Covid-19 Rapid Test Kit

Intended Use

Panbio COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. Panbio COVID-19 Ag Rapid Test Device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a donor screening test for SARS-CoV-2.

Materials Provided

• 1 Test devices with desiccant in individual foil pouch.
• 1 Extraction tubes with Cap and Solution.
• 1 Sterilized nasopharyngeal swabs for sample collection.

Warning

1. For vitro diagnostic use only. Do not reuse the test device and kit components.
2. Do not eat or smoke while handling specimens.
3. Wear protective gloves while handling specimens and wash hands thoroughly afterwards

Use of Covid-19 Rapid Test Device