Abbott Panbio Covid-19 Ag Rapid Test Device Instruction Manual

Abbott Panbio COVID-19 Ag Rapid Test Device

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 (RT-PCR) that takes a few hours4. The availability of a cost-effective, rapid pointofcare 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.

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 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.

Kit Variants
• 41FK11 No 2D barcode printed on the contained test devices
• 41FK21 Contains test devices with a 2D barcode printed on the test device,
which encodes traceability information for the product
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 nasal swabs for sample collection
• 1 Tube rack
• 1 Quick Reference Guide
• 1 Instructions for use

Materials Required but not Provided

• Personal Protective Equipment per local recommendations (i.e. gown/ lab coat, face mask, face shield/eye goggles and gloves), Timer, Biohazard container
  Active Ingredients of Main Components
• 1 Test device Gold conjugate: Human IgG specific 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
• Buffer Tricine, Sodium Chloride, Tween 20, Sodium Azide (<0.1%), Proclin 300

Storage and Stability

1. 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.
2. The Buffer bottle may be opened and resealed for each assay. The Buffer cap should be firmly sealed between each use. The Buffer is stable until expiration date if kept at 2-30 °C.
3. Perform the test immediately after removing the test device from the foil pouch.
4. Do not use the test kit beyond 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 pouch is damaged or the seal is broken.
7. 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 filled with extraction buffer (300 μl) at room temperature (15-30 °C) for up to two hours prior to testing.

Warnings

1. For in vitro diagnostic use only. Do not reuse the test device and kit components.
2. 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.
3. Do not eat or smoke while handling specimens.
4. Wear protective gloves while handling specimens and wash hands thoroughly afterwards.
5. Avoid splashing or aerosol formation of specimen and buffer.
6. Clean up spills thoroughly using an appropriate disinfectant.
7. 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.
8. Do not mix or interchange different specimens.
9. Do not mix reagent of different lots or those for other products.
10. Do not store the test kit in direct sunlight.
11. To avoid contamination, do not touch the head of provided swab when opening the swab pouch.
12. The sterilized swabs should be used only for nasal specimen collection.
13. To avoid cross-contamination, do not reuse the sterilized swabs for specimen collection.
14. Do not dilute the collected swab with any solution except for the provided extraction buffer.
15. 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
16. Do not use the positive or negative control swab for specimen collection.

Test Procedure (Refer to Figure)
Nasal swab Specimens

Note: Healthcare professionals should comply with personal safety guidelines including the use of personal protective equipment.

Test Preparation

1. Allow all kit components to reach a temperature between 15-30 °C prior to testing for 30 minutes.
2. Remove the test device from the foil pouch prior to use. Place on a flat, horizontal and clean surface.
3. Hold the buffer bottle vertically and fill 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 insufficient, an improper test result may occur.
4. Place the extraction tube in the tube rack.

Nasal Mid-Turbinate (NMT) Specimen Collection & Extraction

1. Tilt the patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril (until resistance is met atthe turbinates).
2. Rotate the swab five times against the nasal wall then slowly remove from  the nostril.
3. Using the same swab repeat the collection procedure with the second nostril.
   Caution: If the swab stick breaks during specimen collection, repeat specimen collection with a new swab.
4. Swirl the swab tip in the buffer fluid inside the extraction tube, pushing into the wall of the extraction tube at least five times and then squeeze out the swab by squeezing the extraction tube with your fingers.
5. Break the swab at the breakpoint and close the cap of extraction tube.

Reaction with Test Device

1. Open the dropping nozzle cap at the bottom of the extraction tube.
2. 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 sufficient drops, this may be caused by clogging in the dispensing nozzle. Shake the tube gently to release the blockage until you observe free drop formation.
3. Close the nozzle and dispose of the extraction tube containing the used swab according to your local regulations and biohazard waste disposal protocol.
4. Start timer. Read result at 15 minutes. Do not read results after 20 minutes.
5. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.

Positive / Negative Control Swab
Caution: Control use only. Do not use the positive or negative control swab for specimen collection.

Note: Please refer to the External Quality Control section of this Instructions for use for the frequency of testing external quality control swabs.

1. Hold the buffer bottle vertically and fill 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 insufficient, an improper test result may occur.
2. Place the extraction tube in the tube rack.
3. 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 the extraction tube, pushing into the wall of the extraction tube at least five times and then squeeze out the swab by squeezing the extraction tube with your fingers.
4. Dispose of the used control swab in accordance with your biohazard waste disposal protocol.
5. Close the cap of the extraction tube.
6. Follow the above test procedure [Reaction with Test Device].

Test Interpretation (Refer to Figure)

1. Negative result: The presence of only the control line (C) and no test line (T) within the result window indicates a negative result.
2. Positive result: The presence of the test line (T) and the control line (C) within the result window, regardless of which line appears first, indicates a positive result.
   Caution: The presence of any test line (T), no matter how faint, indicates a positive result.
3. 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

1. The contents of this kit are to be used for the professional and qualitative detection of SARS-CoV-2 antigen from nasal swab. Other specimen types may lead to incorrect results and must not be used.
2. Failure to follow the instructions for test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results.
3. 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 confirmed by viral culture or a molecular assay.
4. Positive test results do not rule out co-infections with other pathogens.
5. Test results must be evaluated in conjunction with other clinical data available to the physician.
6. Reading the test results earlier than 15 minutes or later than 20 minutes may give incorrect results.
7. 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
8. Positive results may occur in cases of infection with SARS-CoV.

Quality Control

1. 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.
2. External Quality Control:
   The controls are specifically 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 contains recombinant SARS-CoV-2 nucleocapsid protein, which is not contagious. 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. Control swabs are not specific for a particular Panbio™ COVID-19 Ag Rapid Test Device lot and may be used between test device lots until the swabs’ expiry dates.
   Good laboratory practice suggests the use of positive and negative controls to ensure that:
   • Test reagents are working, and
   • The test is correctly performed.
     The external controls can be run under any of the following circumstances:
   • By a new operator prior to performing testing on patient specimens,
   • When receiving a new test shipment,
   • At periodic intervals as dictated by local requirements, and/or by the user’s Quality Control procedures.

Performance Characteristics

1. External evaluation of Panbio™ COVID-19 Ag Rapid Test Device (Symptomatic) Clinical performance of Panbio™ COVID-19 Ag Rapid Test Device was determined by testing 104 positive nasal swab specimens and 404 negative specimens for SARS-CoV-2 antigen (Ag) to have a sensitivity of 98.1% (95%
   CI: 93.2-99.8%) and a specificity of 99.8% (95% CI: 98.6-100.0%). Clinical specimens were determined to be positive or negative using an FDA EUA RT-PCR reference method. The individuals on which the reported sensitivity and specificity are based also had a nasopharyngeal swab taken, which was tested in the FDA EUA-approved RT-PCR.
   Panbio™ COVID-19 Ag Rapid Test Device Results

   		Nasal PCR Test Result
   		Positive	Negative	Total
   Panbio™ COVID-19	Positive	102	1	103
   Ag Rapid Test Device	Negative	2	403	405
   Result (nasal swab	Total	104	404	508
   specimens)
   		Sensitivity	Specificity	Overall Percent
   				Agreement
   		98.1%	99.8%	99.4%
   		[93.2%; 99.8%]	[98.6%; 100.0%]	[98.3%; 99.9%]

   • 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.
   • Stratification of the positive specimens post onset of symptoms or suspected exposure between 0-3 days has a sensitivity of 100.0% (95% CI: 92.3- 100.0%; n=46) and 4-7 days has a sensitivity of 96.6% (95% CI: 88.1- 99.6%; n=58).
   • Positive agreement of the Panbio™ COVID-19 Ag Rapid Test Device is higher with samples of Ct values ≤30 with a sensitivity of 100.0% (95% CI: 96.0-100.0%) and Ct values ≤33 with a sensitivity of 99.0% (95% CI: 94.5- 100.0%). As indicated in References 8-10, patients with Ct value >30 are no longer contagious. 8, 9, 10
   • The clinical performance data was also calculated vs nasopharyngeal swab specimens using an FDA EUA RT-PCR reference and has a sensitivity of 91.1% (95% CI: 84.2-95.6%) and specificity of 99.7% (95% CI: 98.6- 100.0%).
2. External evaluation of Panbio™ COVID-19 Ag Rapid Test Device (Asymptomatic) Clinical performance of Panbio™ COVID-19 Ag Rapid Test Device was determined by testing 483 asymptomatic subjects for SARS-CoV-2 antigen (Ag). Clinical specimens were determined to be positive or negative using an FDA EUA RT-PCR reference method.
   The positive results (n=50) were stratified by the comparator method cycle threshold (Ct) counts and assessed to better understand the correlation of product performance, as a surrogate for the amount of virus present in the clinical sample. A lower Ct value corresponds to a higher virus concentration.
   As presented in the table below, the positive agreement increases with lower Ct values.
   The specificity (n=433) was 100% with 95% CI [99.2%; 100.0%].
   The results for sensitivity are summarized in the following table:

   	All Nasal PCR Positive Samples (n=50)	Ct values ≤ 33 (n=40)	Ct values ≤ 30 Ct (n=32)
   Sensitivity	66.0%	80.0%	93.8%
   [CI 95%]	[51.2%; 78.8%]	[64.4%; 90.9%]	[79.2%; 99.2%]

   As indicated in References 8-10, patients with Ct value >30 are no longer contagious. 8, 9, 10

3. External evaluation of Panbio™ COVID-19 Ag Rapid Test Device (Self-Collected Swab)
   The clinical performance of Panbio™ COVID-19 Ag Rapid Test Device was assessed in 287 symptomatic subjects (≥16 years of age) who collected their swab specimen (self swabbing) under the direction and supervision of a trained professional. The swab was then handed to the trained professional who executed the remaining steps of the procedure. The trained professional also collected a nasopharyngeal swab from each subject to be used as a reference specimen. The reference specimen was tested on the Panbio™ COVID-19
   Ag Rapid Test Device.
   The results are summarized in the following table:

   		Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)
   		Positive	Negative	Total
   Panbio™ COVID-19	Positive	110	0	110
   Ag Rapid Test Device	Negative	2	175	177
   (Nasal) – Self-collected	Total	112	175	287
   Swab
   		Positive	Negative	Overall Percent
   		Agreement	Agreement	Agreement
   		98.2%	100.0%	99.3%
   		[93.7%; 99.8%]	[97.9%; 100.0%]	[97.5%; 99.9%]

4. Detection Limit
   Panbio™ COVID-19 Ag Rapid Test Device was confirmed to detect 2.5X101.8 TCID50/ml of SARS-CoV-2 which was isolated from a COVID-19-confirmed patient in Korea.
5. Hook Effect
   There is no hook effect at 1.0×105.8 TCID50/ml of SARS-CoV-2 which was isolated from a COVID-19-confirmed patient in Korea.
6. Cross Reactivity
   Cross-reactivity of Panbio™ COVID-19 Ag Rapid Test Device was evaluated by testing 28 viruses and 13 other microorganisms. The final test concentrations of viruses and other microorganisms are documented in the Table below. The following viruses and other microorganisms except the Human SARS-coronavirus Nucleoprotein have no effect on the test results of Panbio™ COVID-19 Ag Rapid Test Device.
   Panbio™ COVID-19 Ag Rapid Test Device has cross-reactivity with Human- SARS-coronavirus Nucleoprotein at a concentration of 25 ng/ml or more because SARS-CoV has high homology (79.6%) to SARS-CoV-2.

   No.	Types of Specimen	Cross Reaction Substance	Final Test Concentration	Test Result
   1	Virus	Adenovirus Type 1	2.2 X 107 TCID50/ml	No cross reaction
   2		Adenovirus Type 5	5.71 X 108 TCID50/ml	No cross reaction
   3		Adenovirus Type 7	2.86 X 109 TCID50/ml	No cross reaction
   4		Enterovirus (EV68)	2.81 X 107 TCID50/ml	No cross reaction
   5		Echovirus2	1.0 X 106.5 TCID50/ml	No cross reaction
   6		Echovirus11	5.0 X106.25 TCID50/ml	No cross reaction
   7		Enterovirus D68	2.81 X 107 TCID50/ml	No cross reaction
   8		Human herpesvirus (HSV) 1	5.0 X 107.5 TCID50/ml	No cross reaction
   9		Human herpesvirus (HSV) 2	5.0 X 105.75 TCID50/ml	No cross reaction
   10		Mumps Virus Ag	1.58 X 105 TCID50/ml	No cross reaction
   11		Influenza virus A (H1N1) Strain (A/Virginia/ATCC1/2009)	3.71 X 105 PFU/ml	No cross reaction
   12		Influenza virus A (H1N1) Strain (A/WS/33)	5.0 X 107.25 TCID50/ml	No cross reaction
   13		Influenza virus A(H1N1) Strain (A/California/08/2009/pdm09)	1.6 X 108 TCID50/ml	No cross reaction
   14		Influenza virus B Strain (B/ Lee/40)	5.0 X 106.25 TCID50/ml	No cross reaction
   15		Parainfluenza Type 1	3.06 X 108 TCID50/ml	No cross reaction
   16		Parainfluenza Type 2	5.0 X 105 TCID50/ml	No cross reaction

   No.	Types of Specimen	Cross Reaction Substance	Final Test Concentration	Test Result
   17	Virus	Parainfluenza Type 3	6.6 X 107 TCID50/ml	No cross reaction
   18		Parainfluenza Type 4A	2.81 X 107 TCID50/ml	No cross reaction
   19		Respiratory syncytial virus (RSV) type A	4.22 X 105 TCID50/ml	No cross reaction
   20		Respiratory syncytial virus (RSV) type B	5.62 X 105 TCID50/ml	No cross reaction
   21		Rhinovirus A16	1.26 X 106 TCID50/ml	No cross reaction
   22		HCoV-HKU1	1.5mg/ml	No cross reaction
   23		HCoV-NL63	1.7 X 105 TCID50/ml	No cross reaction
   24		HCoV-OC43	8.9 X 105 TCID50/ml	No cross reaction
   25		HCoV-229E	1.51 X 106 TCID50/ml	No cross reaction
   26		Human SARS-coronavirus Nucleoprotein	25ng/ml	Cross reaction
   27		MERS-CoV Nucleoprotein	0.25mg/ml	No cross reaction
   28		Human Metapneumovirus (hMPV) 16 Type A1	1.51 X 106 TCID50/ml	No cross reaction

   No.	Types of Specimen	Cross Reaction Substance	Final Test Concentration	Test Result
   1	Other Microorganism	Staphylococcus saprophyticus	1.9 X 107 CFU/ ml	No cross reaction
   2		Neisseria sp.(Neisseria lactamica)	1.7 X 108 CFU/ ml	No cross reaction
   3		Staphylococcus haemolyticus	3.5 X 109 CFU/ ml	No cross reaction
   4		Streptococcus salivarius	1.96 X 107 CFU/ ml	No cross reaction
   5		Hemophilus parahaemolyticus	2.2 X 108 CFU/ ml	No cross reaction
   6		Proteus vulgaris	7.2 X 106 CFU/ ml	No cross reaction
   7		Moraxella catarrhalis	4.7 X 107 CFU/ ml	No cross reaction
   8		Klebsiella pneumoniae	5.0 X 106 CFU/ ml	No cross reaction
   9		Fusobacterium necrophorum	1.75 X 108 CFU/ ml	No cross reaction
   10		Mycobacterum tuberculosis	10mg/ml	No cross reaction
   11		Pooled human nasal wash	N/A*	No cross reaction
   12		Streptococcus pyogenes	3.6 X 107 CFU/ ml	No cross reaction
   13		Mycoplasma pneumoniae	4 X 108 CFU/ml	No cross reaction

   No concentration provided by supplier. Undiluted stock solution was tested.

7. Interfering Substances
   The following 43 potentially interfering substances have no impact on Panbio™ COVID-19 Ag Rapid Test Device. The final test concentrations of the interfering substances are documented in the Table below.

   No.	Types of Specimen	Interfering Substances	Final Test Concentration	Test Result
   1	Endogenous Substance	Mucin	0.5%	No Interference
   2		Hemoglobin	100 mg/L	No Interference
   3		Triglycerides	1.5 mg/L	No Interference
   4		Icteric (Bilirubin)	40 mg/dL	No Interference
   5		Rheumatoid factor	200 IU/ml	No Interference
   6		Anti-nuclear antibody	>1:40	No Interference
   7		Pregnant	10-fold dilution	No Interference
   8	Exogenous Substance	Guaiacol glyceryl ether	1 μg/ml	No Interference
   9		Albuterol	0.005 mg/dL	No Interference
   10		Ephedrine	0.1 mg/ml	No Interference
   11		Chlorpheniramine	0.08 mg/dL	No Interference
   12		Diphenhydramine	0.08 mg/dL	No Interference
   13		Ribavirin	26.7 μg /ml	No Interference
   14		Oseltamivir	0.04 mg/dL	No Interference
   15		Zanamivir	17.3 μg /ml	No Interference
   16		Phenylephrine hydrochloride	15% v/v	No Interference
   17		Oxymetazolin hydrochloride	15% v/v	No Interference
   18		Amoxicillin	5.4 mg/dL	No Interference
   19		Acetylsalicylic acid	3 mg/dL	No Interference
   20		Ibuprofen	21.9 mg/dL	No Interference
   21		Chlorothiazide	2.7 mg/dL	No Interference
   22		Indapamide	140 ng/ml	No Interference
   23		Glimepiride (Sulfonylureas)	0.164 mg/dL	No Interference
   24		Acarbose	0.03 mg/dL	No Interference
   25		Ivermectin	4.4 mg/L	No Interference
   26		Lopinavir	16.4 μg/L	No Interference
   27		Ritonavir	16.4 μg/L	No Interference
   28		Chloroquine phosphate	0.99 mg/L	No Interference

   No.	Types of Specimen	Interfering Substances	Final Test Concentration	Test Result
   29	Exogenous Substance	Sodium chloride with preservatives	4.44 mg/ml	No Interference
   30		Beclomethasone	4.79 ng/ml	No Interference
   31		Dexamethasone	0.6 µg/ml	No Interference
   32		Flunisolide	0.61 µg/ml	No Interference
   33		Triamcinolone	1.18 ng/ml	No Interference
   34		Budesonide	2.76 ng/ml	No Interference
   35		Mometasone	1.28 ng/ml	No Interference
   36		Fluticasone	2.31 ng/ml	No Interference
   37		Sulfur	9.23 µg/ml	No Interference
   38		Benzocaine	0.13 mg/ml	No Interference
   39		Menthol	0.15 mg/ml	No Interference
   40		Mupirocin	10 µg/ml	No Interference
   41		Tobramycin	24.03 µg/ml	No Interference
   42		Biotin	1.2 µg/ml	No Interference
   43		HAMA	63.0 ng/ml	No Interference

8. Repeatability & Reproducibility
   Repeatability & 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

1. 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.
2. Open the package and look for the following:
   1. Test device with desiccant in individual foil pouch
   2. Buffer
   3. Extraction tube
   4. Extraction tube cap
   5. Positive control swab
   6. Negative control swab
   7. Sterilized nasal swabs for sample collection
   8. Tube rack
   9. Quick reference guide
   10. Instructions for use
3. Carefully read these instructions prior to using Panbio™
   COVID-19 Ag Rapid Test Device kit.
4. Look at the expiration date of the kit box. If the expiration date has passed, use another kit.
5. Open the foil pouch and look for the following:
   1. Result window
   2. Specimen well
      Then, label the device with the patient identifier.

TEST PROCEDURE

1. Hold the buffer bottle vertically and fill the extraction tube with buffer fluid until it flows up to the Fill-line of the extraction tube (300μl).
   Caution: If the amount of buffer is excessive or insufficient, an improper test result may occur.
2. Place the extraction tube in the tube rack.
3. Tilt the patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril (until resistance is met at the turbinates). Rotate the swab five times against the nasal wall. Using the same swab repeat the collection procedure with the second nostril. Slowly remove swab from the nostril.
   Caution: If the swab stick breaks during specimen collection, repeat specimen collection with a new swab.
4. Insert the swab specimen in 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 five times and then squeeze out the swab by squeezing the extraction tube with your fingers.
5. Break the swab at the breakpoint and close the cap of extraction tube.
6. Open the dropping nozzle cap at the bottom of the extraction tube.
7. 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 sufficient drops, this may be caused by clogging in the dispensing nozzle. Shake the tube gently to release the blockage until you observe free drop formation.
8. Close the nozzle and dispose of the extraction tube containing the used swab according to your local regulations and biohazard waste disposal protocol.
9. Start timer. Read result at 15 minutes. Do not read results after 20 minutes.
10. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.

TEST INTERPRETATION

NEGATIVE

The presence of only the control line (C) and no test line (T) within the result window indicates a negative result.

POSITIVE

The presence of the test line (T) and the control line (C) within the result window, regardless of which line appears first, indicates a positive result.
Caution: The presence of any test line (T), no matter how faint, indicates a positive result.

INVALID

If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Instructions may not have been followed correctly. It is recommended to read the IFU again before re-testing the specimen with a new test device.

REFERENCES

1. Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020; Feb 26:102433. doi: 10.1016/j.jaut.2020.102433.
2. Guo YR, Cao QD, Hong ZS, et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak-an update on the status. Mil Med Res. 2020; Mar 13; 7(1):11.doi:10.1186/s40779-020-00240-0.
3. Lai CC, Shih TP, Ko WC, et al. Severe acute respiratory syndrome coronavirus 2 (SARSCov- 2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020; Mar 55(3): 105924.doi: 10.1016/j.ijantimicag.2020.105924.
4. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends (Sandeep Kumar Vashist, 2020 April 05: diagnostics)
5. Nano Research for COVID-19 (http://dx.doi.org/10.1021/acsnano.0c02540)
6. Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid
   Detection of the Virus that Causes COVID-19 in Patients (Stephen M, Hahn M.D. 2020 May 09: Commisioner of Food and Drugs
7. Current Intelligence Bulletin 13: Explosive Azide Hazard DHHS (NIOSH) Publication Number 78-127 August 16, 1976
8. CDC. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings (Interim Guidance). (2020).
9. CDC. Duration of Isolation and Precautions for Adults with COVID-19. (2020).
10. Bullard, et al. Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 From
    Diagnostic Samples. CID. 2020; Nov 15;71 (10); DOI:10.1093/cid/ciaa638

GLOSSARY OF SYMBOLS

	Temperature limitation
	For in vitro diagnostic use only
	Do not reuse
	Do not use if package is damaged

	Lot Number
	Catalog Number
	Consult instructions for use
	Keep dry
	Biological Risks
	Use By

	Manufacturer
	Date of manufacture
	Keep away from sunlight
	CE mark
	Contains sufficient for X tests
	Caution

			Sterilized using ethylene oxide
			Sterilized using irradiation
			Do not re-sterilize
			Negative control
			Positive control

TECHNICAL SUPPORT

Abbott Rapid Diagnostics Jena GmbH Orlaweg 1, D-07743 Jena, Germany
abbott.com/poct

Date Issued : 2021.01
41FK11/41FK21-01-EN-A1

2021 Abbott. All rights reserved.
All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.

References

• Rapid Diagnostics | Abbott Point of Care