the test result.
5. Results obtained with this assay, particularly in the case of weak test lines that are difficult to interpret, should be used in conjunction with other clinical information available to the physician.
6. Negative results do not preclude SARS-CoV-2 infection and should be confirmed via molecular assay.

Result interpretation:

1. POSITIVE: Two coloured bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
2. NEGATIVE: Only one coloured band appears, in the control region (C):
   No apparent coloured band appears in the test region (T).
3. INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The colour intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of colour in the test region should be considered positive. Note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

Precautions:

1. For professional use only.
2. Read the Package Insert prior to use. Directions should be read and followed carefully.
3. Do not use kit or components beyond the expiration date.
4. Do not eat, drink, smoke, brush teeth or chew gum for 30 minutes before collecting saliva.
5. The device contains material of animal origin and should be handled as a potential biohazard.
6. Do not use if pouch is damaged or open.
7. Test devices are packaged in foil pouches that exclude moisture during storage. Inspect each foil pouch before opening. Do not use devices that have holes in the foil or where the pouch has not been completely sealed. Erroneous result may occur if test reagents or components are improperly stored.
8. Do not use the Extraction Buffer if it is discoloured or turbid. Discolouration or turbidity may be a sign of microbial contamination.
9. All patient specimens should be handled and discarded as if they are biologically hazardous. All specimens must be mixed thoroughly before testing to ensure a representative sample prior to testing.
10. 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.
11. Avoid skin contact with Extraction Buffer.
12. 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 state or local health departments for testing.
13. Viral isolation in cell culture and initial characterization of viral agents recovered in cultures of SARS-CoV-2 specimens are NOT recommended, except in a BSL3 laboratory using BSL3 work practices.

Store the Rapid Response® COVID-19 Antigen Saliva Test Kit at 2~30℃ when not in use.
DO NOT FREEZE.
Kit contents are stable until the expiration dates marked on their outer packaging and containers.