Use Instruction
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GenuIN COVID-19 Rapid PCR Test
Instruction for Use
[PRODUCT NAME]
GenuIN COVID-19 Rapid PCR Test
[PACKING SPECIFICATION]
IVD
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 amplification and the nucleic acid lateral flow assay to
detect and identify specific sequences of SARS-CoV-2 RNA. This assay is similar to a PCR
test in that it utilizes a molecular amplification 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 first week after symptom onset. Individuals diagnosed with COVID-19
within 3 months are recommended to first 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 difficult to differentiate 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 amplification (CPA) and nucleic acid lateral flow to
qualitatively detect the specific sequence of SARS-CoV-2 RNA (genes ORF1ab and N). With
the self-driven heating module, the assay can perform isothermal amplification reactions
through specific amplification primers, probes, RNA reverse transcriptase, and DNA
polymerase with high strand displacement activity. The viral RNA was first transferred to
DNA with RNA reverse transcriptase and then amplified with DNA polymerase. The assay
consists of a module preloaded with nucleic acid amplification reagent and corresponding
lateral flow strip.
The paper strip is used for rapid detection of nucleic acid amplification products by
[MATERIALS PROVIDED]
Materials Provided
Disposable sampling swab
Sample tube
(Prefilled with lysis buffer)
Dripper
Buffer A (Prefilled in bubbles)
Test cassette
Zip-lock bag
No.
1
2
3
4
5
6
Quantity
1
1
1
2
1
1
chromatographic double antibody sandwich method. Biotin and FAM probe are modified
at both ends of one specific primer in the reaction system. For positive samples, due to
capillary forces, reported nucleic acid fragment flow from sample pad side to detection
pad, then the FAM end of nucleic acid will combine with colloidal gold particles and binds
specifically 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 modified 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.
Note:
1. Do not mix materials from different lots.
2. Do not reuse the materials of the assay.
[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 affected 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
样本袋
SPECIMEN BAG
Disposable
sampling swab
Buffer A
Sample tube
Dripper
Test cassetteZip-lock bag
-Take out all components from the package.
2. Tear off the seal of the sample tube.
3. Swab Both Nostrils
5~10x
-Take out the swab and hold with handle end.
-Tilt head back and gently insert swab tip（about
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.
Insert swab into the sample tube and make sure the
swab tip is fully immersed in the lysis buffer.
-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.
15x
4. Load Sample and Run Test
-Take out the test cassette and place it on a clean flat
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
buffer into the sample hole.
-Open one bubble of buffer A and add all of it into the
sample hole.
-Pull out the Type-C connector and open the cap
of sample hole.
-Open another bubble of Buffer A and add all of
it into the hole, then close with the cap again.
-The result can be read in 5 min.
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 Buffer A.
-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.
[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 confirm the lateral flow worked. The result of internal control is
shown in the “Control” area of result window.
Test Control
Invalid:
Negative：
Control
Test
Positive：
Test Control
Control
Test
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.