LUNGENE Covid-19 Antigen Rapid Test Cassette Instructions

Covid-19 Antigen Rapid Test Cassette

COVID-19 Antigen Rapid Test Cassette
English For in vitro diagnostic use only.
[INTENDED USE] The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasopharyngeal swab and oropharyngeal swab during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.
The COVID-19 Antigen Rapid Test Cassette is intended for use by medical professionals or trained operators who are proficient in performing lateral flow tests. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation.
[SUMMARY] The novel coronaviruses (SARS-CoV-2) belong to the genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. 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.
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[WARNINGS AND PRECAUTIONS] For in vitro diagnostic use only.
For healthcare professionals and individuals trained in point of care settings.
Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19.

Do not use this product after the expiration date. Please read all the information in this leaflet before performing the test. The test cassette should remain in the sealed pouch until use. All specimens should be considered potentially hazardous and handled in
the same manner as an infectious agent. The used test cassette should be discarded according to federal, state
and local regulations.
[COMPOSITION] Materials Provided 25 Test Cassettes: each cassette with desiccant in individual foil pouch 25 Extraction Reagents: ampoule containing 0.3mL of extraction reagent 25 Sterilized Swabs: single use swab for specimen collection 25 Extraction Tubes 25 Dropper Tips 1 Work Station 1 Package Insert Materials Required but not Provided Timer
[STORAGE AND STABILITY] SSttoorree iansthpeascekaalgeeddpoinucthhea 4s- e3a0ledopr o4u0c-8h6at. tTehmepkeitraistusrteab(l4e within the expiratio).n Tdhaete kpirtinitsedstoanbltehewlaithbienlintgh.e expiration date printed on the
lOnce the pouch has been opened, the test should be performed within one Ohonucre. Poproelonntgheedpeoxupcohs,utrheetotehsottsahnoduhldumbeiduesnevdirownimtheinntosnweilhl coauur.sPe rporloodnugcetd edxepteorsiautrieont.o hot and humid environment will cause product deterioration.
The LLOOTT aanndd the expiratioionndate wereereprpinritnetdedon the lablelingi.ng.
[SPECIMEN] Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield false results; therefore, training in specimen collection is highly recommended due to the importance of specimen quality to obtain accurate test results. Acceptable specimen type for testing is a direct swab specimen or a swab in viral transport media (VTM) without denaturing agents. Prepare the extraction tube according to the Test Procedure and use the sterile swab provided in the kit for specimen collection. Nasopharyngeal SwabSpecimen Collection
1. Remove the swab from the package.
2. Tilt patient’s head back about 70°.
3. Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. (Swab should reach depth equal to distance from nostrils to outer opening of the ear.) Gently rub and roll the swab. Leave swab in place for
1/2

several seconds to absorb secretions.
4. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the tip of swab is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril. Oropharyngeal Swab Specimen Collection
Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums.
Specimen Transport and Storage Do not return the swab to the original swab packaging. Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Specimen collected may be stored at 2-8 for no more than 24 hours; Store at -70 for a long time, but avoid repeated freeze-thaw cycles.
[TEST PROCEDURE] Note: Allow the test cassettes, reagents and specimens to equilibrate to room temperature (15-30 or 59-86) prior to testing. Put an extraction tube on the work station. Unscrew the lid of an extraction reagent. Add all of the extraction
reagents into an extraction tube. Sampling refers to section `Specimen Collection’.
Direct Swab Test Procedure 1. Insert the swab specimen into the extraction tube which contains
extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube. Leave the swab in the extraction tube for one minute. 2. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as test sample. 3. Cover the extraction tube with a dropper tip tightly.
4. Remove the test cassette from the sealed pouch. 5. Reverse the specimen extraction tube, holding the tube upright, transfer 3
drops (approximately 100L) slowly to the specimen well(S) of the test 109155104

cassette, then start the timer. 6. Wait for colocorelodrelindelisnetos atoppaepapre. aInr taeprppreeatrt.hIentteersptreretsthueltstest 1re5smulitns uatfetesr 15 minDuotenso. tDreoandorterseualdtsreasftuelrts20afmteirn2u0tems.inutes.
Swab in Viral Transport Media (VTM) Test Procedure 1. Insert the swab specimen into the transport tube containing a maximum
of 3 mL VTM without denaturing agents. 2. Mix the specimen stored in VTM by vortexing. 3. Transfer 300L of the VTM solution containing specimen into the
extraction tube which contains extraction reagent with a calibrated micropipette. Homogeneous mixture by pipetting up and down. 4. Cover the extraction tube with a dropper tip tightly, and let the extracted solution stand for one minute.
5. Follow Steps 4 ­ 6 of the Direct Swab Test Procedure above.
[INTERPRETATION OF RESULTS]

procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

[LIMITATIONS]

The product is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antigen of the specimens.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.

A physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.

A negative result can occur if the quantity of SARS-CoV-2antigens present in the specimen is below the detection threshold of the assay, or the virus has undergone minor amino acid mutation(s) in the target epitope region recognized by the monoclonal antibodies utilized in the test.

[PERFORMANCE CHARACTERISTICS]

Clinical Performance

The clinical performance of COVID-19 Antigen Rapid Test Cassette was established in prospective studies with nasopharyngeal swabs collected from 770 individual symptomatic patients (within 7 days of onset) and asymptomatic patients who were suspected of COVID-19.
Summary data of COVID-19 Antigen Rapid Test as below: The RT-PCR cycle threshold (Ct) is the relevant signal value. Lower Ct value indicate higher viral load. The sensitivity was calculated for the different Ct value range (Ct value33 and Ct value37).

COVID-19 Antigen

RT-PCR (Ct value33)

Positive

Negative

CLUNGENE®

Positive Negative

145 3

2 593

Total

148

595

PPA (Ct33):98.0% (145/148), (95%CI: 94.2%99.3%)

NPA: 99.7% (593/595), (95%CI: 98.8%99.9%)

Total
147 596 743

Positive

Two lines appear. One colored line appears at the control region (C), and another colored
line appears at the test region (T), irregard-
less of the intensity of the test line.

Negative

One colored line appears at the control region (C), and no line appears at the test region (T).

Invalid

Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test cassette. If the problem persists, discontinue using the lot immediately and contact your local distributor.

[QUALITY CONTROL] A procedural control is included in the test. A colored line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct

COVID-19 Antigen

RT-PCR (Ct value37)

Positive

Negative

CLUNGENE®

Positive Negative

161 14

2 593

Total

175

595

PPA (Ct37):92.0% (161/175), (95%CI: 87.0%95.2%)

NPA:99.7% (593/595), (95%CI: 98.8%99.9%)

PPA – Positive Percent Agreement (Sensitivity) NPA – Negative Percent Agreement (Specificity)

Total
163 607 770

Limit of Detection (Analytical Sensitivity)
The study used cultured SARS-CoV-2 virus (Isolate Hong Kong/VM20001061/2020, NR-52282), which is heat inactivated and spiked into nasopharyngeal swab specimen. The Limit of Detection (LoD) is 5.7 ×102 TCID50/mL.

Cross Reactivity (Analytical Specificity)
Cross reactivity was evaluated by testing 32 commensal and pathogenic microorganisms that may be present in the nasal cavity.
No cross-reactivity was observed with recombinant MERS-CoV NP protein when tested at the concentration of 50 g/mL.

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No cross-reactivity was observed with the following viruses when tested at the concentration of 1.0×106 PFU/mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A(H3N2), Influenza B(Yamagata), Influenza B(Victoria), Adenovirus (type 1, 2, 3, 5, 7, 55), Human metapneumovirus, Parainfluenza virus (type 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.
No cross-reactivity was observed with the following bacteria when tested at the concentration of 1.0×107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (group A), Streptococcus pneumoniae, Candida albicans,Staphylococcus aureus.

Interference

The following potential interference substances were evaluated with the

COVID-19 Antigen Rapid Test Cassette at the concentrations listed below

and were found not to affect test performance.

Substance

Concentration

Substance

Concentration

Mucin

2%

Whole blood

4%

Benzocaine

5 mg/mL

Menthol

10 mg/mL

Saline nasal spray

15%

Phenylephrine

15%

Oxymetazoline

15%

Histamine dihydrochloride

10 mg/mL

Tobramycin

5 g/mL

Mupirocin

10 mg/mL

Oseltamivir phosphate 10 mg/mL

Zanamivir

5 mg/mL

Arbidol

5 mg/mL

Ribavirin

5 mg/mL

Fluticasone propionate

5%

Dexamethasone

5 mg/mL

Triamcinolone

10 mg/mL

High-dose Hook Effect
The COVID-19 Antigen Rapid Test Cassette was tested up to 1.0×105.67 TCID50/mL of inactivated SARS-CoV-2 and no high-dose hook effect was observed.

Hangzhou Clongene Biotech Co., Ltd. No.1 Yichuang Road, Yuhang Sub-district, Yuhang District, 311121 Hangzhou, China
Shanghai International Holding Corp.GmbH (Europe) Eiffestrasse 80, D-20537 Hamburg, Germany

Index of Symbol

Do not reuse 4 30 Store between 4-30

For in vitro diagnostic use only Consult instructions for use

Lot number

Contains sufficient for tests

Use by

Keep away from sunlight

Keep dry Manufacturer

Do not use if package is damaged
Authorized representative in the European Community

Version No.: 4.0 Effective Date: January 13, 2021

109155104

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