LUNGENE Covid-19 Antigen Rapid Test Cassette Instructions
- June 6, 2024
- LUNGENE
Table of Contents
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
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Tdhaete kpirtinitsedstoanbltehewlaithbienlintgh.e expiration date printed on
the
lOnce the pouch has been opened, the test should be performed within one
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will cause product deterioration.
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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
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cassette, then start the timer. 6. Wait for colocorelodrelindelisnetos
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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.
2/2
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
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
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