PANBIO™ COVID-19 Ag RAPID TEST DEVICE (NASAL)

Panbio™ COVID-19 Ag Rapid Test Device Asymptomatic & Self Swab Clinical Data Review

Panbio™ COVID-19 Ag Rapid Test Device 41FK11/41FK21

In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2 antigen (Ag)

About the Test

Introduction

The Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 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 cough. The main IVD assays used for COVID-19 employ real-time reverse transcriptase-polymerase chain reaction (RT-PCR) that takes a few hours. The availability of a cost-effective, rapid pointof-care diagnostic test is critical to enable healthcare professionals to aid in the diagnosis of patients and prevent further spread of the virus. Antigen tests will play a critical role in the fight against COVID-19.

Test Principle

Panbio™ COVID-19 Ag Rapid Test Device contains a membrane strip, which is pre-coated with 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 are visible in the result window prior to applying the patient specimen. A visible control line is required to indicate a test result is valid.

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 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 regulations. 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.

✅ Verifynds Checked

Payment Policy:

Cash on Delivery Available - for orders less than ₱2000 within Metro Manila

Cash on Delivery (no limit) available for Frontliners within Metro Manila (verification needed through Viber)

Cash on Pick-up available (no limit) for Frontliners (verification needed through Viber) and for orders less than ₱2000

For other orders, Verifynds will contact you regarding additional shipping payment for a combined fee (products + shipping) to be settled through Paymaya or GCASH

Shipping Policy:

No shipping charges for Pick-up. Current Pick up locations:

1. Asian Hospital and Medical Center (Fridays 12 noon)
2. Medical Center Manila (Saturdays 2 pm)
3. Qualimed Sta. Rosa, Laguna (Tuesdays 1 pm)
4. C&R Building, Manila (Monday to Friday 11 am - 3 pm)

₱200 additional shipping fee for orders within Metro Manila (standard 3-5 days delivery, bulk orders 7-10 days delivery, some items can be marked with special delivery times)

Domestic shipping (for areas outside of Metro Manila): Depending on local courier fees and options

International shipping (for areas outside of Metro Manila): Depending on local courier fees and options