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)1. The SARS-CoV-2 is a β-coronavirus, which is an enveloped non-segmented positive-sense RNA virus2. 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 (RTPCR) 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 fght against COVID-196.
Test Principle
Panbio™ COVID-19 Ag Rapid Test Device contains a membrane strip, which is pre-coated with immobilized anti-SARS-CoV-2 antibody onthe test line and mouse monoclonal anti-chicken IgY on the control line. Two types of conjugates (human IgG specifc to SARS-CoV-2 Ag gold conjugate and chicken IgY gold conjugate) move upward on the membrane chromatographically and react with anti-SARSCoV-2 antibody and pre-coated mouse monoclonal anti-chicken IgY respectively. For a positive result, human IgG specifc 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 rapidtest for the qualitative detection of SARS-CoV-2 antigen (Ag) in humannasopharyngeal swab specimens from individuals who meet COVID-19clinical and / or epidemiological criteria. Panbio™ COVID-19 Ag RapidTest Device is for professional use only and is intended to be used asan aid in the diagnosis of SARS-CoV-2 infection. The product may beused in any laboratory and non-laboratory environment that meets therequirements specifed in the Instructions for Use and local regulation.The test provides preliminary test results. Negative results don’t precludeSARS-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
- 25 Test devices with desiccant in individual foil pouch
- Buffer (1 x 9 ml/bottle)
- 25 Extraction tubes
- 25 Extraction tube caps
- 1 Positive control swab
- 1 Negative control swab
- 25 Sterilized nasopharyngeal swabs for sample collection
- 1 Tube rack
- 1 Quick reference guide (Nasopharyngeal)
- 1 Instructions for use
Materia ls Required but not Provided
- Personal Protective Equipment, Timer, Biohazard container
Active Ingredients of Main Components
- 1 Test deviceGold conjugate: Human IgG specifc to SARS-CoV-2 Ag gold colloid and Chicken IgY – gold colloid, Test line: Mouse monoclonal anti-SARS-CoV-2, Control line: Mouse monoclonal anti-Chicken IgY
- BufferTricine, Sodium Chloride, Tween 20, Sodium Azide (<0.1%),Proclin 300
Storage and Stability
- The test kit should be stored at a temperature between 2-30 °C. Do not freeze the kit or its components. Note: When stored in a refrigerator, all kit components must be brought to room temperature (15-30 °C) for a minimum of 30 minutes prior to performing the test. Do not open the pouch while components come to room temperature.
- The Buffer bottle may be opened and resealed for each assay. The Buffer cap should be frmly sealed between each use. The Buffer is stable until expiration date if kept at 2-30 °C.
- Perform the test immediately after removing the test device from the foil pouch.
- Do not use the test kit beyond its expiration date.
- The shelf life of the kit is as indicated on the outer package.
- Do not use the test kit if the pouch is damaged or the seal is broken.
- Direct swab specimens should be tested immediately after collection. If immediate testing is not possible, the swab specimen can be kept in an extraction tube flled with extraction buffer (300 μl) at room temperature (15-30 °C) for up to two hours prior to testing.
Warnings
- For in vitro diagnostic use only. Do not reuse the test device and kit components.
- These instructions must be strictly followed by a trained healthcare professional to achieve accurate results. All users have to read the instruction prior to performing a test.
- Do not eat or smoke while handling specimens.
- Wear protective gloves while handling specimens and wash hands thoroughly afterwards.
- Avoid splashing or aerosol formation of specimen and buffer.
- Clean up spills thoroughly using an appropriate disinfectant.
- Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials (i.e. swab, extraction tube,test device) in a biohazard container as if they were infectious waste and dispose according to applicable local regulations.
- Do not mix or interchange different specimens.
- Do not mix reagent of different lots or those for other products.
- Do not store the test kit in direct sunlight.
- To avoid contamination, do not touch the head of provided swab when opening the swab pouch.
- The provided sterilized swabs in the package should be used only for nasopharyngeal specimen collection.
- To avoid cross-contamination, do not reuse the sterilized swabsfor specimen collection.
- Do not dilute the collected swab with any solution except for the provided extraction buffer.
- The buffer contains <0.1% sodium azide as a preservative which may be toxic if ingested. When disposed of through a sink, flush with a large volume of water.7
Test Procedure (Refer to Figure)
Nasopharyngeal Swab SpecimensNote: Healthcare professionals should comply with personal safetyguidelines including the use of personal protective equipment.
Test Preparation
- Allow all kit components to reach a temperature between 15-30 °C prior to testing for 30 minutes.
- Remove the test device from the foil pouch prior to use. Place on a flat, horizontal and clean surface.
- Hold the buffer bottle vertically and fll the extraction tube withbuffer fluid until it flows up to the Fill-line of the extraction tube (300 μl).
Caution: If the amount of buffer is excessive or insufcient,an improper test result may occur.
- Place the extraction tube in the tube rack.
Specimen Collection & Extraction
- Tilt the patient’s head back slightly about 45°-70° to straighten the passage from the front of the nose.
- Insert the swab with a flexible shaft through the nostril parallel to the palate.
Caution: Use dedicated nasopharyngeal swab for specimen collection.
- Swab should reach depth equal to distance from nostrils to outer opening of the ear.
Caution: If resistance is encountered during insertion of the swab, remove it and attempt insertion in the opposite nostril.
- Gently rub and roll the swab, 3-4 times. Leave the swab in place for several seconds to absorb secretions.
- Slowly remove swab while rotating it and insert into the extraction tube.
- Swirl the swab tip in the buffer fluid inside the extraction tube, pushing into the wall of the extraction tube at least fve times and then squeeze out the swab by squeezing the extraction tube with your fngers.
- Break the swab at the breakpoint and close the cap of extraction tube.
Reaction with Test Device
- Open the dropping nozzle cap at the bottom of the extraction tube.
- Dispense 5 drops of extracted specimens vertically into the specimen well (S) on the device. Do not handle or move the test device until the test is complete and ready for reading.
Caution: Bubbles that occur in the extraction tube can lead to inaccurate results. If you are unable to create sufcient drops,this may be caused by clogging in the dispensing nozzle. Shakethe tube gently to release the blockage until you observe freedrop formation.
- Close the nozzle and dispose of the extraction tube containing the used swab according to your local regulations and biohazard waste disposal protocol.
- Start timer. Read result at 15 minutes. Do not read results after 20 minutes.
- Dispose of the used device according to your local regulationsand biohazard waste disposal protocol.
Positive / Negative Control Swab
- Hold the buffer bottle vertically and fll the extraction tube with buffer fluid until it flows up to the Fill-line of the extraction tube (300 μl).
Caution: If the amount of buffer is excessive or insufcient,an improper test result may occur.
- Place the extraction tube in the tube rack.
- Insert the positive or negative control swab in the buffer fluid inside of the extraction tube and soak the swab for 1 minute. Swirl the control swab tip in the buffer fluid inside of theextraction tube, pushing into the wall of the extraction tube at least fve times and then squeeze out the swab by squeezing the extraction tube with your fngers.
- Dispose of the used control swab in accordance with your biohazard waste disposal protocol.
- Close the cap of the extraction tube.
- Follow the above test procedure [Reaction with Test Device].
Test Interpretation (Refer to Figure)
- Negative result: The presence of only the control line (C) and no test line (T) within the result window indicates a negative result.
- Positive result: The presence of the test line (T) and the control line (C) within the result window, regardless of which line appears frst, indicates a positive result.
Caution: The presence of any test line (T), no matter how faint, indicates a positive result.
- Invalid result: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
Test Limitations
- The contents of this kit are to be used for the professional and qualitative detection of SARS-CoV-2 antigen from nasopharyngeal swab. Other specimen types may lead to incorrect results and must not be used.
- Failure to follow the instructions for test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results.
- A negative test result may occur if the specimen was collected, extracted or transported improperly. A negative test result does not eliminate the possibility of SARS-CoV-2 infection and should be confrmed by viral culture or a molecular assay or ELISA.
- Positive test results do not rule out co-infections with other pathogens.
- For further information on immune status, additional follow-up testing using other laboratory methods is recommended.
- Test results must be evaluated in conjunction with other clinical data available to the physician.
- Reading the test results earlier than 15 minutes or later than 20 minutes may give incorrect results.
- Panbio™ COVID-19 Ag Rapid Test Device is not intended to detect from defective (non-infectious) virus during the later stages of viral shedding that might be detected by PCR molecular tests.8
Quality Control
- Internal Quality Control: The test device has a test line (T) and a control line (C) on the surface of the test device. Neither the test line nor the control line are visible in the result window before applying a specimen. The control line is used for procedural control and should always appear if the test procedure is performed properly and the test reagents of the control line are working.
- External Quality Control: The controls are specifcally formulated and manufactured to ensure performance of the Panbio™ COVID-19 Ag Rapid Test Device and are used to verify the user’s ability to properly perform the test and interpret the results. The Positive Control will produce a positive test result and has been manufactured to produce a visible test line (T). The Negative Control will produce a negative test result. Good laboratory practice suggests the use of positive and negative controls to ensure that:• Test reagents are working, and• The test is correctly performed.Run the external controls under the following circumstances:• With each new operator prior to performing testing on patient specimens,• When receiving a new test shipment,• At periodic intervals as dictated by local, state and country requirements, and/or by the user’s Quality Control procedures.
Performance Characteristics
- External evaluation of Panbio™ COVID-19 Ag Rapid Test Device Clinical performance of Panbio™ COVID-19 Ag Rapid Test Device was determined by testing 60 positive and 181 negative specimens for SARSCoV-2 antigen (Ag) to have a sensitivity of 93.3% (95% CI: 83.8-98.2%) and specifcity of 99.4% (95% CI: 97.0-100%). Clinical specimens were determined to be positive or negative using an FDA EUA RT-PCR reference method.Panbio™ COVID-19 Ag Rapid Test Device Results
• Performance data was calculated from a study of individuals suspected of exposure to COVID-19 or who have presented with symptoms in the last 7 days.• Stratifcation of the positive specimens post onset of symptoms or suspected exposure between 0-3 days has a sensitivity of 100.0% (n=21) and 4-7 days has a sensitivity of 89.7% (n=39).• Positive agreement of the Panbio™ COVID-19 Ag Rapid Test Device is higher with samples of Ct values ≤33 with a sensitivity of 98.2%. As suggested in References 8 and 9, patients with Ct value >33 are no longer contagious.8, 9
- Detection LimitPanbio™ COVID-19 Ag Rapid Test Device was confrmed to detect 2.5X101.8 TCID50/ml of SARS-CoV-2 which was isolated from a COVID-19 confrmed patient in Korea.
- Hook EffectThere is no hook effect at 1.0×105.8 TCID 50/ml of SARS- CoV-2 which was isolated from a COVID-19 confrmed patient in Korea.
- Cross ReactivityCross-reactivity of Panbio™ COVID-19 Ag Rapid Test Device was evaluated by testing 20 viruses and 12 other microorganisms. The fnal test concentrations of viruses and other microorganisms are documented in the Table below. The following viruses and other microorganisms have no effect on the test results of Panbio™ COVID-19 Ag Rapid Test Device.
- Interfering SubstancesThe following 28 potentially interfering substances have no impact on Panbio™ COVID-19 Ag Rapid Test Device. The fnal test concentrations of the interfering substances are documented in the Table below.
- Repeatability & ReproducibilityRepeatability & Reproducibility of Panbio™ COVID-19 Ag Rapid Test Device was established using in-house reference panels containing negative specimens and a range of positive specimens. There were no differences observed within-run, between-run, between-lots, between-sites, and between-days.
PREPARATION
- Allow all kit components to reach a temperature between 15-30°C prior to testing for 30 minutes.Note: Healthcare professionals should comply with personal safety guidelines including the use of personal protective equipment.
- Open the package and look for the following:1.Test device with desiccant in individual foil pouch2. Buffer3. Extraction tube4. Extraction tube cap5. Positive control swab6. Negative control swab7. Sterilized nasopharyngeal swabs for sample collection8. Tube rack9. Quick reference guide (Nasopharyngeal)10. Instructions for use
- Carefully read these instructions prior to using Panbio™ COVID-19 Ag Rapid Test Device kit.
- Carefully read these instructions prior to using Panbio™ COVID-19 Ag Rapid Test Device kit.
- Open the foil pouch and look for the following:1. Result window2. Specimen wellThen, label the device with the patient identifier
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