CE Approved PocRoc® SARS-CoV-2 / Influenza A+B/RSV Antigen Combo Rapid Test Kit (Colloidal Gold)
Product Highlight:
- CE Certificated
- Rapid Result: 15 mins
- Convenient Storage: 4~30℃
- No cold-chain transportation needed
- Shelf Life: 24 months
Product Description
Intended Use:
The PocRoc® SARS-CoV-2 / Influenza A+B/RSV Antigen Combo Rapid Test Kit is a lateral flow immunoassay intended for in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Respiratory Syncytial Virus, Influenza A virus and/or Influenza B virus directly from nasal swab specimens.
This kit is intended for self-test as a rapid test for novel coronavirus (SARS-CoV-2), RSV, Influenza A and/or Influenza B infection by laypersons within the first four days of symptoms onset.
Specification:
| Product Name |
PocRoc® SARS-CoV-2 / Influenza A+B/RSV Antigen Combo Rapid Test Kit(Colloidal Gold) |
| Method |
Colloidal Gold |
| Specimen |
Nasal Swab |
| Detention Time |
15 mins |
| Storage Temperature |
4℃-30℃ |
| Shelf Life |
24 months |
| Package |
1 Test/ Box, 5 Tests/ Box, 25 Tests/ Box |
| Per Carton |
735 Tests/ CTN, 1000 Tests/ CTN, 1250 Tests/ CTN |
| Carton Dimension (cm) |
70cm * 45cm * 53cm |
| G.W/N.W(kg) |
19.5 / 17.5 |
The Contents of the Product:
| Cat.No |
Package |
Test Card |
Nasal Swab |
Extraction Reagent |
Tube Holder |
Waste bag |
IFU |
| P26001 |
1 Test/ Box |
1 |
1 |
1 |
- |
1 |
1 |
| P26005 |
1 Tests/ Box |
5 |
5 |
5 |
- |
1 |
1 |
| P26025 |
25 Tests/ Box |
25 |
25 |
25 |
- |
1 |
1 |
Materials Not Supplied With the PocRoc® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold):
Clock, Timer, or Stopwatch
Hand soap and water or hand sanitizer for cleaning your hands
Test Process:
Interpretation of Results:
Positive: if both the quality control line C and the test line (T or/and T1 or/and T2) appear, SARS-CoV-2 N antigen (or/and Flu A or/and Flu B) have been detected and the results are positive.
If the test result of COVID-19 is positive:
• There is a (suspected) infection of COVID-19. Contact your doctor or local health authorities as soon as possible.
• Comply with local regulations, isolation and report according to local regulations.
• Perform PCR test for confirmation.
NOTE: Co-infection with Influenza A, B and/or SARS-CoV-2 is rare. If results are positive for more than one antigen, i.e., Flu A, B and/or COVID-19, you should re-test the
specimens or contact your doctor.
Negative: if there is only a quality control line C, the test lines are colorless, indicating that SARS-CoV-2 N antigen or Flu A or Flu B has not been detected and the results are negative.
If the test result of COVID-19 is negative, continue to comply with all applicable rules regarding contacts and protective measures. Even if the test is negative, there may be an infection. In case of doubt, repeat the test after 1-2 days, if symptoms persist, please seek medical attention and further testing if required.
Invalid: if the quality control line C is colorless, it will be invalid regardless of whether there is color line in the test lines(T or/and T1 or/and T2), and the test should be done again. If the test result is invalid, it may be caused by incorrect test operation. Please repeat the test with a new test card.
Warnings and Precautions:
1. Read the Instructions for Use completely before using the test kit. Follow the instructions carefully, safely, and appropriately use the kit components and prevent possible misuse Failure to do so may result in an inaccurate result.
2. The test kit is for single use only, do not reuse any components of the test kit.
3. The test kit should be done within the first 4 days of symptom onset when viral shedding is highest.
4. Do not eat, drink or smoke in the area where handling specimens or test kits.
5. This test kit is for in vitro use only, do NOT swallow the extraction solution.
6. Guard against moisture, do not open the aluminum foil bag until you are ready to test. Do not use it if the aluminum foil bag is damaged or the test device is damp.
7. Avoid getting the extraction solution into the eyes or skin. If accidentally touch the skin, eyes, or mucous membranes, please rinse with water immediately. Please consult a doctor without delay if you feel discomfort.
8. Keep out of reach of pets and children. And the children using the test should be supervised and helped by the adults.
9. Do not use this test kit beyond the expiration date printed on the outer package. Always check the expiry date before testing.
10. Do not touch the reaction area of the test card.
11. Do not touch the soft end of the swab, which is the absorbent tip.
12. Do not use the test kit if the pouch is damaged or not well sealed.
13. Do not dilute the specimen for testing, otherwise, you may get inaccurate results.
14. The test kit shall be stored in strict accordance with the conditions specified in this Instructions for Use. Do not freeze the test kit.
15. Apply the drops of test specimen only to the specimen well(S) on the test card.
16. Too many or too few drops of test specimen may result in invalid or incorrect test results.
17. The specimen collection procedures may be uncomfortable. Do not insert the swab too much deeper, please stop the test if you feel strong resistance or pain.
18. Wear appropriate personal protective equipment and gloves when performing the test, collecting and handling specimens for another individual who need.
CERTIFICATE
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PocRoc® Helicobacter Pylori Antigen Rapid Test Kit (Colloidal Gold)
Helicobacter pylori Antigen Rapid Test Kit (Colloidal Gold) is a rapid lateral flow immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single test cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
