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R0873 - customer artwork, package insert, 3m flu a+b test _50195_ - rev2r0 _34-8702-8078-1 [november 2009]_.doc

FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test 3M™ Rapid Detection Flu A+B Test
IVD FOR IN VITRO DIAGNOSTIC USE INTENDED USE
The 3M™ Rapid Detection Flu A+B Test is a qualitative immunochromatographic assay used to identify the presence of Influenza A and Influenza B nucleoprotein antigens in nasal wash, nasal aspirate, nasopharyngeal aspirate, and nasopharyngeal swab specimens from symptomatic patients. It is an in vitro diagnostic assay that aids in the rapid differential diagnosis of influenza viral infections in symptomatic patients. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test performance characteristics for Influenza B were established primarily
with retrospective, frozen specimens. Users may wish to further evaluate the
sensitivity performance of this test for Influenza B using fresh samples.
SUMMARY AND EXPLANATION OF THE TEST
Influenza is a highly contagious viral infection of the respiratory tract. It is a seasonal infection that is transmitted through the coughing and sneezing of aerosolized droplets containing live influenza viruses. There are three different types of influenza viruses; A, B and C. Type A viruses are the most prevalent and are associated with the most serious epidemics. Type B viruses are associated with milder epidemics than type A. Type C has never been associated with a large epidemic of human disease1. Influenza A and B can be detected in human respiratory samples by a variety of methods including tissue culture, immunofluorescent assay and enzyme immunoassay. The 3M Rapid Detection Flu A+B Test is a rapid lateral-flow immunoassay that can be utilized to aid in the differential diagnosis of Influenza A and Influenza B. PRINCIPLES OF THE TEST
The 3M Rapid Detection Flu A+B Test is a qualitative immunochromatographic test that utilizes the 3M™ Rapid Detection Reader for the differential determination of Influenza A and Influenza B in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples. A wash/aspirate or swab sample is added to the Sample Buffer. The Sample Buffer is optimized to improve binding of the anti-influenza antibodies to the nucleoprotein antigens and reduce non-specific binding and fluorescent signal background. This sample is then mixed with the Assay Tip containing fluorescent-dyed particles conjugated to specific antibodies and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed particles coated with anti-Influenza A and anti-Influenza B antibodies bind to Influenza A or B nucleoprotein antigens, respectively, if present in the sample. As the sample migrates along the strip, Influenza-bound particles are captured by either anti-Influenza A or anti-Influenza B nucleoprotein monoclonal antibodies at the respective detection zone. Excess fluorescent-dyed particles are captured at the internal standard zone. The Reader then measures the amount of fluorescence emitted by the complexes at the two detection zones (Influenza A and Influenza B) and at the internal standard zone. 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test The instrument calculates a ratio (RAMP® Ratio) of each influenza detection zone (A or B) fluorescence reading to the internal standard zone fluorescence reading. The Reader then compares these ratios to pre-defined threshold limits to determine a positive or negative result for Influenza A and Influenza B in the tested sample. REAGENTS AND MATERIALS PROVIDED
The 3M Rapid Detection Flu A+B Test kit contains all the reagents necessary for the detection
of Influenza A and Influenza B nucleoprotein antigens in nasopharyngeal swab, nasopharyngeal
aspirate, and nasal wash/aspirate samples. The 3M Rapid Detection Flu A+B Test kit should be
stored at 15-30ºC. Do not freeze. Kit contents are stable until the expiration date printed on the
box.
§ Test Cartridge
Individually foil pouched with desiccant. Contains membrane coated with monoclonal antibodies targeting the Influenza A and B nucleoproteins. § Assay Tip
Packaged with Test Cartridge. Polypropylene tips containing fluorescent particles coated with monoclonal antibodies targeting the Influenza A and B nucleoproteins (contains azide as a preservative). § Sample Buffer Vial
Containing phosphate buffer, animal protein, surfactant and ProClin® 300/ ProClin® 900 as preservatives. (contains 150 µL) § Disposable Dropper
Fixed-volume Disposable Bulb Dropper used to transfer sample to the test Sample Buffer vial. (delivers 150 µL) § Transfer Device
Fixed volume device used to transfer sample mixed with sample buffer into Test Cartridge. (delivers 75 µL) § Positive Control Swab
Individually foil pouched with desiccant. Swab coated with non-infectious Influenza A and Influenza B antigen (gamma irradiated). § Negative Control Swab
Individually foil pouched with desiccant. Swab coated with non-infectious protein stabilizer solution. § Lot Card
Stored in anti-static protective pouch. § Package Insert
§ Procedure Card
3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test MATERIALS REQUIRED BUT NOT PROVIDED
§ 3M Rapid Detection Reader
§ Viral Transport Media (VTM) for swab sample elution. Refer to the SPECIMEN
COLLECTION AND HANDLING section. § Specimen collection materials (swab, wash/aspirate container)
§ Disposable gloves

OPTIONAL MATERIALS
§ 3M™ Rapid Detection Flu A+B Control Swabs, REF 3262, (5 Positive, 5 Negative).
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic use. 2. The device contains material of animal origin and should be handled as a potential 3. Do not use the Sample Buffer if it is turbid. Turbidity may be a sign of microbial 4. Failure to follow documented procedures may result in invalid and/or erroneous results. Read the entire Package Insert prior to use. 5. Influenza virus antigens are relatively unstable. Care should be taken to store samples as indicated in SPECIMEN COLLECTION AND PREPARATION. 6. ProClin® is a potential skin sensitizer. Avoid spilling or splashing reagents containing ProClin® on skin or clothing. In case of contact, thoroughly flush with water. 7. Dispose of opened, unused Test Cartridges, Assay Tips, and Control Swabs within 60 8. Discard and do not use any visibly damaged cartridges, or the contents of any Test
Cartridge, Assay Tip, or Control Swab pouch with a damaged seal. Do not use Test Cartridge, Assay Tip, or Control Swab if desiccant is missing from pouch. 9. Do not use kit contents beyond their expiration date. 10. Do not interchange or mix test components from different kit lots. 11. Use the provided Assay Tip and other test components as directed in the Test 12. Assay Tips included in the 3M Rapid Detection Flu A+B Test contain 0.02% (w/v) of sodium azide. Sodium azide is a skin irritant. Avoid skin contact. Disposal of reagents containing sodium azide into drains consisting of lead or copper plumbing can result in the formation of explosive metal oxides. Eliminate build-up of oxides by flushing drains with large volumes of water during disposal. 13. Positive Control Swabs contain inactivated Influenza A and Influenza B viruses and should be handled as if potentially infectious. 14. The 3M Rapid Detection Flu A+B Test Cartridge, Disposable Dropper, Assay Tip, Control Swabs and Sample Buffer Vial should be discarded after single-use. Do not
reuse.
15. Do not insert a Test Cartridge that is wet into the Reader, as this may cause contamination or damage to the Reader. 16. Some patient specimens contain infectious agents; therefore all patient specimens should be handled and discarded as if they are biologically hazardous. Use appropriate precautions in the collection, handling, storage and disposal of clinical specimens, including swabs, and used kit contents. Refer to institutional guidelines for biological waste management. 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test 17. All respiratory samples must be mixed thoroughly before testing, regardless of consistency, to ensure a representative sample prior to testing. 18. Performance characteristics for Influenza A were established when Influenza A/H3 and A/H1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. 19. The test performance characteristics for Influenza B were established primarily with retrospective, frozen specimens. Users may wish to further evaluate the sensitivity performance of this test for Influenza B using fresh samples. 20. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens
should be collected with appropriate infection control precautions for novel virulent
influenza viruses and sent to state or local health departments for testing. Viral culture
should not be attempted in these cases unless a BSL 3+ facility is available to
receive and culture specimens.
21. 3M Rapid Detection Flu A+B "dual positive" specimens (Influenza A and Influenza B positive) should be re-tested. Repeatable Influenza A and B dual positive results should be confirmed by cell culture testing. During the 3M Rapid Detection Flu A+B Test clinical trial, all of the nine 3M Rapid Detection Flu A+B Test "dual positive" nasopharyngeal swab specimens and the two 3M Rapid Detection Flu A+B Test "dual positive" nasal wash/aspirate specimens were confirmed as negative by cell culture. 22. Store this product at 15-30ºC when not in use. Do not freeze.
SPECIMEN COLLECTION AND PREPARATION
NOTE: Proper specimen collection, storage, and transport are critical to the performance
of this test. Inadequate or inappropriate specimen collection, storage, and/or transport
could potentially yield false negative results. Appropriate training in specimen collection
is highly recommended to ensure specimen quality.
WARNING: Specimens contaminated with blood (>2% v/v) may interfere with the
interpretation of test results. Do not use specimens that are visibly contaminated (>2%
v/v) with blood.
For best test results specimens should be tested as soon as possible. If samples are not
tested immediately, they should be stored at 2-8ºC. Specimens may be held up to 72 hours at
2-8ºC prior to testing.
Transport Media
The following Transport Media are recommended and have been tested and shown not to interfere with the performance of the test. • Copan Universal Transport Media (UTM) • Remel® M5 Media • Starplex® Transport Media • Normal Saline Solution • Phosphate Buffered Saline (PBS) Solution Remel® M4 and M4-RT Transport Media ARE NOT recommended for use with this test. 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test Nasopharyngeal Swab Sample
For nasopharyngeal swabs, use sterile foam, polyester, nylon, or rayon swabs. Calcium
alginate swabs are not recommended2. It is important to obtain as much secretion as
possible. Keep the sterile swab near the septum floor of the nose while gently pushing the
swab into the posterior nasopharynx and rotate several times. Remove the specimen from the
swab into 0.5 to 3.0 mL of recommended transport media by vigorously rotating the swab in the
liquid. Continue to TEST PROCEDURE.
Nasal Wash/Aspirate Sample
Pour up to 2.5 mL of saline solution into a sterile specimen container. Draw up saline solution into the syringe or aspiration bulb. Insert the tip (of the syringe or aspiration bulb) into the nasal cavity. Inject saline solution toward the back of the nasopharyngeal area. Aspirate saline solution, mucous, and epithelial cells back into the syringe or aspirate bulb. Place the acquired specimen into the sterile specimen cup. Repeat for the other nostril and collect fluid in the same specimen container. Nasal wash/aspirate does not require further preparation. Continue to TEST PROCEDURE. Nasopharyngeal Aspirate Sample
Fill aspiration bulb or bulb syringe with up to 2.5 mL of saline solution and inject the saline solution into one nostril with the head tilted back. Release the pressure on the bulb to aspirate the specimen back into the bulb. Transfer the specimen into a clean, dry specimen container. Repeat for the other nostril and collect the fluid into the same specimen container. Nasopharyngeal aspirate does not require further preparation. Continue to TEST PROCEDURE. CALIBRATION PROCEDURE
Each 3M Rapid Detection Flu A+B Test kit includes a Lot Card that is individually packaged in an anti-static pouch. The Lot Card provides information specific to the kit lot, including lot number, expiration date and threshold information. For further details on loading lot-specific information, see the 3M Rapid Detection Reader Operator Manual. No additional calibration, beyond the insertion of the Lot Card is necessary. This operation is required only once per test kit lot. WARNING: Avoid touching the contacts at the end of the Lot Card.
For additional information please refer to the 3M Rapid Detection Reader Operator EXTERNAL QUALITY CONTROL SWAB PROCEDURE
NOTE: Do not extract the Control Swabs directly into the Sample Buffer Vials.
The Positive and Negative Control Swabs are designed to be eluted into viral transport
media used for patient samples.
1. Obtain a vial of viral transport media (0.5-3.0 mL).
2. Open and remove Control Swab (positive or negative) from pouch.
3. Insert foam end of Control Swab into transport media.
4. Rotate the swab in liquid vigorously for 10 seconds.
5. Press swab against the side of the vial as it is removed.
6. Discard swab in appropriate container.
7. Follow the TEST PROCEDURE to test this liquid quality control (LQC) sample.
3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test TEST PROCEDURE
This test should be performed by qualified personnel per local, state or federal regulations or
accrediting agency requirements.
NOTE: If stored at 2-8ºC prior to sample analysis, allow samples to equilibrate to room
temperature for at least 15 minutes.
You will need the Transfer Device and for each sample being tested, one Disposable Dropper, one Sample Buffer Vial and a pouch containing one Test Cartridge and one Assay Tip. 1. Prepare Reader for Test Cartridge. Refer to the 3M Rapid Detection Reader Operator Manual for detailed instructions on Starting a Test or Running LQC.
NOTE: When preparing the Reader for Running LQC the Operator is prompted to
enter the Control ID. The default Control ID is POS for the Positive Control. The
default Control ID is NEG for the Negative Control.
2. Ensure that the specimen is well mixed.
3. Place Sample Buffer Vial upright on a clean, dry, level surface or in a sample vial holder.
Ensure all liquid is at the bottom of the vial and remove the lid. 4. Firmly squeeze the top bulb on a new Disposable Dropper. Place the tip of the Dropper into the specimen and release the bulb to fill the Dropper with 150 µL of the specimen. 5. Ensure there are no air bubbles in lower stem of Dropper. Insert lower stem of
Dropper into Sample Buffer Vial and squeeze top bulb to transfer sample into Sample Buffer Vial. Dispose of used Dropper. 6. Open pouch containing Test Cartridge and Assay Tip. Place Test Cartridge on clean, dry, level surface. 7. Firmly attach Assay Tip to the supplied Transfer Device. 8. Using the Transfer Device (75 μL), insert Assay Tip into Sample Buffer Vial close to, but not touching bottom of vial. Do not press against the bottom of vial as this may block tip. 9. Mix sample slowly by pressing and releasing Transfer Device plunger 10 times (2 seconds per cycle), taking care each time to eject entire sample into Sample Buffer Vial and to draw only liquid and no air into Assay Tip. This will prevent foaming. 10. Position filled Assay Tip directly over sample well of Test Cartridge and fully depress plunger to dispense mixed sample into sample well. (Disregard any remaining droplet in Assay Tip.) Dispose of used Assay Tip and Sample Buffer Vial according to local biohazard procedures. 11. Immediately (within 30 seconds) insert Test Cartridge into Reader, and press until firm resistance is felt. Delay will lead to an error message. 12. Do not insert a Test Cartridge that is wet into the Reader, as this may cause contamination or damage to the Reader. See the 3M Rapid Detection Reader Operator Manual for appropriate cleaning procedure. 13. Test result is complete approximately 15 minutes from Test Cartridge insertion. 14. Record the results. 15. Remove the used Test Cartridge when test is completed and results have been recorded. Dispose of used Test Cartridge according to local biohazard procedures. For additional information on the operation of the Reader, please refer to the 3M Rapid Detection Reader Operator Manual. Refer to the 3M Rapid Detection Reader Operator Manual Troubleshooting section for full description of all Messages. If repeated tests give unexpected or inconsistent results, contact 3M Health Care Helpline 1-800-228-3957; or outside the US and Canada, contact your local 3M Subsidiary for assistance. 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test INTERPRETATION OF RESULTS
Negative Result: The Reader screen will display "Flu A NEG" and "Flu B NEG".
Positive Result for Influenza A: The Reader screen will display "Flu A POS" and "Flu B NEG".
Positive Result for Influenza B: The Reader screen will display "Flu A NEG" and "Flu B POS".
Positive Result for Influenza A and B: The Reader screen will display "Flu A POS" and "Flu B
POS".
NOTE: Co-infection with Influenza A and B is rare. 3M Rapid Detection Flu A+B Test "dual
positive" clinical specimens (Influenza A and Influenza B positive) should be re-tested.
Repeatable Influenza A and B "dual positive" results should be confirmed by cell culture testing
before reporting results.
REPORTING OF RESULTS
Negative Result for Influenza A and B: Report negative test results as Influenza A and B
virus antigen not detected. This result does not exclude influenza viral infection. A negative
test is presumptive and it is recommended these results be confirmed by cell culture.
Positive Result for Influenza A and/or B: Report positive test results as Positive for Influenza
A and/or B virus antigen. This result does not rule out co-infections with other pathogens or
identify a specific Influenza A virus subtype.
QUALITY CONTROL
Refer to the 3M Rapid Detection Reader Operator Manual for full details on quality control measures and troubleshooting. System Quality Control
§ The instrument has error checking and self-diagnostic functions that assure procedural
control. These include algorithms and measurements used to confirm acceptable operator technique, sample handling and test performance. § If a problem is detected, a message is displayed. Contact the 3M Health Care Helpline (1-800-228-3957) for assistance, or outside the US and Canada, contact your local 3M Subsidiary for assistance. § Valid results are displayed only after all performance requirements have been met. Procedural Controls
The 3M Rapid Detection Flu A+B Test has built-in (procedural) controls. Each Test Cartridge has an internal standard zone that is scanned as part of the test protocol to ensure proper sample flow. Control limits for each lot of Test Cartridges are established during the manufacturing process and are incorporated in the specific Lot Card. If a control result does not meet specifications, the sample result is not reported and a message is displayed. External Positive and Negative Control Swabs
See section on EXTERNAL QUALITY CONTROL SWAB PROCEDURE for instructions on performing these control tests. § The reactivity of each new lot and of each new shipment of 3M Rapid Detection Flu
A+B Test kits should be verified on receipt using external Positive and Negative
Control Swabs. Additional external positive and negative control testing may be
required in accordance with applicable local, state and/or federal guidelines or
3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test accreditation requirements and each facility's standard Quality Control procedures.
Additional 3M Rapid Detection Flu A+B Control Swabs (REF 3262) are available from
3M.
§ These controls are used to monitor reagent reactivity. Failure of the controls to produce the expected results can mean that one of the reagents or components is no longer reactive at the time of use, the test was not performed correctly or that reagents or samples were not added. If the control tests do not produce the expected result, repeat with fresh Control Swabs and fresh test components. Do not perform patient tests or report patient test results if the control tests do not produce the expected results. For assistance in troubleshooting contact the 3M Health Care Helpline (1-800-228-3957) or outside the US and Canada, contact your local 3M Subsidiary. § Positive and negative tests are described in the section on INTERPRETATION OF RESULTS. Positive Control Swab, contains Influenza A and B antigens, is expected to display "Flu A POS" and "Flu B POS". Negative Control Swab is expected to display "Flu A NEG" and "Flu B NEG". It is a control failure when the Control Swabs do not produce expected results. The external Positive and Negative Control Swabs manufactured for this test are prepared in a simulated sample matrix, which may not mimic test specimens. If external control materials that are identical in composition to test specimens are preferred, the user can prepare those by using known positive and negative specimens in saline solution according to the SPECIMEN COLLECTION AND PREPARATION section of this insert. For further information regarding matrix effects refer to The Clinical Laboratory Standards Institute (CLSI) guideline on matrix effects EP14-A2. LIMITATIONS
1. The 3M Rapid Detection Flu A+B Test can only be used with the 3M Rapid Detection 2. Additional testing is required to differentiate any specific Influenza A subtypes or strains, in consultation with state or local public health departments. 3. Children tend to shed virus more abundantly and for longer periods of time than adults. Therefore, testing specimens from adults may yield lower sensitivity than testing specimens from children. 4. Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely during peak activity when prevalence of disease is high. False positive test results are more likely during periods of low influenza activity when prevalence is moderate to low. 5. Individuals who have received nasal administered Influenza A vaccine may test positive in commercially available influenza rapid diagnostic tests for up to three days after vaccination. 6. Tests using monoclonal antibodies may fail to detect, or detect with less sensitivity, Influenza A viruses that have undergone minor amino acid changes in the target epitope region. 7. Sample types, swabs or viral transport media other than those listed have not been evaluated and should not be used. 8. The 3M Rapid Detection Flu A+B Test detects both viable and non-viable Influenza A and Influenza B viruses. Test performance depends on antigen load and may not correlate with cell culture results. 9. The test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures. 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test 10. A test result that is inconsistent with the clinical signs and symptoms should be interpreted with caution. 11. Samples contaminated with whole blood >2% v/v (visibly bloody samples) may interfere in the interpretation of the test and should not be used. 12. Inadequate or improper sample handling/transport may yield a false-negative result. 13. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. EXPECTED VALUES
The prevalence of influenza varies each year with epidemics occurring during the fall and winter months in the US. Variables that affect the rate of positivity observed in respiratory testing include: the efficiency and timing of specimen collection, handling and transport of the specimen, the time of year, age of the patient, and local disease prevalence. During the 2006-2007 US respiratory season, the combined prevalence of Influenza A and Influenza B was 13.2%4. In the 2007 the 3M Rapid Detection Flu A+B Test multi-center clinical study (samples collected between January and April), the prevalence as observed with culture of Influenza A was 13.2% (111/844); Influenza B was 2.5% (21/844). PERFORMANCE CHARACTERISTICS
CLINICAL STUDIES
NOTE: Performance characteristics for Influenza A were established when Influenza A/H3 and
A/H1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses
are emerging, performance characteristics may vary.

The performance of the 3M Rapid Detection Flu A+B Test was compared to cell culture in a
prospective study conducted as part of a multi-center trial in North America during the 2006-
2007 influenza season when Influenza A/H3 (36.5%) and A/H1 (63.5%) were the predominant
Influenza A viruses in circulation5. Four independent laboratories (located in distinct geographic
regions) evaluated the 3M Rapid Detection Flu A+B Test in parallel with cell culture. Eight
hundred forty-four (844) fresh specimens (nasal wash/aspirate, nasopharyngeal aspirate, or
nasopharyngeal swab samples) prospectively collected during the 2006-2007 influenza season
were tested. Across the sites these samples were drawn from an approximately equal mix of
pediatric (0 – 21 years) and adult patients (21+ years) with approximately equal numbers of
male and female patients. The mean (standard deviation) age of the patients was 28.6 (30.7)
years. In order to supplement the prospective study, performance of the 3M Rapid Detection Flu
A+B Test was also evaluated by two independent laboratories comparing to the original cell
culture testing results (cell culture testing was performed using fresh specimens) on 75
retrospective frozen clinical nasopharyngeal swab samples and 130 retrospective frozen clinical
wash/aspirate samples. The results of the prospective and the retrospective trials based on
specimen type are given in Tables 1-4.
3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test Prospective Study
Table 1. Results with Prospective Nasopharyngeal Swab Samples
Prospective
Influenza A
Influenza B
Tissue Culture
Positive
Negative
Positive
Negative
Positive
Negative
Sensitivity
Specificity

Table 2. Results with Prospective Wash/Aspirate Samples
Prospective Fresh
Influenza A
Influenza B
Tissue Culture
Positive
Negative
Positive
Negative
Positive
Negative
Sensitivity
Specificity
Retrospective Study
Table 3. Results with Retrospective Nasopharyngeal Swab Samples
Influenza A
Influenza B
Tissue Culture
Positive
Negative
Positive
Negative
Positive
Negative
Positive Percent
Agreement
Negative Percent
Agreement

Table 4. Results with Retrospective Wash/Aspirate Samples
Frozen Nasal
Influenza A
Influenza B
Tissue Culture
Positive
Negative
Positive
Negative
Positive
Negative
Positive Percent
Agreement
Negative Percent
Agreement
3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test The reproducibility of the 3M Rapid Detection Flu A+B Test was evaluated using a panel of 6
simulated samples that included high negative, low positive (the test LoD) and moderate
positive (2 X the test LoD) Influenza A or Influenza B samples. The influenza strains used to
prepare the simulated samples were Influenza A/Hong Kong/8/68 and Influenza B/Lee/40. The
influenza strains were re-titered prior to testing. Panel samples were tested in triplicates at each
of the 3 testing sites by 2 operators for 5 days using a single lot of the 3M Rapid Detection Flu
A+B Test (6 samples X 3 replicates X 2 operators X 5 days X 3 sites = 540). The overall percent
agreement for the 3M Rapid Detection Flu A+B Test was 100%, with no significant differences
within run (same operator on same day), between run, operators, and sites. The results of the
reproducibility study are given in Table 5.

Table 5. Reproducibility Study Results
Influenza A
Influenza A
Influenza A
Influenza B
Influenza B
Influenza B
Negative
Positive
Positive
Negative
Positive
Positive
Agreement
Ratio* Value % CV Ratio* Value % CV Ratio* Value % CV *RAMP® Ratios are for reference only. These values are not reported by the instrument. 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test Whole blood and a number of other potentially interfering substances (medications and over the counter (OTC) products) that may be present naturally or artificially introduced in the nasal cavity or nasopharynx were evaluated in the 3M Rapid Detection Flu A+B Test. The substances were added to a simulated negative sample (viral transport media), an Influenza A LoD positive sample, an Influenza A 2x LoD positive sample, an Influenza B LoD positive sample and an Influenza B 2x LoD positive sample and tested at n=3 replicates each in the 3M Rapid Detection Flu A+B Test. The influenza strains used to prepare the samples were Influenza A/Hong Kong/8/68 and Influenza B/Lee/40. These influenza strains were re-titered prior to interference testing. The following substances were found to have no effect on 3M Rapid Detection Flu A+B Test results when present in simulated respiratory samples at the concentrations indicated: Halls® Throat Drop (15% w/v), Cepacol® Throat Drop (15% w/v), Fisherman's Friend® Throat Drop 4-Acetamidophenol Chlorpheniramine (5mg/ml), Diphenylhydramine (5mg/ml), Phenylpropanol-amine HCl (20mg/ml), Oseltamivir Phosphate (Tamiflu) (50mg/ml), Rimantadine HCl (500ng/ml), Ribavirin (Rebetol) (100ng/ml), Scope® Mouthwash (20% v/v), Cepacol® Mouthwash (20% v/v), Good and Kind Mouthwash (20% v/v), Flonase Nasal Spray (15% v/v), Rhinocort® Nasal Spray (15% v/v), Nasonex® Nasal Spray (15% v/v), Oxymetazoline HCl (0.05% v/v), Phenylephrine HCl (10mg/ml), Guaiacol Glycerol Ether (Benylin) (20mg/ml), Dextromethorphan (2mg/ml), Salbutamol Sulfate (400ng/ml), Whole Blood (2% v/v). ANALYTICAL SENSITIVITY

The analytical sensitivity (limit of detection or LoD) of the 3M Rapid Detection Flu A+B Test was
determined using quantified (EID50/mL) cultures of 2 Influenza A (1 H1N1 and 1 H3N2) and 2
Influenza B strains serially diluted in either viral transfer media (VTM) to simulate a swab
sample type or phosphate buffered saline (PBS) solution to simulate a wash/aspirate sample
type. The influenza strains were re-titered prior to testing. Each viral strain was tested in
replicates of 20 per concentration of virus. The results of the analytical sensitivity study are
presented in the table below. Analytical sensitivity (LoD) was defined as the lowest
concentration, at which ≥ 95% of all replicates tested positive.
Viral Strain
LoD Concentration
Influenza A/Hong Kong/8/68 (H3N2), ATCC VR-544 in VTM Influenza A/Hong Kong/8/68 (H3N2), ATCC VR-544 in PBS Influenza A/PR/8/34 (H1N1), ATCC VR-95 in VTM Influenza A/PR/8/34 (H1N1), ATCC VR-95 in PBS Influenza B/Lee/40, ATCC VR-101 in VTM Influenza B/Lee/40, ATCC VR-101 in PBS Influenza B/Allen/45, ATCC VR-102 in VTM Influenza B/Allen/45, ATCC VR-102 in PBS 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test ANALYTICAL REACTIVITY

The analytical reactivity of the 3M Rapid Detection Flu A+B Test was evaluated against multiple
strains of Influenza A (H1N1 and H3N2 subtypes) and Influenza B. The panel consisted of 4
Influenza A subtype H1N1, 2 Influenza A subtype H3N2, and 3 Influenza B strains. 5 replicates
were tested for each viral strain. The influenza strains were re-titered prior to testing. The results
of the analytical reactivity study are presented in the table below.
Reactivity Concentration
Influenza A/FM/1/47 (H1N1) 3.0 X 103 EID50/mL Influenza A/NWS/33 (H1N1) 3.0 X 102 EID50/mL Influenza A/Swine NY/02/2009 (H1N1)* 1.0 X 102 TCID50/mL Influenza A/New Jersey/8/76 (H1N1) 3.0 X 102 EID50/mL Influenza A/Aichi/2/68 (H3N2) 9.0 X 102 EID50/mL Influenza A/Victoria/3/75 (H3N2) 9.0 X 102 EID50/mL Influenza B/GL/1739/54 9.5 X 103 EID50/mL Influenza B/Taiwan/2/62 1.6 X 101 EID50/mL Influenza B/Hong Kong/5/72 6.3 X 103 EID50/mL
*Although the 3M Rapid Detection Flu A+B Test has been shown to detect the 2009 H1N1
influenza virus in one culture isolate, the performance characteristics of this device with clinical
specimens that are positive for the 2009 H1N1 influenza virus have not been established. The
3M Rapid Detection Flu A+B Test can distinguish between influenza A and B viruses, but it
cannot differentiate influenza subtypes.

NOTE: The performance characteristics of this test with cultured avian Influenza A subtype
H5N1 virus, or with specimens from humans infected with H5N1 or other avian influenza viruses
are unknown.
CROSS REACTIVITY

The analytical specificity of the 3M Rapid Detection Flu A+B Test was evaluated by testing a
panel consisting of 15 viruses and 17 bacteria that may be present in the nasal cavity or
nasopharynx. Bacterial isolates were tested at 106 cfu/mL and viral isolates were tested at
104.75- 105.23 TCID50/mL at n=3 replicates each. The bacterial and viral organisms were re-grown
and re-titered prior to cross-reactivity testing. The results of the analytical specificity study are
presented in the table below.
Flu A result
Flu B result
Adenovirus, Type 1 Adenovirus, Type 7a 105.15 TCID50/mL Respiratory Syncytial Virus (RSV) Human coronavirus, strain OC43 Human coronavirus Strain 229E 105.23 TCID50/mL 105.15 TCID50/mL Enterovirus, Type 68 105.15 TCID50/mL Epstein Barr Virus 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test Flu A result
Flu B result
Human Parainfluenza, Type 1 104.75 TCID50/mL Human Parainfluenza, Type 2 Human Parainfluenza, Type 3 Human metapneumovirus Human Rhinovirus, Strain 1A Bordetella pertussis Corynebacterium Sp. Escherichia coli Haemophilus influenzae Lactobacillus casei Legionella pneumophila Moraxella catarrhalis Mycobacterium tuberculosis avirulent Mycoplasma pneumoniae Neisseria menigitidis Neisseria sicca Psudomonas aeruginosa Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus salivarius Staphylococcus epidermidis Staphylococcus aureus (Protein A producer) NOTE: 3M Rapid Detection Flu A+B Test potential cross-reactivity with Chlamydophilia
pneumoniae has not been determined.
ASSISTANCE
If you have any questions regarding the use of this product please contact the 3M Health Care
Helpline number 1-800-228-3957. If outside the United States or Canada, contact your local 3M
subsidiary for assistance.
REFERENCES
1 Types of Influenza Viruses page. Centers for Disease Control and Prevention Web site.
Available at:. Accessed May 23, 2008. 2 Lauer BA, Masters HB. Toxic effect of calcium alginate swabs on Neisseria gonorrhoeae. J Clinical Microbiol. 1988 Jan;26(1):54–56. 3 Clinical and Laboratory Standards Institute. Evaluation of Matrix Effects; Approved Guideline-Second edition. Document EP-14A2. Wayne, PA: Clinical and Laboratory Standards and Institute; 2005. 3M™ Rapid Detection Flu A+B Test Package Insert FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test 4 Centers for Disease Control and Prevention. Update: Influenza Activity--United States and Worldwide, 2006-07 Season, and Composition of the 2007-08 Influenza Vaccine. MMWR 2007;56(31);789-794. 5 Weekly Report: Influenza Summary Update: Week ending May 19, 2007 – Week 20. Centers for Disease Control and Prevention Web site. Available at: . Accessed May 23, 2008.
EXPLANATION OF SYMBOLS
Definition
Consult Instructions for Use Caution, Consult Accompanying Documents In vitro diagnostic medical device Contains sufficient for <n> tests Temperature limitation Do not use if package damaged Positive control Negative control Authorized European Representative 3M™ Rapid Detection Flu A+B Test Package Insert

FOR INFORMATIONAL USE ONLY. Not to be used for performing assay. Refer to most current package insert accompanying your test 3261 3M™ Rapid Detection Flu A+B Test – 25 tests Made in Canada for
3M Health Care
St. Paul, MN U.S.A.

3M Health Care
D-41453 Neuss, Germany
3M 2009 All rights reserved
3M is a trademark of 3M.
RAMP® Technology is a registered trademark of Response Biomedical
Corporation.
ProClin® is a registered trademark of Rohm and Haas Company.
34-8704-3078-1 [November 2009] 3M™ Rapid Detection Flu A+B Test Package Insert

Source: http://multimedia.3m.com/mws/media/519508O/package-insert-3mtm-rapid-detection-flu-ab-test.pdf