PCL’s COVID-19 Antigen test is very easy to use and requires no specialised knowledge. The test is comfortably done within 10 minutes requiring only a little saliva, dispensing with the sometimes unpleasant and even painful nasopharyngeal swabs. This makes the test ideal for quick detection of risk potential in sensitive areas of clinics, care facilities, test centers, companies, industries, and practices.
2 Tests in Box:
- 2 test cards
- 2 extraction buffer tubes
- 2 filter caps
- 2 funnel applicators
How accurate is the test?
The product has been developed in elaborate methods and has been approved by the competent authorities. The proven test results are excellent:
The clinical sensitivity is 91 %, and the clinical specificity is 99 %.
Intended Use
PCL SELF TEST-COVID19 Ag is a rapid Immunochromatographic assay (ICA)for the qualitative detection of SARS-CoV-2nucleocapsidanti-gens from saliva that is self-collected by an individual aged 14 years or older or is collected by an adult from an individual 2 years of age and older. This test is intended for use in individuals with symptoms of COVID-19 within the first 7 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Persons who test positive with the PCL SELF TEST-COVID19 Ag should seek to follow-up care with their physician or healthcare providers additional testing and public health reporting may be necessary. Positive results do not rule out bacterial infection or coinfection with other viruses. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough, and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow-up care with their physician or healthcare provider. The PCL SELF TEST-COVID19 Ag is intended for home use and, as applicable for a lay user testing another person, including self-testing in a non-laboratory setting. The PCL SELF TEST-COVID19 Ag is only for use under the Interim Order No.3 Respecting the Importation and Sale of Medical Devices for Use in Relations to COVID-19.
