Use Instruction
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>>>5>>>4
RT-PCR
Total
10 4 1
10 5
5 50 7
51 2
10 9 50 8
61 7
[PRECAUTIONS]
Please make sure to read this Instruction for Use carefully before use.
Relative Sensitivity: 95.413% (95%CI: 89.619% ~ 98.494%)
Relative Specificity: 99.803% (95%CI: 98.908% ~ 99.995%)
Accuracy: 99.028% (95%CI: 97.895% ~ 99.642%)
GenuIN COVID-19 Rapid PCR
Test
Positive
Negative
Total
NegativePositive
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 affixed on the outside surface of the
test cassette before test.
3. Proper sample collection and sample handling are essential for correct results.
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 buffer A,
otherwise it may yield false positive result.
This product is for auxiliary diagnosis in vitro only. It shall not be used as the only basis
for confirmed diagnosis.
Please integrate other test methods or clinical symptoms for comprehensive consideration.
Operation
Testing
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.
Storage and use
Disposal
Caution
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.
[EXPLANATION OF SYMBOLS]
LOT
Use-by date
Caution
Temperature limit
Authorized representative in
the European Community
Keep away from sunlight
Date of manufacture
Do not re-use
Consult instructions for use
Manufacturer
Batch code
Keep dry
Do not use if package is damaged
Biological risks
IVD
In vitro diagnostic medical device
Catalogue numberContains sufficient for <n> tests
REF
[INSTRUCTION VERSION AND MODIFICATION DATE]
Approved on April 25, 2022. Version: A0
3.2 Interfering substances
The following substances have no effects 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).
3.2.2 Exogenous interfering substances: Phenylephedrine, Methotrexate, Sodium
chloride, Beclomethasone, Dexamethasone, Flunisolide, Triamcinolone acetonide,
Budesonide, Mometasone,Fluticasone,Histamine hydrochloride, Interferon α, Zanamivir,
Oseltamivir, Peramivir, Arbidol, Lopinavir, Ritonavir, Mupirocin, Levofloxacin, 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%
Bacteria and viruses
Bordetella pertussis
Respiratory Syncytial virus
Adenovirus
Influenza A virus
Influenza B virus
Parainfluenza virus
Epstein-Barr virus
Coronavirus OC43
Legionella pneumophila
Streptococcus pneumonia
Human Metapneumovirus
Klebsiella pneumonia
Haemophilus influenzae
Test concentration
10⁶ bacteria/mL
10⁶ copies/mL
10⁶copies/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ bacteria/mL
10⁶ bacteria/mL
10⁶ copies/mL
10⁶ bacteria/mL
10⁶ bacteria/mL
Bacteria and viruses
Staphylococcus aureus
Chlamydia pneumoniae
Rhinovirus
Bocavirus
Coronavirus NL63
Mycoplasma pneumoniae
Coronavirus 229E
Coronavirus HKU1
MERS coronavirus
SARS CoV-1
Candida albicans
Staphylococcus epidermidis
/
Test concentration
10⁶ bacteria/mL
10⁶ ccu/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ ccu/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ copies/mL
10⁶ bacteria/mL
10⁶ bacteria/mL
/
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 modifications not expressly approved by the party responsible for compliance
could void the user’s 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 off 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 different from that to which the receiver
is connected.
—Consult the dealer or an experienced radio/TV technician for help.
IVD
[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 amplification 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 different 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. Specificity
3.1 Cross-reactivity
Cross-reactivity (organisms tested in the absence of SARS-CoV-2)
The specificity of the assay was evaluated in cross-reactivity testing using 25 commensal
organisms. The cross-reactivity testing confirmed 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:
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.
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.
GenuIN Biotech LLC