FCC ID: 2A8FMU202025-1 GenuIN COVID-19 Rapid PCR Test

GenuIN COVID-19 Rapid PCR Test Instruction for Use IVD

[PRODUCT NAME]

GenuIN COVID-19 Rapid PCR Test

[PACKING SPECIFICATION]

1 REF U202025-1

[INTENDED USE]

The GenuIN COVID-19 Rapid PCR Test is a single-use test kit intended to detect SARS-CoV-2 that causes COVID-19. This test is for home use with self-collected anterior nasal swab specimens in individuals aged 14 years and older (self-collected) or individuals aged 2~13 years (collected by an adult) with suspected COVID-19. The assay is only used for auxiliary diagnosis of SARS-CoV-2 infection. This assay applies isothermal amplication and the nucleic acid lateral ow assay to detect and identify specic sequences of SARS-CoV-2 RNA. This assay is similar to a PCR test in that it utilizes a molecular amplication technology for the detection of SARS-CoV-2 viral RNA. SARS-CoV-2 viral RNA is generally detectable in anterior nasal swab specimens during the acute phase of infection. In general, in vitro testing for SARS-CoV-2 infection is most accurate in the rst week after symptom onset. Individuals diagnosed with COVID-19 within 3 months are recommended to rst seek medical advice of testing because SARS-CoV-2 RNA is detectable in upper respiratory tract specimens even for weeks after the onset of symptoms. Persons who test positive with the GenuIN COVID-19 Rapid PCR Test should seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary. Positive results do not rule out bacterial infection or co-infec-

tion with other viruses. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider. COVID-19 is an acute respiratory infectious disease. All individuals infected COVID-19 are a source of infection. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 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. It is dicult to dierentiate between COVID-19 and respiratory infections caused by other pathogens through clinical manifestations because the symptoms of respiratory infections caused by these pathogens are similar. Results of the assay are for clinical reference only, and shall not be used as the sole basis for diagnosing or excluding cases.

[TEST PRINCIPLE]

The assay applies cross priming amplication (CPA) and nucleic acid lateral ow to qualitatively detect the specic sequence of SARS-CoV-2 RNA (genes ORF1ab and N). With the self-driven heating module, the assay can perform isothermal amplication reactions through specic amplication primers, probes, RNA reverse transcriptase, and DNA polymerase with high strand displacement activity. The viral RNA was rst transferred to DNA with RNA reverse transcriptase and then amplied with DNA polymerase. The assay consists of a module preloaded with nucleic acid amplication reagent and corresponding lateral ow strip. The paper strip is used for rapid detection of nucleic acid amplication products by

>>>1 chromatographic double antibody sandwich method. Biotin and FAM probe are modied at both ends of one specic primer in the reaction system. For positive samples, due to capillary forces, reported nucleic acid fragment ow from sample pad side to detection pad, then the FAM end of nucleic acid will combine with colloidal gold particles and binds specically to the T-line with secondary antibody. In the process of chromatography, the other end is captured by streptavidin (line C), so line C with T line color at the same time. For negative samples, only one end of modied biotin is captured by streptavidin (line C) during chromatography, so only C line is colored. If there is an operation error, only T, or both T and C are not colored, the result is regarded as invalid. 15x

[MATERIALS PROVIDED]

4. Load Sample and Run Test No. Materials Provided Quantity 1 2 3 4 5 6 Disposable sampling swab Sample tube

(Prelled with lysis buer) Dripper Buer A (Prelled in bubbles) Test cassette Zip-lock bag Note:

1. Do not mix materials from dierent lots. 2. Do not reuse the materials of the assay. 1 1 1 2 1 1

[STORAGE CONDITIONS & VALIDITY PERIOD]

1.Usage: the kit should be used at 2~30. 2.Storage: the kit should be stored at 2~8. 3.Validity period: 6 months. Refer to the package for the production date and expiry date. 4.Transportation: The kit performance will not be aected by temperature 2~30 transpor-

tation within 15 days.

[SAMPLE COLLECTION AND HANDLING]

1. Sample types: anterior nasal swabs 2. Sample storage The samples should be sent for testing as soon as possible after collection.

[TEST PROCEDURE]

Note: Read this IFU carefully before using. 1. Prepare for test Insert swab into the sample tube and make sure the swab tip is fully immersed in the lysis buer.

-Stir the swab and press the tube bottom for 15 times to release the sample fully.

-Dispose of the swab into the ziplock bag.

-Put on the dripper.

-Take out the test cassette and place it on a clean at surface with the side of sample hole facing up.

-Open the cap of sample hole.

-Press the sample tube lightly to add only one drop lysis buer into the sample hole.

-Open one bubble of buer A and add all of it into the sample hole.

-Cover the cap of test cassette.

-Connect the cassette with power supply by the USB Type-C cable and connector (output voltage: 5V).

-If the blue light is on, the cassette is working;

otherwise, please change the power supply.

-Do not move the cassette when the test is running.

-Wait 35 minutes.

-Pull out the Type-C connector and open the cap of sample hole.

-Open another bubble of Buer A and add all of it into the hole, then close with the cap again.

-The result can be read in 5 min.

SPECIMEN BAG Zip-lock bag Disposable sampling swab Sample tube Dripper Buer A Test cassette

-Take out all components from the package. 5. Reading the result Read the test result according to the notice provided on the test cassette. Note: Please make sure to check the test result within 30 minutes after adding the second bubble of Buer A.

[INTERPRETATION OF RESULTS]

The result of COVID-19 test is shown in the Test area of result window. The kit contains internal control material to conrm the lateral ow worked. The result of internal control is shown in the Control area of result window. 3. Swab Both Nostrils 5~10x 2. Tear o the seal of the sample tube. Positive Test Control Negative Test Control Invalid:

Test Control Test Control

-Take out the swab and hold with handle end.

-Tilt head back and gently insert swab tipabout 18mm until it is fully inside your nostril.

-Roll the swab tip 5~10 times around the inside walls of your nostril.

-The swab tip should be touching the walls of the nostril as you rotate.

-Repeat swab step in the other nostril.

>>>2 Positive:

If a clear visible line is seen in "Test" area of the result window, the nucleic acid of SARS-CoV-2 is detected in the sample, namely the result is positive. In positive results, sometimes the lines in "control" area could be light. In this case, the results are still valid. Negative:

If there is only one line presented in Control area and no visible line is seen in Test area, the nucleic acid of SARS-CoV-2 is not detected in the sample, namely the result is negative. Invalid:

If there is no visible line in both areas of the result window, test is failed and the result is invalid.

>>>3

[LIMITATIONS]

1. Persons who test positive with the GenuIN COVID-19 Rapid PCR Test should seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary. Positive results do not rule out bacterial infection or co-infec-

tion with other viruses. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider. 2. Inappropriate collection, transport and treatment of samples or low titer of pathogens may yield false negative result. 3. This product has been validated for current known mutations. Future mutations of target nucleic acid may yield false negative result. 4. Interference or amplication inhibitors other than those presented in [PERFORMANCE CHARACTERISTICS] 3.2 Interfering substances may yield false negative result. 5. Users are advised not to eat, drink or take unnecessary nasal drugs before self-testing. 6. Positive results do not rule out co-infection of bacteria or other viruses.

[PERFORMANCE CHARACTERISTICS]

1. Limit of detection 3000 copies/mL 2. Precision 2.1 Intra-batch precision Through the analysis on the results of repeatability samples from the same batch within 20 days, the detection rates of medium positive samples, weak positive samples and negative samples are all 100%, and the coincidence rate of negative samples is 100% (n 20). 2.2 Within-batch precision Through the analysis of the 20-day test results of the same operator in dierent batches, the 20-day detection rates of medium positive samples were all 100%, the detection rate of weak positive samples was 100%, and the coincidence rate of negative samples = 100% (n 20). 3. Specicity 3.1 Cross-reactivity Cross-reactivity (organisms tested in the absence of SARS-CoV-2) The specicity of the assay was evaluated in cross-reactivity testing using 25 commensal organisms. The cross-reactivity testing conrmed that none of the 25 organisms were cross reactive with the GenuIN COVID-19 Rapid PCR Test at the concentrations tested. The 25 commensal organisms are listed below:

Bacteria and viruses Bordetella pertussis Test concentration 10 bacteria/mL Bacteria and viruses Staphylococcus aureus Test concentration 10 bacteria/mL Respiratory Syncytial virus 10 copies/mL Chlamydia pneumoniae 10 ccu/mL Adenovirus Influenza A virus Influenza B virus Parainfluenza virus Epstein-Barr virus Coronavirus OC43 10copies/mL 10 copies/mL 10 copies/mL 10 copies/mL 10 copies/mL 10 copies/mL Rhinovirus Bocavirus Coronavirus NL63 Mycoplasma pneumoniae Coronavirus 229E Coronavirus HKU1 Legionella pneumophila 10 bacteria/mL MERS coronavirus Streptococcus pneumonia 10 bacteria/mL SARS CoV-1 10 copies/mL 10 copies/mL 10 copies/mL 10 ccu/mL 10 copies/mL 10 copies/mL 10 copies/mL 10 copies/mL Human Metapneumovirus 10 copies/mL Candida albicans 10 bacteria/mL Klebsiella pneumonia 10 bacteria/mL Staphylococcus epidermidis 10 bacteria/mL Haemophilus influenzae 10 bacteria/mL

3.2 Interfering substances The following substances have no eects on test results of this product. 3.2.1 Endogenous interfering substances: human plasma (1% v/v), human mucoprotein

(1% v/v), Human genome DNA (300ng). interfering substances: Phenylephedrine, Methotrexate, Sodium 3.2.2 Exogenous chloride, Beclomethasone, Dexamethasone, Flunisolide, Triamcinolone acetonide, Budesonide, Mometasone,Fluticasone,Histamine hydrochloride, Interferon , Zanamivir, Oseltamivir, Peramivir, Arbidol, Lopinavir, Ritonavir, Mupirocin, Levooxacin, Azithromycin, Ccephalosporin, Minocycline, Tobramycin, Azelastine, Vitamin A ointment, D-panthenol ointment, Biotin 4. Clinical performance Clinical performance of GenuIN COVID-19 Rapid PCR Test was determined by testing 109 positive and 508 negative specimens. 95.413% of individuals with positive real-time PCR tests were tested positive by GenuIN COVID-19 Rapid PCR Test. 99.803% of individuals with negative real-time PCR tests were tested negative by GenuIN COVID-19 Rapid PCR Test. And the total coincidence rate was 99.028%

GenuIN COVID-19 Rapid PCR Test Positive Negative Total RT-PCR Positive Negative 10 4 5 10 9 1 50 7 50 8 Total 10 5 51 2 61 7

>>>4

[EXPLANATION OF SYMBOLS]

IVD In vitro diagnostic medical device

Do not re-use Use-by date Caution Consult instructions for use Manufacturer Temperature limit LOT Batch code

Authorized representative in the European Community Keep dry Keep away from sunlight Do not use if package is damaged Date of manufacture Biological risks Contains sucient for <n> tests REF Catalogue number GenuIN Biotech LLC Address: 2270 Kraft Drive, Suite 1311, Blacksburg, VA 24060, USA Customer service: +01-540-605-9777 CAUTION - Investigational device. Limited by Federal law to investigational use.

[INSTRUCTION VERSION AND MODIFICATION DATE]

Approved on April 25, 2022. Version: A0 Relative Sensitivity: 95.413% (95%CI: 89.619% ~ 98.494%) Relative Specicity: 99.803% (95%CI: 98.908% ~ 99.995%) Accuracy: 99.028% (95%CI: 97.895% ~ 99.642%)

[PRECAUTIONS]

Please make sure to read this Instruction for Use carefully before use. This product is for auxiliary diagnosis in vitro only. It shall not be used as the only basis IVD for conrmed diagnosis. Please integrate other test methods or clinical symptoms for comprehensive consideration. Testing

This product is for disposable use. Please use it in accordance with this instruction. 1. Do not squeeze or press the test cassette while operating it. 2. Do not move the test cassette while testing. 3. Read test results within 30 minutes after adding the second bubble of buer A, otherwise it may yield false positive result. Operation The sample and other components contacted with the sample (e.g. used fragment of the tabletop, timer surface) may be a source of infection even if the test is negative and should be disinfected. Hands also should be washed or disinfected. Throughout the testing process, users are advised to wear masks and gloves to prevent infection. This test kit is a disposable in vitro diagnostic product. Any experimental wastes such as test cassettes, gloves, unused samples or reagent, etc., which have potential biological hazards, should be disposed of in accordance with biological safety regulations, environ-

mental protection regulations or medical waste regulations. 1. If the reagent mistakenly enters the eyes or mouth or sprays on the skin, please wash with clean water and seek help from doctors if necessary. 2. Please make sure there is no liquid or other matters axed on the outside surface of the test cassette before test. 3. Proper sample collection and sample handling are essential for correct results. Storage and use 1. This product must be stored at the condition as required in this instruction. 2. Do not use the expired product. 3. Before test, please make sure there is no rift on the test cassette or leakage of the liquid. 4. Please do not use this product for purposes not described in this instruction. 5. Please store the product properly and prevent children from touching it. Disposal 1. The pollution level of this kit is PD1 (No pollution or only dry non-conductive pollution). 2. The used product should be sealed in the zip-lock bag and be disposed of as the medical waste. Caution FCC Compliance Statement:

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) this device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. changes or modications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device complies with Part 18 of the FCC Rules. Operation is subject to the following two conditions:

(1)This device may not cause harmful interference,

(2) this device must accept any interference received, including interference that may cause undesired operation.

>>>5

>>>6

GenuIN COVID-19 Rapid PCR Test Note: 1. The label will attached to the back of the device. 2. This would be a plastic label with a permanent adhesive.

Ustar Biotechnologies (Hangzhou) Ltd. Date: August 25,2022 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 To whom it may concern:

I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to:

a) b) comply with the relevant provisions of the certification program;

make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;

make claims regarding certification only in respect of the scope for which certification has been granted;

do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;

upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;

use certification only to indicate the products are certified as being in conformity with specified standards;

g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;

h) ensure that any reference to our product certification in communication media such as__ jj #

documents, brochures or advertising, complies with the requirements of the Certification Division;

i) keep arecord of all complaints made known to us relating to the products compliance with requirements of the relevant standard and to make these records available to the when requested;

j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;

k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Signed by:

Company Name: UstarfB}et Contact Name: Hong fy Alta

Ustar Biotechnologies (Hangzhou) Ltd. Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject:

Request for Confidentiality FCC ID:

2A8FMU202025-1 To Whom It May Concern:

Pursuant to the provisions of Sections 0.457 and 0.459 of the Commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Schematic Diagram Block Diagram Theory of Operation Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Company Name: Ustar Biotechnologies (Hangzhou) Ltd. Contact Name: Hongfeng Zhang Title of Person: Registration Manager Address: 6/F, Building 2,611 Dongguan Road, Binjiang District, Hangzhou,Zhejiang, 310053 China Date: August 25,2022