Active Member
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Address: Vanke Tianyu Garden,B2-1010, Unit B, Building 9 Longcheng Street Longgang District Shenzhen, China
Contact name:Zhang
Shenzhen Wensidun Technology Co., Ltd. |
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SARS-CoV-2 Antigen Self Test Kit 1 5 10 25 Tests/Kit CE for Nasal Swab
Issued Date: 2022-04-08
Intended Use
The SARS-CoV-2 Antigen Rapid Test(Colloidal Gold) is an
immunochromatographic test for the rapid qualitative detection of
SARS-CoV-2 nucleocapsid protein antigens in human nasal swabs. It
is intended to be used as a self-test during the acute phase of
infection in cases of suspected COVID-19. The SARS-CoV-2 Antigen
Rapid Test cannot be used as a basis for diagnosis or exclusion of
SARS-CoV-2 infection. Children under 18 years of age must be
supervised by adults when performing the test.
Summary
COVID-19 is an acute respiratory infectious disease caused by the
novel coronavirus SARS-CoV-2. Humans are generally susceptible to
it. Currently, patients infected with the novel coronavirus are the
main source of infection; asymptomatically infected people may also
be a source of infection. Symptoms include fever, fatigue, loss of
smell and/or taste, and dry cough. In some cases symptoms may
include a stuffy or runny nose, sore throat, muscle aches, and
diarrhea may occur.
Materials Provided
| Component | Description | Specification | |||
1 test/kit Ref.GF102BS1 | 5 test/kit Ref.GF102BS5 | 10 test/kit Ref.GF102BS10 | 25 test/kit Ref.GF102BS25 | ||
| Test cassette | Foil ouched test device containing one reactive strip. | 1 | 5 | 10 | 25 |
| Sterile swab | For sample collection and transfer. | 1 | 5 | 10 | 25 |
| Inside page | Instructions for use. | 1 | 1 | 1 | 1 |
| Extraction buffer | Dissolve the sample | 1 | 5 | 10 | 25 |
| The certificate of conformity | 1 | 1 | 1 | 1 | |
| Packages with holes | Be used as tube stand (optional). | 1 | 1 | 1 | 1 |
To perform the test correctly everytime should require the Clock or timer, however we don’t provide the clock or timer originally.
Performance data
For the anterior nasal swab method, 645 specimens were collected.
| Vitassay qPCR SARS-CoV-2 | Total | |||
| Positive | Negative | |||
| SARS-CoV-2 Antigen Rapid Test kit | Positive | 238 | 0 | 238 |
| Negative | 7 | 400 | 407 | |
| Total | 245 | 400 | 645 | |
| Statistic | Value | 95% CI |
| Sensitivity | 97.14% | 94.20% to 98.84% |
| Specificity | 99.99% | 99.08% to 100% |
Detection Limit
The limit of detection (LOD) for the SARS-CoV-2 Antigen Rapid Test
is 4 x 102 TCID50/mL.
| Matrix | LOD Concentration TCID50/mL | Number of Positive/ Total | %Detected |
A viral sample inactivated by gamma irradiation | 4 x 102TCID50/mL | 20/20 | 100% |
Cross Reactivity and Microbial Interference
The cross-reactivity with the following microorganisms was
examined. Samples that tested positive for the following
microorganisms were negative when tested with the SARS-CoV-2
Antigen Rapid Test (Colloidal Gold). The microbial interference
study evaluated whether microorganisms possibly contained in
clinical samples interfere with the detection capability of the kit
which may lead to false negative results. Each microorganism was
tested in the presence of a fabricated SARS-CoV-2 positive sample.
No cross-reactivity or interference with the microorganisms listed
in the table below was found.
| No. | Microorganism | Final Test Concentration |
| 1 | SARS-Cov recombinant protein | 2.5 mg/mL |
| 2 | MERS-Cov recombinant protein | 2.07 mg/mL |
| 3 | Adenovirus(Type 1) | 1.0×107 pfu/mL |
| 4 | Adenovirus(Type 3) | 1.0×107 pfu/mL |
| 5 | Coronavirus(229E) | 1.0×107 pfu/mL |
| 6 | Coronavirus(HKU1) | 1.0×107 pfu/mL |
| 7 | Coronavirus(NL63) | 1.0×107 pfu/mL |
| 8 | Coronavirus(OC43) | 1.0×107 pfu/mL |
| 9 | Influenza A Seasonal H1N1 | 1.0×107 pfu/mL |
| 10 | Influenza B Yamagata | 1.0×107 pfu/mL |
| 11 | Legionella pneumonila | 1.0×107 pfu/mL |
| 12 | MERS | 1.0×107 pfu/mL |
| 13 | Mycobacterium tuberculosis | 1.0×107 pfu/mL |
| 14 | Mycoplasma pneumoniae | 1.0×107 pfu/mL |
| 15 | Parainfluenza virus (Type 1) | 1.0×107 pfu/mL |
| 16 | Respiratory syncytial virus | 1.0×107 pfu/mL |
| 17 | Rhinovirus(Group A) | 1.0×107 pfu/mL |
| 18 | Rhinovirus(Group B) | 1.0×107 pfu/mL |
Interference
The following interfering substances have no impact on SARS-CoV-2
Antigen Rapid Test (Colloidal Gold).
| No. | Interfering Substance | Final Test Concentration |
| 1 | Mucin | 0.54% |
| 2 | Menthol | 1.4 mg/mL |
| 3 | Whole Blood | 5% |
| 4 | Triamcinolone acetonide | 1 ng/mL |
| 5 | Tobramycin | 5 μg/mL |
| 6 | Levofloxacin | 1.5 μg/mL |
| 7 | Mupirocin | 12 mg/mL |
| 8 | Oxymetazoline | 9%v/v |
| 9 | Nasal Spary | 16%v/v |
| 10 | Dexamethasone | 0.5 μg/mL |
Hook Effect
No high dose hook effect was observed when tested with up to a concentration of 1.3 x 106 TCID50/mL of heat inactivated SARS-CoV-2 virus.
Warnings And Important Information
1. The test is designed for external use outside human body only. Please do not ingest. Avoid skin and eye contact with the buffer liquid.
2. Failure to follow the instructions may affect the test result. The final diagnosis should be confirmed by a physician.
3. Keep it out of reach of children.
4. Persons with reduced vision or mobility should ask for assistance.
5. Do not use the test if test components are damaged.
6. Use only the materials supplied with this test. Do not reuse the test or test components.
7. The test should be performed immediately, latest one hour after opening the foil pouch (at 20-30°C, humidity<60%).
Preparation
Read the instructions for use carefully before performing the test.
Blow your nose and then wash your hands thoroughly with soap or
disinfect them with disinfectant. Keep the test cassette and
components at room temperature (15°C to 30°C) before performing the
test. Place all the materials supplied on a clean, dry and flat
surface.
Sampling In The Nose
Please follow the instructions on the next page step by step for
sampling test.
Antigen Self Test Kit Test Procedure
1. Blow your nose. Wash or disinfect your hands. Remove the test
cassette by tearing open the foil pouch and place it in front of
you.
2. Tear off the seal of extraction buffer tube, Press in the
perforated hole on the top of the packaging and use the hole as a
tube stand.
3. Remove the swab. Do not touch the sterile tip of the swab.
Instead, grasp the swab by the handle. Insert the swab about 2.5 cm
deep into your nostril until you feel resistance.
4. Collect sample from left and right nostrils with the same swab:
Rub the swab against the inner wall of the nose and turn it at
least 5 times to ensure sufficient sample is collected. Repeat the
process in the other nostril.
Note: Children under 15 years of age (at least 2 years old), and
people including the elderly and sick who are unable to perform the
test themselves should be tested by another adult. To sample a
child, insert a cotton swab into one of their nostrils until you
feel some resistance (about 2 cm). Rotate the swab against the
nasal wall 5 times. Repeat the sampling process by removing the
swab and inserting the same swab into the other nostril. If the
child feels any pain, do not continue the test.
5. Dip a cotton swab into the tube and make sure it is well mixed
with the extract by stirring and dipping up and down at least 5
times. Let the cotton swab soak for a minute.
6. Slowly pull the swab out of the tube while gently squeezing the
sides of the tube to retain as much liquid in the tube as possible.
7. Place the dropper tip firmly on the extraction buffer tube and
mix the liquid thoroughly.
8. Drop 3 drops into the sample well (S) on the test card.
9. Interpret the test result between 15-20 minutes. The result
after 20 minutes is invalid.
Interpretation Of The Test Result
Check whether a line is visible at the control line (C). The color
thickness of the control line (C) is irrelevant. If it is not
visible, the test was not performed correctly and a new test with a
new test set must be performed.
Positive Test Result
If a colored line is visible in the test line region (T) and a
colored line is visible in the control line region (C), indicating
positive test result. This means that SARS CoV-2 antigens are
detectable in your nasal sample and indicates with high probability
of COVID-19 infection.
Please stay home and call your physician or local health
department. Follow local guidelines for self isolation and have a
PCR confirmatory test performed.
*Note: The thickness of the line is irrelevant; any reddish line in
the test line (T) should be interpreted as a positive test result.
A positive test result must be confirmed by molecular diagnostics
(e.g. PCR test).
Negative Test Result
If only a colored line is visible in the area of the control line
(C), but not at the test line (T), the test result is negative.
This indicates that no or too few SARS-CoV-2 antigens are present
in the nasal sample and that there is probably no infection with
the SARS-CoV-2 virus.
Continue to follow applicable rules regarding contact with others and applicable protective measures. In case of suspicion, repeat the test using new test kit, as SARS-CoV-2 virus cannot be accurately detected at all stages of infection. A negative result does not rule out infection with SARS CoV-2 and should be confirmed by PCR testing if suspected.
Invalid Test Result
If no line is visible in the control line (C) or only one line is
visible in the test line area (T), indicating the test is not
performed correctly and the result is invalid. It is important to
follow the instructions for the test carefully. Please repeat the
test with new sample and new test set.
Storage and disposal
Store at room temperature (2-30°C or 35.6-86 T).
Shelf life 12 months (from production date to expiration date).
Test cassettes must be stored in airtight foil pouches until use.
Do not use after expiration date.
Waste from used tests should be disposed of according to local
regulations.
Q1: When will it be shipped?
A1: We will ship the goods for you as soon as possible within 7
working days after receiving the payment. (In the event of the
epidemic and other external factors, there may be delays in
shipping)
Q2: Does it support OEM/ODM?
A2: It can be supported, but the specific quantity needs to be more
than 100,000 pieces to facilitate customized products.
Q3: How is your factory doing in terms of quality control?
A3: We have ISO9001 and ISO13485 certified by the state. Our
production process is in accordance with the standard process,
which can ensure that the quality of the products is optimal.
Q4: How is after-sales service provided?
A4: We provide professional online technical after-sales service.
We can provide you with one-on-one guidance in the form of video,
phone calls, etc.
Q5: What is the payment method?
A5: We receive payment by T/T.
Q6: How to ship?
A6: By obtaining quotations from our many cooperative carriers,
choose the best way to ship for you, or you can ship according to
your requirements.
