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Please note, these high quality test kits are made in the USA by Biotech. There are plans soon to be manufactured in Australia.
The test offers 94.7% sensitivity and 100% specificity to aid in the early diagnosis of COVID-19.
The OnSite COVID-19 Ag Rapid Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19. The test is designed for use with self-collected samples within the first 7 days post-onset of symptoms, as an aid in identifying SARS-CoV-2 infection.
The OnSite COVID-19 Ag Rapid Test kit includes:
- Instructions for use
- Individually sealed foil pouches containing 1 cassette device and 1 desiccant
- A sealed pouch with pre-filled extraction tubes
- A sample extraction tube rack
- Sterile swabs sealed in a paper-plastic pouch
- Easy-to-use, cost-efficient test that screens for COVID-19 with results in 15 minutes in the comfort of your home.
- Can easily be carried out by people who are 12 and up.
- Uses nasal swab for ease of use and minimisation of discomfort.
- Does not require the use of laboratory equipment or highly trained laboratory technicians.
Expiry: 2 Years from manufacture date
Preparation for procedure
- Ensure the test area is sanitised. Ensure kit contains all materials and kit is not expired.
- Assemble the sample extraction tube rack.
- Remove one pre-filled extraction tube from the sealed pouch and close the pouch with the unused tubes. Hold the pre-filled extraction tube upright and, before opening it, tap the bottom of the tube on a clean, flat surface to ensure that any liquid on the seal is moved down into the tube.
- Carefully remove the foil seal from the extraction tube, and place the open tube in the sample extraction tube rack provided with the kit.
Nasal swab specimens
- Place patients head in a vertical position and looking slightly downward (See figure A)
- Open swab package and do not touch swab’s absorbent tip.
- Insert the entire absorbent tip of the swab in one nostril and rotate at least 5 times. Be sure that the absorbent tip of the swab scrapes against the nasal wall. Stop when you feel resistance (no more than 2-3 cm into the nose).
- Remove swab from nostril and, using the same swab, repeat step 3 in the other nostril.
- Withdraw the swab from the nasal cavity. Insert the absorbent tip of the swab into the extraction buffer tube and swirl the swab at least 5 times. Proceed to specimen extraction following the Assay Procedure described below.
Nasopharyneal swab speciment
- Hold the patient’s head in a vertical position and looking slightly upwards (see Figure B).
- Open the swab package. Note: Do not touch the swab’s absorbent tip, so be sure to open the package on the opposite end.
- Carefully insert the entire absorbent swab tip into the patient’s nostril that presents the most secretion, keeping it near the nose septum floor while gently pushing into the posterior nasopharynx.
- Rotate the swab at least 5 times.
- Withdraw the swab from the nasal cavity. Insert the absorbent tip of the swab into the extraction buffer tube and swirl the swab at least 5 times. Proceed to specimen extraction following the Assay Procedure described below
- Squeeze the tube against the submerged swab several times to facilitate extraction of the specimen. Remove the swab, place it back in its original wrapping and dispose into a biohazard disposal container.
- Place the nozzle onto the extraction tube and ensure it is attached firmly.
- Remove the cassette device from the sealed pouch just prior to testing. Lay the device on a clean, flat surface and label with specimen ID/name.
- Invert the sample extraction tube and slowly add 3 drops of the extracted specimen into the sample well of the cassette device by gently squeezing the sample tube.
- Set the timing device for 15 minutes. 6. Read the results after 15 minutes.
Note: The result might be visible after a shorter time, however, it should only be interpreted between 15-20 minutes after dispensing the sample material onto the cassette device. Collect all used items (swab, cassette, sample extraction tube, foil seal and nozzle, and used gloves) and discard as biohazardous waste following local laws governing the disposal of devices.
Interpretation of results
NEGATIVE RESULT: If only the C line develops, the test did not detect SARSCoV-2 virus (antigen) is present in the specimen. The result is negative or nonreactive.
POSITIVE RESULT: If both the C line and Ag line develop, SARS-CoV or SARS-CoV-2 virus (antigen) is detected in the specimen. The result is positive or reactive. Some specimens might produce a faint band, but every visible test line band indicates a positive result independent of the band intensity.
INVALID: If no C line develops, the assay is invalid regardless of color development on the Ag line. Repeat the assay with a new device.