Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a β coronavirus, which is a unsegmented positive sense RNA virus. It is transmitted from person to person transmission through 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 a cough. The main IVD tests used to COVID-19 uses real-time reverse transcriptase-polymerase chain reaction (RT-PCR) which takes a few hours. The availability of a rapid and cost-effective diagnostic test at the point of care is critical to enable healthcare professionals to assist in diagnosing patients and preventing the further spread of the virus. Antigen tests will play a key role in the fight against COVID-196.
The Pan ™ COVID-19 Ag Rapid Test Device contains 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 in the control line. Two types of conjugates (Human IgG specific for SARS-CoV-2 Ag gold conjugate (binds to nucleocapsid protein) and chicken IgY gold conjugate) move up 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 for SARS-CoV-2 Ag gold conjugate and anti-SARS-CoV-2 antibody. Form a test line in the results window. Neither the test line nor the control line is visible in the results window before applying the patient sample. A visible control line is required to indicate that a test result is valid.
The Pan ™ COVID-19 Ag Rapid Test Device is a rapid in vitro diagnostic test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasal swabs. Samples of individuals complying with clinical and/or epidemiological COVID-19. Criteria The 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 can 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 do not exclude SARSCoV-2 infection and cannot be used as the sole basis for treatment or other management decisions. Negative results should be combined with
observations, patient history, and epidemiological information. The proof is not intended to be used as a donor screening test for SARS-CoV-2.
- 41FK11 No 2D barcode printed on contained test devices
- 41FK21 Contains test devices with a 2D barcode printed on the test device, that encodes the traceability information of the product
• 25 desiccant test devices in a single foil pouch
• Buffer (1 x 9 ml / bottle)
• 25 extraction tubes
• 25 caps for extraction tubes
• 1 positive control swab
• 1 negative control swab
• 25 sterile nasal swabs for sample collection
• 1 rack for pipes
• 1 quick reference guide
• 1 Instructions for use
Materials required but not provided
Personal protective equipment according to local recommendations (ie gown/lab coat, mask, face shield/goggles and gloves), timer, biohazard container
Active ingredients of the main components
- 1 Test Device, Gold Conjugate: SARS-CoV-2 Ag Gold Specific Human IgG colloid and chicken IgY – gold colloid, test line: monoclonal mouse anti-SARS-CoV-2, control line: monoclonal mouse anti-chicken IgY
- Tricine buffer, sodium chloride, Tween 20, sodium azide (<0.1%), Proclin 300
Storage and stability
1. The test kit should be stored between 2 and 30 ° C. No freeze the kit or its components.
Note: When stored in a refrigerator, all components of the kit must be carried at room temperature (15-30 ° C) for a minimum of 30 minutes before performing the test. Do not open the bag while the components enter the room.
2. The buffer bottle can be opened and resealed for each assay. Buffer cap must be tightly sealed between each use. The buffer is stable until the expiration date if kept at 2-30 ° C.
3. Perform the test immediately after removing the tester from the slide bag.
4. Do not use the test kit after its expiration date.
5. The shelf life of the kit is as indicated on the outer package.
6. Do not use the test kit if the bag is damaged or the seal is broken.
7. Direct swab specimens should be tested immediately after collection. Yes, immediate testing is not possible, the swab sample can be stored in an extraction tube filled with extraction buffer (300 μl) at room temperature (15-30 ° C) up to two hours before the test.
- For in vitro diagnostic use only. Do not reuse the test device and kit components.
- These instructions must be strictly followed by a trained physician professional to achieve accurate results. All users must read the instructions before running a test.
- Do not eat or smoke while handling the samples.
- Wear protective gloves when handling samples and wash your hands thoroughly after.
- Avoid splashing or aerosol formation on the sample and buffer.
- Clean spills thoroughly with a suitable disinfectant.
- Decontaminate and discard all samples, reaction kits, and potentially contaminated materials (i.e. swab, collection tube, test device) in a biohazard container as infectious waste and dispose of in accordance with
- Do not mix or interchange different samples.
- Do not mix reagents from different lots or from other products.
- Do not store the test kit in direct sunlight.
- To avoid contamination, do not touch the head of the swab provided when opening the swab bag.
- Sterile swabs are to be used only for the collection of nasal samples.
- To avoid cross-contamination, do not reuse sterile sample swabs collection.
- Do not dilute the collected swab with any solution except the one provided extraction buffer.
- The buffer contains <0.1% sodium azide as a preservative that can be toxic if ingested. When discarding through a sink, rinse with a large amount of water.
- Do not use the positive or negative control swab for specimen collection.