COVID19 antigen test | LT Biotech Diagnostics

Product specifications

Intended Use

LT Biotech Ltd. antigen rapid test detects fragments of proteins of the SARS-CoV-2 virus from a human nasal swab sample.

Assay Time

The process doesn’t require a lab, and can be done in home conditions in up to 15 minutes.

Principle

Tests require a swab from the back of nose or throat as a sample and it works by mixing the sample with a solution that unleashes specific viral proteins. That combination is then applied to a paper strip that contains a bespoke antibody optimized to bind these proteins if they are present. Test result is reflected as a band on the paper strip.

Reagents and Materials

Covid-19 (SARS-CoV-2) Antigen (Rapid test) Cassette (swab):

Consumer-friendly, easy to use in home environment
Single-user package
Clear and simple user instructions
No medical background required for user
Single-user package includes complete test kit
Packaging: boxes of 25/50 test kits
Time to reveal results - 10-15 minutes
General accuracy - 99.9% details below:
- Clinical sensitivity: 193/(193+10)x100%=95.07% 95% CI: p± 1.96 x [p(1-p)/n] 1-2 = [91.13%, 99.99%]
- Clinical specificity: 381/(381+1)x100%=99.74% 95% CI: p± 1.96 x [p(1-p)/n]1-2 = [98.55%, 99.99%]
- Total coincidence rate: (193+381) / (193+10+1+381) x 100%=98.12% 95% Cl: p± 1.96 x [p(1-p)/n]1-2 = [97.02%, 99.22%]

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Test Procedure

Step-by-step guide to COVID-19 Test

Step No. 1

Open the box and remove 1 SWAB, 1 EMPTY SPECIMEN TUBE, 1 FULL LIQUID TUBE and 1 BAG WITH THE TEST CASSETTE and put in front of you on the flat table.

Step No. 2

Take BAG WITH THE TEST CASSETTE remove from the packaging bag and placed flat on a dry table.

Step No. 3

Take FULL LIQUID TUBE and EMPTY SPECIMEN TUBE. Remove the top of the FULL LIQUID TUBE and take off the cover of EMPTY SPECIMEN TUBE. Add 10 drops (about 0.3ml) from FULL LIQUID TUBE to the EMPTY SPECIMEN TUBE and close it with the cover. Put in front of you on the table.

Step No. 4

Take and open the bag with a SWAB like is shown in the picture and: Option 1: With the patient's head slightly lifted up, and the mouth wide open, the patient's tonsils are exposed. With a CLEAN SWAB, the patient's tonsils are gently rubbed back and forth at least 3 times, and then the patient's posterior pharyngeal wall are rubbed back and forth at least 3 times; OR Option 2: Let the patient's head relax naturally. Turn the SWAB against the wall of the nostril slowly into the nostril, to the nasal palate, and then rotate while wiping and remove slowly. Attention: Choosing option 1 or 2 is the choice of the client.

Step No. 5

Take the SPECIMEN TUBE and remove the cover. Insert the head of the SWAB into the SPECIMEN TUBE, mix well, squeeze the SWAB 10-15 times by compressing the walls of the SPECIMEN TUBE against the SWAB. Let it stand for 2 minutes. After that take out SWAB from the tube and put it aside. Put on the cover on SPECIMEN TUBE. Attention: SWAB specimen should be tested as soon as possible after collection. Do not use specimens that are obviously contaminate with blood, as it may interfere with the flow of sample with the interpretation of test results.

Step No. 6

Take the test kit CASSETTE and place horizontally on the table.
Take the SPECIMEN TUBE and add 3 drops (about 100ul) of the sample to the TEST CASSETTE hole (S).
Set timer for 15 minutes.

Step No. 7

The positive specimens can be detected at 15 minutes after sample addition.

POSITIVE: Two colored lines appear on the membrane. One line appears in the control region (C) and the other line appears in the test.

‍NEGATIVE: Only one colored line appears in the control region (C). No apparent colored line appears in the test region (T).

‍INVALID: Control line fails to appear. Results from any test which has not produced a control line 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.

Step No. 8

Put the used test substance in the bag and throw it in the appropriate place.

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CERTIFICATE ISO 9000

CERTIFICATE ISO 9001

CERTIFICATE STATE REGISTRATION

CERTIFICATE CE

DECLARATION CE

LT Biotech Certificate (LT)