Oral Rapid Antigen Test - Instructions for Use

Validity Laboratory Services

Oral Rapid TM SARS-CoV-2 Rapid Antigen Test (Lateral Flow Immunoassay, LFI) A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. Therefore the ORAL RAPID ™ must undergo clinical validation studies in individual highcomplexity CLIA certified laboratories. It cannot be designed or manufactured completely, or partly, outside of the laboratory that offers and uses them.

The ORAL RAPID ™ test can only be offered for sale as a Laboratory Developed Test under the CLIA guidance for LDT performance. The test will need to be administered by a healthcare professional trained by the respective high complexity laboratory. Although results can be read onsite, they are not official until uploaded to our Test platform and validated by the Lab Director.

This Test must be utilized with LDT Compliance software & sold by high complexity laboratories. Additional information about Antigen Testing Guidelines can be found at https://www.cdc.gov/coronavirus/2019ncov/lab/resources/antigen-tests-guidelines.html Updated December 5th, 2020 FOR PROFESSIONAL USE ONLY PRODUCT NAME Oral Rapid

TM

action to move forward along the test card. If the sample contains novel coronavirus antigen, the antigens will bind with colloidal gold labeling will be coronavirus monoclonal antigen, the immune complex will be membrane fixed will be coronavirus monoclonal antibody capture, form the purple line, display will be coronavirus antigen positive; If the line does not show color, the negative result will be displayed. The test card also contains a quality control line C, which shall appear in magenta regardless of whether there is a detection line.

REAGENTS AND MATERIALS SUPPLIED 1. Main components: 1) Oropharyngeal/Nasophyryngeal swab 2) antigen reagent 3) sample collection dropper tube 4) foil enclosed test card STORAGE AND EXPIRY Store as packaged in the sealed pouch at 2-26℃ (35.6-80F), avoid heat and direct sunlight, store in a dry place. Valid for 12 months. DO NOT FREEZE. Some protective measures to be taken in summer and winter to avoid the test reaching high temperatures or damaged by freezing- thawing. Do not open the inner packaging until ready, as it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when humidity＞60%.

SAMPLE REQUIREMENT WARNING: DO NOT USE VIRAL TRANSPORT MEDIA. WARNING: TEST ADMINISTRATOR MUST USE SWAB SUPPLIED WITHIN THIS KIT OR IT WILL ADVERSELY EFFECT THE RESULTS.

SARS-CoV-2 Rapid Antigen Test

FOR IN VITRO DIAGNOSTIC USE This instruction for use (IFU) must be read carefully prior to use and carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions for use.

WARNING: ONLY USE THE SAMPLE COLLECTION DROPPER SUPPLIED SINCE THE NUMBER OF DROPS AND SIZE OF DROPS HAS BEEN CALIBRATED WITH THE DEVICE. WARNING: DO NOT FREEZE SAMPLES OR REAGENT PRIOR TO TEST ADMINISTRATION. REFRIGERATED COMPONENTS MUST BE PLACED AT ROOM TEMPERATURE FOR 30 MINS PRIOR TO TESTING

PACKING SPECIFICATION 20 Tests/ Kit

WARNING: TEST ADMINISTRATOR MUST AVOID TOUCHING THE TEETH, TONGUE, AND GUMS.

INTENDED USE

WARNING: DO NOT USE SCENTED SANTIZER WIPES OF ANY KIND; INCLUDING CLOROX WIPES.

This product is used for in vitro qualitative detection of the antigen of novel coronavirus in human throat swabs or nasal swabs.

WARNING: DUE TO THE SENSITIVITY OF THE TEST, PERFUME & TOBACCO SMOKE CAN YIELD AN INCONCLUSIVE RESULT.

IN ORDER TO REMAIN COMPLIANT WITH OUR HIGH COMPLEXITY CLIA LABORATORY, THERE ARE STRICT TESTING REPORTING GUIDELINES. REPORTING REQUIRES ELECTRONIC DOCUMENTATION UTLIZING SOFTWARE WHICH IS LINKED TO OUR HIGH COMPLEXITY LABORATORY. ALL HEALTHCARE PROVIDERS MUST BE TRAINED BY OUR LABORATORY. ALL TEST IMAGES MUST BE UPLOADED TO OUR HIPAA COMPLIANT SERVERS AND THEN OFFICIALLY READ BY OUR LABORATORY DIRECTOR PRINCIPLE OF THE PROCEDURE This kit works by immune chromatography. The sample moves with capillary

1. Only DRY Flocked Oropharyngeal (Throat) swabs should be used. a) Do not use any swab not supplied with the kit.

2. Never place a swab after sample collection into VTM PRIOR to obtaining testing results.

3. Only the reagent supplied should be used. a) This reagent should NEVER be frozen 4. Specimen samples may be stored at room temperature for a maximum of 4 hours.

5. Specimen samples may be stored at 2-8℃ (35.6-46F) for up to 7 days. ONLY use the Reagent supplied and NOT in VTM. Specimen samples that have been collected greater than 7 days prior must not be used with Oral Rapid TM SARS-

CoV-2 Rapid Antigen Test Kit. Specimen collection must be repeated.

6. The use of Viral Transport Medium is strictly prohibited with the Oral Rapid TM SARS-CoV-2 Rapid Antigen Test kit.

TEST METHODS Instructions must be read entirely before administering the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used within one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use the contents immediately when the humidity ＞60%.

Preliminary Sample Preparation Procedure: 1.

Allow the kit components and collected specimen samples to equilibrate and reach room temperature. Remove cassette from foil packaging only when ready to test.

2.

Just prior to obtaining the specimen sample, remove the lid of an empty reagent bottle/dropper.

3.

Ensure the lid containing reagent is snapped tight, then shake this tube vigorously. Then carefully pour the contents of the reagent tube into the sample collection dropper tube. Ensure all the reagent is poured by tapping the inverted reagent tube against the sample collection dropper tube. This now becomes the dropper bottle. This will be used to insert the swab into.

4.

Carefully place dropper lid back on the sample collection dropper tube. Be sure not to spill the reagent.

Sample Collection: 1.

Carefully insert the swab into the oropharyngeal cavity of the patient, reaching the posterior surface of the oropharynx.

2.

Swab over the posterior surface of the oropharynx and palatine tonsils. Rotate the swab several times to collect mucosal cells. Avoid touching the teeth, tongue, and gums. a.

Specimens obtained from the teeth, tongue, and gums may lead to decreased test sensitivity and/or a failed result.

3.

Withdraw the swab from the oropharyngeal cavity.

Sample Preparation Procedure: 1.

While holding the Swab, carefully remove the lid of the sample collection dropper bottle and place the swab in the reagent solution. a.

The top 1/3 of the head of the swab should be immersed in the solution.

2.

Stir and roll the swab for at least 30 seconds, ensuring the tip of the swab maintains contact with the sides and bottom of the bottle.

Repeatedly place the swab head into the reagent so as much reagent is absorbed into the swab itself. It is important to make sure that the virus particles have been absorbed into the reagent.

3.

When you are ready to remove the swab, it is critical to remove the swab while squeezing the sides of the tube to extract all the liquid from the swab. a.

4.

5.

After squeezing out the swab against the walls of the dropper tube, please place only swab head back into tube to strain out any residual reagent the remains in the swab.

It is critical to ensure that you have enough sample to perform the test properly.

Place the lid back on the sample collection dropper and begin to gently swirl the bottle 3-5 times.

Measurement Procedure: 1.

Carefully push down the lid and turn upside down the bottle dropper so that you know all the sample solution is used for testing

1

P A

2.

3.

4.

purposes. a. carefully squeeze the bottle dropper so that individual drops pour out into the cassette well SLOWLY. b.

Be sure to only allow 1 drop per squeeze to maintain 30 µL each drop. c.

WARNING: 1 drop every 1 seconds d.

Please use 3 drops. e.

Failure to slowly insert drops into the cassette well, will invalidate the test result and make it difficult to read both control line and result line.

Begin timer.

Allow for control band to appear.

Result should be interpreted within 15 minutes. a.

Results not read within 30 minutes shall be deemed invalid and will require repeat testing.

INTERPRETATION OF RESULTS POSITIVE: Color bands appear on the quality control line (C) and testing line (T).

NEGATIVE: Color bands appear on the quality control line (C) and do not appear on the testing line (T) INVALID: Color band fails to appear on the control line (C), indicating that an operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Note: Any color change around the region of a line, even if faint or indistinct, should be considered a positive result.

LIMITATIONS 1. The test provides preliminary test results. Negative results do not preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other clinical management decisions. Judgement should be made along with RT-PCR results, clinical symptoms, epidemiologic conditions, and other clinical data.

2. In the early stage of infection, the test result may be negative because of low concentration of SARS-CoV-2 antigen level or antigen that has not yet appeared in the sample.

3. This reagent can only qualitatively detect SARS-CoV-2 antigens in oropharyngeal swab. It does not determine the quantitative antigen content in the samples.

4. The accuracy of the test depends on the sample collection process. Improper sample collection, use of VTM, improper sample transportation and storage or freezing and thawing of the sample will affect the test results.

5. Always use matching lot numbers for test cards and R1 reagent. Using other diluents may result in incorrect results.

6. The solution and test card must be equilibrated to room temperature (18℃~26℃) before used. Otherwise, the results may be invalid.

7. Sensitivity may decrease if the sample is not tested immediately. Please test the sample as soon as possible.

8.

Cross reactions may exist due to the N protein in SARS, this has a high homology with the novel coronavirus (SARS-CoV-2). However, the interpretation of the results will not be affected if there are no local, current SARS infections.

9. Root-cause analysis of possible false negative results: Inappropriate sample collection, using non-matching R1 reagent, sample transfer time is too long (more than half an hour), the volume of buffer added when eluted the swab is too much, non-standardized elution

operation, and low viral titer in the sample may all lead to false negative results. In addition, future mutations in viral genes may lead to changes in antigen epitopes, leading to false negative results.

10. Root-cause analysis of possible false positive results: Inappropriate sample collection, using other non-matching solutions, nonstandardized elution operation, these may all lead to false positive results.

Cross-contamination of samples may lead to false positive results. False negative results from matching PCR nucleic acid test are also possible.

11. Root-cause analysis of possible invalid results: If the sample volume is not sufficient in quantity, the chromatography cannot be carried out successfully. The test card could be invalid if the foil package was broken open. The packaging status must be carefully checked before use.

PRECAUTIONS 1. The reagent is a disposable, in vitro diagnostic reagent, which is only used for the detection of human nasal, nasopharyngeal, or oropharyngeal swab. The operation should be carried out strictly according to the instructions. Do not use expired and damaged products.

2. The kit should be sealed and kept away from moisture. Reagents or samples stored at low temperature should be equilibrated to room temperature before they can be used.

3. Reagents should be used as soon as possible after removal from aluminum foil packs, so as to avoid exposure to air and moisture for too long which can affect test results.

4. Do not use swab samples that have been sitting for too long or contaminated.

5. Please operate in accordance with the laboratory testing procedures for infectious diseases. Waste after use should be treated in accordance with infectious substances.

6. Incorrect operation may affect the accuracy of the results, such as insufficient sample mixing, insufficient amount, inaccurate detection time, etc.

7. There should be appropriate biosafety assurance procedures for those substances containing suspected sources of infection. The following are relevant considerations: A) Handle samples and reagents with gloves.

B) Do not smoke, eat, drink, apply cosmetics or handle contact lenses while handling these items.

C) Disinfect the spilled sample or reagent with disinfectant D) Disinfect and treat all samples, reagents, and potential pollutants in accordance with relevant local biohazardous regulations.

E) Each component of the reagent remains stable until the expiry date under proper handling and storage conditions. Do not use expired reagent kit.

2020;165(3):627‐641. doi:10.1007/s00705-019-04518-0 3. Chafekar A, Fielding BC. MERS-CoV: Understanding the Latest Human Coronavirus Threat. Viruses. 2018;10(2):93. Published 2018 Feb 24. doi:10.3390/v10020093

Validity Laboratory Services 8625 S. Federal Highway, Port St Lucie, FL 34952 1-855-752-6879 Oral Rapid TM SARS-CoV-2 Rapid Antigen Test www.OralRapid.com Date of Issue: 11/21/20

Obelis Group Bd Général Wahis, 53 B-1030 Brussels Belgium

SWAB SIZE RATIONAL 20 Flocked Oral Swabs are provided within this kit is (20) for the intended purpose of oral specimen collection.

BIBLIOGRAPHY 1, Peaper DR, Landry ML. Rapid diagnosis of influenza: state of the art. Clin Lab Med. 2014;34(2):365‐385. doi:10.1016/j.cll.2014.02.009 2. Patel J, Sharma P. Design of a novel rapid immunoassay for simultaneous detection of hepatitis C virus core antigen and antibodies. Arch Virol.

2

P A