Shenzhen Wensidun Technology Co., Ltd.
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Professional Covid 19 Ag Rapid Test Kit 25 Tests/Kit Results in 15 min
SPECIMEN COLLECTION
Correct sample collection is the most important step. Select one of the methods then proceed with the test procedure.
1) Anterior-nasal swab (frontal nose)
Make sure to collect sufficient nasal secretions with the swab. It is recommended to blow your nose first.
1. Carefully insert the swab into the patient's nostril. The swab tip should be inserted 2-4 cm into the nostril until resistance is met.
2. Swab along the mucosa in the nostril to ensure that both mucus and cells are collected.
3. Remove the swab from the nostril while gently rotating it between your fingers.
2) Nasopharyngeal swab (nose-throat)
1.Tilt the patient's head slightty backwards. Hold the swab like a pen and insert it through the nostril parallel to the palate.
2. While inserting,gently rub and roll the swab.Once you feel the pharyngeal resistance, stop and allow the swab to absorb secretions.
3. Slowly and gently remove the swab outward while gently rotating it
between your fingers.
3)Oropharyngeal Swab Specimen collection
1. Let the patient's head tilt slightly, open mouth and make "ah"sounds.
2. Exposing the pharyngeal tonsils on both sides.
3. Hold the swab and wipe the pharyngeal tonsils on both sides of the patient with moderate force back and forth for at least 3 times.
For best results the nasopharyngeal method is recommended.
Clinical Performance
The clinical presentation of the rapid SARS-CoV-2 antigen test was determined in a prospective, randomized, single-blind study. Within 5 days of the onset of suspected symptoms, 310 nasopharyngeal specimens were collected from symptomatic and asymptomatic patients. The performance of this kit was compared to the results of commercially available molecular tests. The test was found to have 98% sensitivity and 100.00% specificity. The accuracy is 99.35%.
For the anterior nasal swab method, a total of 263 samples were collected for testing. The test has a sensitivity of 96.8% and a specificity of 100.00%. The accuracy is 98.48%.
| Greenspring SARS-COV2-Antigen-rapidtest (nasopharyngeal) | PCR-Comparator | Total | |
| Positive | Negative | ||
| Positive | 98 | 0 | 98 |
| Negative | 2 | 210 | 212 |
| Total | 100 | 210 | 310 |
| Sensitivity | 98% (95% Cl: 97,12-99,98%) | ||
| Specificity | 100% (95% Cl: 98,12-99,99%) | ||
| Accuracy | 99,35% | ||
| Greenspring SARS- COV2-Antigen-rapidtest (anterior nasal)
| PCR-Comparator | Total | |
| Positive | Negative | ||
| Positive | 121 | 0 | 121 |
| Negative | 4 | 138 | 142 |
| Total | 125 | 138 | 263 |
| Sensitivity | 96,8% (95% Cl: 91,52-98,97%) | ||
| Specificity | 100% (95% Cl: 96,62-100%) | ||
| Accuracy | 98,48% (95% Cl: 96,17-100%) | ||
TEST PERFORMANCE
After sample collection, perform the test as follows:
1. Insert the swab sample into the extraction tube and dip it up and down in the liquid. Rotate the swab several times during this process.
2. While removing the swab squeeze the sides of the tube to extract the remaining liquid out of the swab.
3. Place the dropper tip firmly on the extraction tube and mix the liquid thoroughly.
4. Dispense 3 drops (approximately 100μL) into the sample well of the test cassette via the dropper tip.
5. Interpret the test results after 15 minutes. Do not interpret the results after 20 minutes.
Package and Specification
25 tests/kit (1 test/bag x 25 bags)
Product Advantages
1. Nasopharynx swab specimen, non-invasive
2. Very simple to use
3. Convenient, no devices required
4. Rapid, results within 15 minutes
5. Cost-efficient
Clinical report from local CDC
Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.
Component
| test/bag | 25 bags |
| 0.5mL extraction buffer | 25 bottles |
| Sterile single-use sampling swab | 25 pieces |
| Package insert | 1 piece |
Using Direction
Interpretation of the test result
Positive: The presence of two lines in the results window as control line C and test line T indicates a positive result.
Negative: Colored lines appear in control area C. No visible colored lines appear in the test strip area T. A negative result does not rule out viral infection with SARS-CoV-2, and in the case of COVID-19, the suspicion should be confirmed by molecular diagnostic methods.
Invalid: Control lines do not appear. Insufficient sample volume or improper handling is the most likely reason for the control line not appearing. Check the program and repeat the test with a new test cassette.
Storage and Stability
1. Store in a sealed bag at 2~30℃ until the shelf life, and the validity period is tentatively set for 12 months. Do not freeze.
2. After the test cassette is taken out of the aluminum foil bag, it should be used within 1 hour.
3. Keep away from sunlight, humidity and heat sources.
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.