Abbott Panbio COVID-19/Flu A and B Rapid Panel User Manual

Abbott Panbio COVID-19/Flu A and B Rapid Panel User Manual

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 virus.2 It is spread by human-to-human transmission via droplets or direct contact. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough.3 Influenza, commonly called “the flu”, is an infectious disease caused by influenza viruses.4 The symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms typically begin 1-4 days after exposure to the virus and last for about 2-8 days.5

Test Principle

Panbio™ COVID-19/Flu A&B Rapid Panel (Nasopharyngeal) contains a membrane strip, which is pre-coated with immobilized anti-SARS-CoV-2, anti-Influenza A, and anti-Influenza B antibodies on the test line and mouse monoclonal anti- chicken IgY on the control line. Four types of gold conjugates (monoclonal antibodies specific to SARS-CoV-2, Influenza A, and Influenza B gold conjugates and chicken IgY gold conjugate) move upward on the membrane chromatographically and react with anti-SARS-CoV-2, anti-Influenza A, anti- Influenza B antibodies and pre-coated mouse monoclonal anti-chicken IgY antibody respectively. For a positive result, each pathogen of SARS-CoV-2, Influenza A and Influenza B 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

The Panbio™ COVID-19/Flu A&B Rapid Panel (NP) is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 and Influenza A&B antigen (Ag) in human nasopharyngeal swab specimens from individuals, who meet COVID-19 and/or Influenza clinical and/or epidemiological criteria.

Panbio™ COVID-19/Flu A&B Rapid Panel (NP) is for professional use and is intended to be used as an aid in the diagnosis of SARS-CoV-2 and Influenza infection. The product may be used in laboratory and non-laboratory environment.

The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 and Influenza A&B infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results should be combined with clinical observations, patient history, and epidemiological information.

Materials Provided

• 10 Test devices with desiccant in individual foil pouches
• 10 Extraction buffer tubes in a foil pouch
• 10 Nozzle caps
• 10 Sterilized nasopharyngeal swabs for specimen collection
• 1 Tube rack
• 1 Instructions for Use with Quick Reference Guide

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

• Test device
  Gold conjugate: monoclonal antibodies to SARS-CoV-2 Ag, anti Influenza
  A Ag, and B Ag – gold colloid and Chicken IgY – gold colloid, Test line: Mouse monoclonal anti-SARS-CoV-2, Mouse monoclonal anti-Influenza A and Fragment antigen-binding anti-Influenza B, Control line: Mouse monoclonal anti-Chicken IgY

• Buffer: Tricine, Sodium Chloride, Tween 20, Tergitol 15-S-9, Sodium Azide (<0.1%)

Storage and Stability of Test Kit

1. The test kit should be stored at a temperature between 2 – 30 °C. Do not freeze the kit or its components.
2. 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.
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 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 buffer tube filled with extraction buffer at room temperature (15 – 30°C) for up to 2 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 instructions 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 buffer 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 those for other product.
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 nasopharyngeal specimen collection.
13. To avoid cross-contamination, do not reuse the swabs for specimen collection.
14. Do not dilute the collected swab with any solution except for the provided 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.6

Test Procedure (Refer to Figures)

Nasopharyngeal Swab Specimens

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

1. 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. Remove the test device from the foil pouch. Place on a flat, horizontal and clean surface.
3. Keep extraction buffer tube upright and remove foil. Place the extraction buffer tube in the tube rack.

Nasopharyngeal Specimen Collection & Extraction

1. Tilt the patient’s head back slightly about 45°-70° to straighten the passage from the front of the nose.

2. Insert the swab through the nostril parallel to the palate.
   Caution: Use dedicated nasopharyngeal swab for specimen collection, provided in the kit.

3. 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.

4. Gently rub and roll the swab, 5 times. Leave the swab in place for several seconds to absorb secretions.

5. Slowly remove swab while rotating it and insert into the extraction buffer tube.

6. Swirl the swab tip in the buffer fluid inside the extraction buffer tube, pushing into the wall of the extraction buffer tube at least five times and then squeeze out the swab by squeezing the extraction buffer tube with your fingers.

7. Dispose of the used swab in accordance with your local regulations and biohazard waste disposal protocol.

8. Press the nozzle cap tightly onto the extraction buffer tube.

Reaction with Test Device

1. Dispense 4 drops of extracted specimen vertically into the specimen well on the device.
   Caution: Do not handle or move the test device until the test is complete and ready for reading.

2. Start timer. Read result at 15 minutes. Do not read result before 15 minutes or after 20 minutes.

3. Close the nozzle using cap and dispose of the extraction buffer tube according to your local regulations and biohazard waste disposal protocol.

4. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.

Test Limitations

1. The contents of this kit are to be used for the professional and qualitative detection of SARS-CoV-2 and Influenza A&B antigens from nasopharyngeal 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 and Influenza A&B 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/Flu A&B Rapid Panel (NP) 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.7

8. Positive results may occur in cases of infection with SARS-CoV or Albumin.

9. Panbio™ COVID-19/Flu A&B Rapid Panel (NP) was not evaluated for the following influenza strains as referenced by WHO guideline:
   A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021.

10. Wait 4 hours before repeating the test following an invalid result.

11. Clinical performance was evaluated with frozen samples, and test performance may be different with fresh samples.

Quality Control

Procedural Controls

The test device has a control line (“C”) and test lines (“FLU B”, “FLU A”, “COV 19”) 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 Controls

Good laboratory practice recommends the use of external control materials. Users should follow federal, state and local guidelines concerning the frequency of external control testing. Specific positive controls can be ordered by the following catalogue number: 62FK11C.

Performance Characteristics

Clinical performance with NP Specimen of Panbio™ COVID-19/Flu A &B Rapid Panel (NP)

The Panbio™ COVID-19/Flu A&B Rapid Panel (NP) is designed for nasopharyngeal specimen collection from one nostril. The performance of Panbio™ COVID-19/Flu A&B Rapid Panel (NP) was established with Nasopharyngeal swabs tested in Korea in September 2021 with 100 COVID-19 positives, 50 Influenza A positives, 50 Influenza B positives, and 200 negative specimens for COVID-19 and Influenza A&B antigen.

Samples were collected from subjects who presented with symptoms of Influenza A&B and/or COVID-19. One specimen was collected for testing on Panbio™ COVID-19/Flu A&B Rapid Panel (NP) and another for PCR.
Swabs were collected and extracted into viral transport media. Samples were frozen after collection and thawed before testing. The performance of the Panbio™ COVID-19/Flu A&B Rapid Panel (NP) was evaluated by comparison to a CE- marked RT-PCR method.

The study showed a sensitivity of 88.0% (95% CI: 80.0-93.6%) and specificity of 100.0% (95% CI: 98.2-100.0%) for SARS-CoV-2, a sensitivity of 92.0% (95% CI: 80.8-97.8%) and specificity of 100.0% (95% CI: 98.2-100.0%) for Influenza A, and a sensitivity of 100.0% (95% CI: 92.9-100.0%) and specificity of 100.0% (95% CI: 98.2-100.0%) for Influenza B.

Panbio™ COVID-19/Flu A &B Rapid Panel (NP) Results for NP COVID-19 

SARS-CoV-2| RT-PCR| Overall Sensitivity (95% CI)| Overall Specificity (95% CI)
---|---|---|---
Positive| Negative| Total
Panbio™ COVID-19/ Flu A &B Rapid Panel (NP)| Positive| 88| 0| 88| 88.0% (80.0-93.6%)| 100.0% (98.2- 100.0%)
Negative| 12| 200| 212
Total| 100| 200| 300

• Positive agreement of the Panbio™ COVID-19/Flu A&B Rapid Panel (NP) is higher with specimens of Ct values ≤30 with a sensitivity of 94.4% (95%CI:87.5-98.3%) and lower with specimens of Ct values >30 with a sensitivity of 30.0% (95%CI:6.7-65.3%) for SARS-CoV-2. As suggested in references 7-9, patients with Ct values>30 are no longer contagious.7, 8, 9

Panbio™ COVID-19/Flu A &B Rapid Panel (NP) Results for NP Influenza A

Influenza A| RT-PCR| Overall Sensitivity (95% CI)| Overall Specificity (95% CI)
---|---|---|---
Positive| Negative| Total
Panbio™ COVID-19/ Flu A &B Rapid Panel (NP)| Positive| 46| 0| 46| 92.0% (80.8- 97.8%)| 100.0% (98.2- 100.0%)
Negative| 4| 200| 204
Total| 50| 200| 250

Panbio™ COVID-19/Flu A &B Rapid Panel (NP) Results for NP Influenza B

Influenza B| RT-PCR| Overall Sensitivity (95% CI)| Overall Specificity (95% CI)
---|---|---|---
Positive| Negative| Total
Panbio™ COVID-19/ Flu A &B Rapid Panel (NP)| Positive| 50| 0| 50| 100.0% (92.9- 100.0%)| 100.0% (98.2- 100.0%)
Negative| 0| 200| 200
Total| 50| 200| 250

Detection Limit

The detection limit of the Panbio™ COVID-19/Flu A&B Rapid Panel (NP) was determined on the following virus strains:

• 1.54 X 102 TCID50/ml of SARS-CoV-2 which was isolated from a COVID-19 confirmed patient in Korea.
• 4.07 X 102 TCID50/ml of Influenza A H1N1/California/07/09 strain.
• 1.14 X 102 TCID50/ml of Influenza A H3N2/Perth/16/09.
• 2.46 X 104 IU/ml of Influenza B/Wisconsin/1/2010.

This influenza A viral strains were obtained from ZeptoMetrix with titer information. The performance characteristics for influenza A virus can vary depending on the subtypes, region, and year of occurrence since influenza
A viruses have undergone minor amino acid changes in the target epitope region.

Hook Effect

There is no hook effect at:

• 1.0 X 105.8 TCID50/ml with SARS-CoV-2 culture fluid which was isolated from a COVID-19 confirmed patient in Korea.
• 1.17 X 105 TCID50/ml with Influenza A H1N1/California/07/09.
• 1.17 X 105 TCID50/ml with Influenza A H3N2/Perth/16/09.
• 1.40 X 107 IU/ml with Influenza B/Wisconsin/1/2010.
• 5.0 X 107.25 TCID50/ml with Influenza A H1N1/New Jersey/8/76.
• 3.40 X 109 TCID50/ml with Influenza A/Denver/1/57.
• 5.0 X 106.5 TCID50/ml with Influenza A/Hong Kong/8/68.

Cross Reactivity

Cross-reactivity of Panbio™ COVID-19/Flu A&B Rapid Panel (NP) was evaluated by testing 76 viruses and 37 other microorganisms (5 replicates of each). The human Influenza A strains, as expected, reacted with the Influenza A test line and did not cross react with the influenza B or COVID-19 test lines. The human Influenza B strains, as expected, reacted with the Influenza B test line and did not cross react with the influenza A or COVID-19 test lines. The non-human influenza strains did not react with the Influenza A, B or COVID-19 test lines. Panbio™ COVID-19/Flu A&B Rapid Panel (NP) has cross-reactivity with Human-SARS-coronavirus Nucleoprotein at a concentration of ≥200 pg/ml due to SARS-CoV having a high homology to the SARS-CoV-2 (79.6%).

Tested Viruses

SARS-CoV
Nucleoprotein| Influenza A H1N1 (California/07/09)| Influenza A H1N1 (A/Beijing/262/1995)
Influenza A H1N1 (A/New Jersey/8/76)| Influenza A H1N1 (A/Denver/1/57)| Influenza H1N1 (A/Puerto Rico/8/34)
Influenza A H1N1 (A/ FM/1/47)| Influenza H3N2 (A/Hong Kong/8/68)| Influenza A H3N2 (A/Victoria/3/75)
Influenza A H3N2 (A/Port Chalmers/1/73)| Influenza A H3N2 (Perth/16/09)| Influenza A H3N2 (Wisconsin/67/05)
Influenza A H5N1 (A/ China/2006)| Influenza A H5N2 (A/chicken/ Iowa/ 04-20/2015)| Influenza A H7N1 (A/turkey/ Italy/4602/99)
Influenza A H7N2 (A/ ruddy turnstone/New Jersey/563/2006)| Influenza A H7N7 (A/chicken/ Netherlands/1/03)| Influenza B
(B/Flori- da/78/2015, Victoria Lineage)
Influenza B
(B/ Florida/4/2006, Yamagata Lineage)| Influenza B (B/Maryland/1/59, Victoria Lineage)| Influenza B (B/GL/1739/54)
Influenza B
(B /Taiwan/2/62)| Influenza B (B/Malaysia/2506/04, Victoria Lineage)| Influenza B (B/Wisconsin/1/2010, Yamagata Lineage)
Influenza A H1N1 (A/Wisconsin/588/2019)/ (A/Victoria/2570/2019)| Influenza A H3N2 (A/Cambodia/ e0826360/2020)| Influenza B (B/ Phuket/3073/2013, Yamagata Lineage)
Influenza B (B/ Washington/02/2019, Victoria Lineage)| |

• non-human influenza strain

There was no cross-reaction with the viruses and microorganisms listed below.

Tested Viruses

HCoV-HKU1| HCoV-NL63| HCoV-OC43
MERS-CoV| HCoV-229E| Human adenovirus 1
Human adenovirus 2| Human adenovirus 3| Human adenovirus 4
Human adenovirus 5| Adenovirus 6| Adenovirus 7
Adenovirus 10| Human adenovirus 18| Adenovirus 21
Norovirus| Epstein Barr Virus| Human herpesvirus (HSV) 1
Human herpesvirus (HSV) 2| Human cytomegalovirus| Mumps virus
Parainfluenza virus type 4A| Parainfluenza virus type 4B| Parainfluenza type 1
Parainfluenza type 2| Parainfluenza type 3| Human respiratory syncytial virus A
Human respiratory syncytial virus B| Measles virus| hMPV 16 type A1
Human rhinovirus type 1B| Rhinovirus type A2| Human rhinovirus 14
Rhinovirus A16| Rotavirus A| Sendai virus
Rubella virus| Coxsackievirus A9| Coxsackievirus B4
Coxsackievirus B5| Human echovirus 2| Human echovirus 6
Echovirus 7| Echovirus 11| Human enterovirus 71
Poliovirus 1| Enterovirus D68|
Tested Microorganisms

Bordetella pertussis| Mycobacterium avium| Staphylococcus epidermidis
Candida albicans| Mycobacterium tuberculosis| Staphylococcus haemolyticus
Chlamydophila pneumoniae| Mycoplasma pneumoniae| Staphylococcus saprophyticus
Enterococcus faecalis| Neisseria lactamica| Streptococcus pneumoniae
Escherichia coli| Neisseria gonorrhoeae| Streptococcus pyogenes
Fusobacterium necrophorum| Neisseria meningitidis| Streptococcus salivarius
Haemophilus influenzae| Neisseria sp. (Neisseria lactamica)| Streptococcus anginosus
Klebsiella pneumoniae| Proteus vulgaris| Pneumocytis jirovecci (PJP)
Legionella pneumophila| Pseudomonas aeruginosa| Pooled human nasal wash
Moraxella catarrhalis| Corynebacterium diphtheriae| Enterococcus faecium
Lactobacillus plantarum| Neisseria sicca| Streptococcus agalactiae
Streptococcus bovis| Streptococcus oralis| Arcanobacterium haemolyticum
Staphylococcus aureus| |

Interfering Substances

The following 53 potentially interfering substances (5 replicates of each) have no impact on Panbio™ COVID-19/Flu A&B Rapid Panel (NP) with the exception of Albumin at concentrations >55 g/L.

(Therabreath)
Budesonide| Tamiflu (Oseltamivir)| Guaiacol glyceryl ether| Heparin
Phenylpropanolamine| | |

Repeatability & Reproducibility

Repeatability & Reproducibility of Panbio™ COVID-19/Flu A&B Rapid Panel (NP) was established using 3 positive specimens (moderate, weak, LoD proximity concentration) per each strain (SARS-CoV-2, Influenza A H1N1, Influenza A H3N2, and Influenza B) and negative specimen. There were no differences observed within-run, between-run, between-lots, between-sites, and between- days.

PREPARATION

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.

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 pouch
2. Extraction buffer tube in the foil pouch
3. Nozzle cap
4. Sterilized nasopharyngeal swab for specimen collection
5. Tube rack
6. Instructions for Use with Quick Reference Guide

Carefully read these instructions prior to using Panbio™ COVID-19/Flu A&B Rapid Panel (NP).

Look at the expiration date of the kit box. If the expiration date has passed, select another kit for use.

Open the foil pouch of test device and look for the following:

1. Result window
2. Specimen well

Then, label the device with the patient identifier.

TEST PROCEDURE

Keep extraction buffer tube upright and remove foil. Place the extraction buffer tube in the tube rack.

Tilt the patient’s head back (about 45°-70°). Insert the swab through the nostril. Gently rub and roll the swab, 5 times. Leave the swab in place for several seconds. Slowly remove swab.

Insert the swab specimen into the extraction buffer tube. Swirl the swab tip in the buffer fluid inside the extraction buffer tube, pushing into the wall of the extraction buffer tube at least five times and then squeeze out the swab by squeezing the extraction buffer tube with your fingers.

Dispose of the used swab in accordance with your local regulations and biohazard waste disposal protocol.

Press the nozzle cap tightly onto the extraction buffer tube.

Dispense 4 drops of extracted specimen vertically into the specimen well on the device.
Caution: Do not handle or move the test device until the test is complete and ready for reading.

Start timer. Read result at 15 minutes.
Do not read result after 20 minutes.
Note: A Control (“C”) line may appear in the result window in a few minutes but a test line (“FLU B”, “FLU A”, “COV 19”) may take as long as 15 minutes to appear.

Close the nozzle using cap and dispose of the extraction buffer tube according to your local regulations and biohazard waste disposal protocol.

TEST INTERPRETATION

POSITIVE

• COVID-19 positive: The presence of two colored lines (test line “COV 19” and control line “C”) within the result window.

• Influenza A positive: The presence of two colored lines (test line “FLU A” and control line “C”) within the result window.

• Influenza B positive: The presence of two colored lines (test line “FLU B” and control line “C”) within the result window.

• Multi positives: The presence of three or four colored lines (test line “FLU B”, “FLU A”, “COV 19” and control line “C”) within the result window.
  

Caution: The presence of any test line (“FLU B”, “FLU A”, “COV 19”), no matter how faint, indicates a positive result.

Note: In the case of multi-positives, User should be aware of this unique situation as both can present with similar symptoms but vary in treatment.

Note that the test provides preliminary test results.

NEGATIVE

The presence of only the control line (“C”) and no test line (“FLU B”, “FLU A”, “COV 19”) within the result window indicates a negative result.

INVALID

If the control line (“C”) is not visible within the result window after performing the test, the result is considered invalid (even though the test line may be visible).

Instructions may not have been followed correctly. It is recommended to wait 4 hours, read the IFU again and collect a new specimen and re-test using a new test device.

Dispose of the used device according to your local regulations and biohazard waste disposal protocol.

REFERENCES

1. Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. 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 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19):
   The epidemic and the challenges. J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.

4. “Flu Symptoms & Diagnosis”. Centers for Disease Control and Prevention (CDC). 10 July 2019. Retrieved 24 January 2020.

5. “Flu Symptoms & Complications”. Centers for Disease Control and Prevention (CDC). 26 February 2019. Retrieved 6 July 2019.

6. Current Intelligence Bulletin 13: Explosive Azide Hazard DHHS (NIOSH) Publication Number 78-127 August 16, 1976.

7. CDC. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings (Interim Guidance). (2020).

8. CDC. Duration of Isolation of Precautions for Adults with COVID-19 (2020).

9. Bullard, et al. Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 From Diagnostic Samples. Clin Infect Dis. 2020 Dec 17;71(10):2663-2666. 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

TECHNICAL SUPPORT

Europe and Middle East| +44 161 483 9032 EME.TechSupport@abbott.com
---|---
Africa| +27 10 500 9700 arcis.techsupport@abbott.com
Russia and CIS| +7 499 403 9512 arcis.techsupport@abbott.com
Asia Pacific| +61 7 3363 7711 AP.TechSupport@abbott.com
Latin America| +57 60 1794 5968 LA.TechSupport@abbott.com
Canada| +1 800 818 8335 Canproductsupport@abbott.com

Abbott Rapid Diagnostics Jena GmbH
Orlaweg 1, D-07743 Jena, Germany
www.globalpointofcare.abbott

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