Product name
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal
Certificate
CE1434
Epidemiology
Coronavirus Disease 2019(COVID-19), is a pneumonia caused by infection with a novel coronavirus named as Severe Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2). SARS-CoV-2 is a novel coronavirus in β genus, enveloped particles in round or oval, with a diameter from 60 nm to 140 nm. Human is generally susceptible to SARS-CoV-2. The main sources of infection are the confirmed COVID-19 patients and asymptomatic carrier of SARSCoV-2
[1].
Features
● Rapid: Read results in 15 minutes.
● Easy to use: Only 3 steps.
● Convenient: For self-test, home test.
● Room temperature: Transportation & storage at 4-30℃ for 24 months.
● Accuracy: High sensitivity & specificity.
Clinical study
The performance of Antigen Detection Kit was evaluated in 554 patients of nasal swabs collected from symptomatic suspects of COVID-19 within 7 days post symptom onset compared to RT-PCR assay. The performance of the SARS-CoV-2 Ag Test Kit is as follows:
| SARS-CoV-2 Virus Antigen (investigational reagent) |
RT-PCR reagent |
Total |
| Positive |
Negative |
| Positive |
97 |
0 |
97 |
| Negative |
7 |
450 |
457 |
| Total |
104 |
450 |
554 |
| Sensitivity |
93.27% |
95.0% CI |
86.62% - 97.25% |
| Specificity |
100.00% |
95.0% CI |
99.18% - 100.00% |
| Total |
98.74% |
95.0% CI |
97.41% - 99.49% |
Technical Parameters
| Storage temperature |
4℃-30℃ |
| Sample type |
Nasal swab samples |
| Shelf life |
24 months |
| Auxiliary instruments |
Not required |
| Extra Consumables |
Not required |
| Detection time |
15-20 mins |
| Specificity |
There is no cross-reactivity with pathogens such as human Coronavirus ( HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63), Novel influenza A H1N1 (2009), seasonal influenza A (H1N1, H3N2, H5N1, H7N9), Influenza B (Yamagata, Victoria), Respiratory syncytial virus A/B, Parainfluenza virus(1, 2 and 3), Rhinovirus (A, B, C), Adenovirus (1, 2, 3, 4,5, 7, 55). |
Work Flow
1. Sampling
● Gently insert the entire soft tip of the swab (usually 1/2 to 3/4 of an inch) into one nostril, Using medium pressure, rub the swab against all the inside walls of your nostril. Make at least 5 big circles. And each nostril must be swabbed for about 15 seconds.Using the same swab, repeat the same in your other nostril.
● Sample dissolving. Dip the swab completely into the sample extraction solution; Break the swab stick at the breaking point, leaving the soft end in the tube. Screw on the cap, invert 10 times and put the tube at a stable place.
2. Perform the test
Put 3 drops of the processed extracted sample into the sample hole of the detection card, screw the cap.
3. Read the result (15-20mins)
Precautions:
1. Do not read the result after 20 mins.
2. After opening, please use the product within 1 hour.
3. Please add samples in strict accordance with the instructions.
Key Components
| Catalogue Number |
Specification |
Components |
Quantity |
| HWTS-RT062I |
1 test/kit |
Test Card |
1 |
| Sample Extraction Solution |
1 |
| Disposable Swab |
1 |
| Package Insert |
1 |
| HWTS-RT062IA |
5 tests/kit |
Test Card |
5 |
| Sample Extraction Solution |
5 |
| Disposable Swab |
5 |
| Package Insert |
1 |
| HWTS-RT062IB |
10 tests/kit |
Test Card |
10 |
| Sample Extraction Solution |
10 |
| Disposable Swab |
10 |
| Package Insert |
1 |
| HWTS-RT062IC |
20 tests/kit |
Test Card |
20 |
| Sample Extraction Solution |
20 |
| Disposable Swab |
20 |
| Package Insert |
1 |
Reference
[1] New Coronavirus Pneumonia Diagnosis and Treatment Plan. (Eighth Edition), National Health Office Medical Letter [2020] No. 680