COVID-19 Saliva Rapid Test Kit
SKU: PDSTKA-U
Overview
Our Panodyne Antigen Saliva Test Kit is a user-friendly and non-invasive rapid test kit that can be self-administered under supervision by trained staff, healthcare professional, company nurse or occupational health personnel. It's also more comfortable and easier to use for vulnerable people or those with a disability.
COVID-19 Saliva Rapid Test Kit Benefits
- Painless sampling
- Mouth lollipop
- Reduce pollution
- Safe
- Results can be seen in 15 minutes
- Accuracy above 95%
Kit contents
- Test cassette
- Biohazard waste bag
- Instruction manual
Organisations and businesses who already are or wish to implement a test tracking program, please click on the link below to download the Panodyne COVID-19 Saliva test declaration form for subjects to sign and for your records. The declaration form can be used for research and consent form purposes only.
- Product Name: Panodyne SARS-CoV-2 Nucleocapsid (N) Antigen Saliva Rapid Test Kit (Colloidal Gold)
- Pack Formats: 1 Test
- Test Type: Antigen Test
- Test Principle: Colloidal Gold Method
- Sample Type: Saliva
- Test Time: 15 Mins
- Storage Temperature: Room Temperature or Refrigerated (4-30°C)
- Shelf Life (Unopened): 24 Months
- Remove the orange cover of the test card.
- Put the absorbent tip of the test card into the mouth with the absorbent tip pressed under the tongue. Take out the test card after 2 minutes.
- Place the test card horizontally, check start time and read the displayed result within 10-15 minutes. After 15 minutes the results are invalid.
- For single use only, dispose of the test card responsibly after use.
Performance characteristics
Antigen Saliva Test Cassette Results | PCR: Positive | PCR: Negative | Total Results |
Antigen Test Cassette Positive | 148 | 2 | 150 |
Antigen Test Cassette Negative | 2 | 248 | 250 |
Total Results | 150 | 250 | 400 |
Sensitivity and Specificity: the COVID-19 Antigen Saliva Test Cassette was compared with a commercial PCR and the results show a high sensitivity and specificity.
Relative Sensitivity: 98.67% (95%CI: 92.94-99.43%)
Relative Specificity: 99.20% (95%CI: 96.32-99.87%)
Accuracy: 99% (95%CI: 97.77-99.92%)
- This test detects both viable (live) and non-viable, SARS-CoV and COVID-19. Test performance depends on the amount of virus (antigen) in the sample and may or may not be correlated with viral culture results performed on the same sample.
- A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
- The performance of COVID-19 Antigen Test Cassette was evaluated using the procedures provided in this product insert only. Modifications to these procedures may alter the performance of the test.
- False negative results may occur if a specimen is improperly collected, transported, or handled.
- If the test is performed more than 1 hour after the specimen is collected, false results may occur. The specimen should be tested as soon as possible after specimen collection.
- Positive test results do not rule out co-infections with other pathogens.
- Positive test results do not differentiate between SARS-CoV and COVID-19.
- Negative test results are not intended to rule out other non-SARS viral or bacterial infections.
- Negative results from patients with symptom onset beyond seven days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed.
- If the differentiation of specific COVID-19 viruses and strains was needed, additional testing, in consultation with state or local public health departments is required.
Since its establishment in August 2020, the joint UK Health Security Agency (UKHSA) Porton Down and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell has evaluated over 160 lateral flow devices that have been referred by the Department of Health and Social Care.
Read further information about Panodyne COVID-19 ANTIGEN RAPID TEST KIT passing phase 3 validation:
