SCALE-UP COVID-19 ANTIBODY TESTING
An in vitro diagnostic rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous, and fingerstick whole blood.
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 will not preclude SARS-CoV-2 infection, and they cannot be used as the sole basis for treatment or other management decisions. The test is not intended to be used as a donor screening test for SARS-CoV-2.
- Antibody tests are important to confirm that an infection has occurred.
- Quickly scale up COVID-19 coronavirus testing.
- Make testing more widely available.
- Decentralized testing can help to alleviate overcrowding in hospitals.
- Time to result: 10 – 20 minutes.
- Simple fingerstick blood sample.
The Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1 The SARS-CoV-2 is a β-coronavirus, which is an enveloped non-segmented positive-sense RNA virus.
It is spread by human-to-human transmission via droplets or direct contact and infection has been estimated to have a mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough3 The main IVD assays used for COVID-19 employ real-time reverse transcriptase-polymerase chain reaction (RT-PCR) that takes a few hours4 The availability of a cost-effective, rapid point-of-care diagnostic test is critical to enable healthcare professionals to aid in the diagnosis of patients and prevent further spread of the virus5 Antigen tests will play a critical role in the fight against COVID-196
Panbio COVID antigen kits contain a membrane strip, which is pre-coated with the immobilized anti-SARS-CoV-2 antibody on the test line and mouse monoclonal anti-chicken IgY on the control line.
Two types of conjugates (human IgG specific to SARS-CoV-2 Ag gold conjugate (binds to the nucleocapsid protein) and chicken IgY gold conjugate) move upward on the membrane chromatographically and react with anti-SARS-CoV-2 antibody and pre-coated mouse monoclonal anti-chicken IgY respectively.
For a positive result, human IgG specific to SARS-CoV-2 Ag gold conjugate and anti-SARS-CoV-2 antibody will form a test line in the result window. Neither the test line nor the control line is visible in the result window prior to applying the patient specimen. A visible control line is required to indicate a test result is valid.
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 nasal 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 SARSCoV-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.