(105 days)
Not Found
No
The description focuses on isothermal nucleic acid amplification technology and fluorescence detection, with no mention of AI or ML in the device's operation or data analysis.
No.
The device is an in vitro diagnostic test intended for qualitative detection and discrimination of influenza A and B viral RNA, aiding in differential diagnosis. It does not directly treat or prevent a disease, nor does it restore, modify, or correct body function or structure, which are characteristic functions of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a rapid molecular in vitro diagnostic test" and is "intended for use as an aid in the differential diagnosis of influenza A and B viral infections."
No
The device description explicitly states that the system is comprised of both single-use disposable components (Sample Receiver, Test Base, Transfer Cartridge) and a repeat-use hardware component (Alere™ i Instrument). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Alere™ i Influenza A & B 2 assay is a "rapid molecular in vitro diagnostic test".
- Method: It performs a test "in vitro" (outside the body) on biological specimens (nasal or nasopharyngeal swabs).
- Purpose: The test is used for the "qualitative detection and discrimination of influenza A and B viral RNA" to aid in the "differential diagnosis of influenza A and B viral infections in humans". This is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The Alere™ i Influenza A & B 2 assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2016-2017 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
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 department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Product codes (comma separated list FDA assigned to the subject device)
OCC, OZE, OOI
Device Description
Alere™ i Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swabs tested directly or after elution in viral transport media collected from patients with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B 2 System utilizes isothermal nucleic acid amplification technology and is comprised of:
- Sample Receiver single use, disposable containing the elution buffer
- Test Base single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
- . Transfer Cartridge – Single use, disposable for transfer of the eluted sample to the Test Base, and
- Alere™ i Instrument - repeat use reader
The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B, which occur in two separate reaction tube contains fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets. Alere™ i Influenza A & B 2 is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.
To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, re-suspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating, mixing and detection by fluorescence are provided by the instrument, with results automatically reported.
Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, nasopharyngeal swabs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use, in a medical laboratory or point-of-care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A total of 1110 nasal or nasopharyngeal swab specimens were enrolled in this study. Of those, 36 nasal or nasopharyngeal swab specimens did not meet eligibility criteria. A total of 1074 specimens were tested with Alere™ i Influenza A & B 2. 56% of the population tested was female and 44% was male.
In this study, two nasopharyngeal swabs were collected from each Subject. One swab was tested directly with Alere™ i Influenza A & B 2, according to product instructions for testing direct swabs. The other swab was eluted in VTM, and a sample of the VTM eluate was tested with Alere™ i Influenza A & B 2. An FDA-cleared real-time Polymerase Chain Reaction (RT-PCR) test was utilized as the comparator method for this study.
Of the 1074 specimens, Alere™ i Influenza A & B 2 generated invalid results for 4 direct swab specimens after repeat testing per the product instructions, resulting in a total of 1070 specimens for direct swab performance analysis. Alere™ i Influenza A & B 2 generated invalid results for 11 viral transport media specimens after repeat testing per the product instructions and an additional 6 specimens did not meet eligibility criteria, resulting in a total of 1057 specimens for viral transport media performance analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study
The clinical performance of Alere™ i Influenza A & B 2 was established in a multi-center, prospective clinical study conducted at ten US trial sites during the 2016-2017 respiratory season.
A total of 1110 nasal or nasopharyngeal swab specimens were enrolled in this study. Of those, 36 nasal or nasopharyngeal swab specimens did not meet eligibility criteria. A total of 1074 specimens were tested with Alere™ i Influenza A & B 2. 56% of the population tested was female and 44% was male.
Compared to the comparator method, the performance of Alere™ i Influenza A & B 2 is presented in the tables below.
Direct Nasal or Nasopharyngeal Swab – Performance Obtained for Influenza A with Alere™ i Influenza A & B 2 against the Comparator Method
- Sensitivity: 260/270 = 96.3% (95%CI: 93.3%-98.2%)
- Specificity: 779/800 = 97.4% (95%Cl: 96.0%-98.4%)
Direct Nasal or Nasopharyngeal Swab – Performance Obtained for Influenza B with Alere™ i Influenza A & B 2 against the Comparator Method
- Sensitivity: 97/97 = 100% (95%CI: 96.3%-100%)
- Specificity: 945/973 = 97.1% (95%CI: 95.9%-98.1%)
Nasal or Nasopharyngeal Swab Eluted in Viral Transport Media – Performance Obtained for Influenza A with Alere™ i Influenza A & B 2 against the Comparator Method
- Sensitivity: 246/265 = 92.8% (95%CI: 89.0%-95.6%)
- Specificity: 780/792 = 98.5% (95%CI: 97.4%-99.2%)
Nasal or Nasopharyngeal Swab Eluted in Viral Transport Media – Performance Obtained for Influenza B with Alere™ i Influenza A & B 2 against the Comparator Method
- Sensitivity: 97/97 = 100% (95%CI: 96.3%-100%)
- Specificity: 938/960 = 97.7% (95%CI: 96.6%- 98.6%)
During the prospective clinical study, the initial invalid rate for direct nasal or nasopharyngeal swab samples (before repeat testing per the product instructions) was 0.8% (9/1074) (95% Cl: 0.4% to 1.6%). After repeat testing per the product instructions, the invalid rate was 0.4% (4/1074) (95% Cl: 0.1% to 1.0%).
The initial invalid rate for swabs eluted in viral transport media was 2.2% (24/1074) (95% Cl: 1.5% to 3.2%). After repeat testing per the product instructions, the invalid rate was 1.0% (11/1074) (95% Cl: 0.6%).
Analytical Sensitivity
Alere™ i Influenza A & B 2 limit of detection (LOD or Cos), defined as the concentration of influenza A or B that produces positive Alere™ i Influenza A & B 2 results approximately 95% of the time, was identified by evaluating two influenza A strains and two influenza B strains for both direct swab and swab eluted in VTM testing in Alere™ i Influenza A & B 2.
Reproducibility
A reproducibility study of Alere™ i Influenza A & B 2 was conducted by operators from 3 sites using panels of blind coded specimens containing negative (at the limit of detection), and moderate positive (above the limit of detection) influenza A and B samples. Participants tested each sample multiple times on 5 different days. The percent agreement with expected results for the influenza A moderate positive samples was 100% (90/90). The percent agreement with expected result for the influenza B moderate positive and low positive samples were 100% (89/89), 98.9% (89/90), respectfully. All of the true negative samples (89) generated negative test results. There were no significant differences observed within run (replicates tested by one operator), between run (five different days), between sites (three sites), or between operators (nine operators).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Direct Nasal or Nasopharyngeal Swab – Performance Obtained for Influenza A with Alere™ i Influenza A & B 2 against the Comparator Method
- Sensitivity: 96.3% (95%CI: 93.3%-98.2%)
- Specificity: 97.4% (95%Cl: 96.0%-98.4%)
Direct Nasal or Nasopharyngeal Swab – Performance Obtained for Influenza B with Alere™ i Influenza A & B 2 against the Comparator Method
- Sensitivity: 100% (95%CI: 96.3%-100%)
- Specificity: 97.1% (95%CI: 95.9%-98.1%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Alere™ i Influenza A & B K163266
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
September 29, 2017
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Alere Scarborough, Inc. Angela Drysdale VP, Regulatory Affairs - Infectious Disease 10 Southgate Road Scarborough ME 04074
Re: K171792
Trade/Device Name: Alere i Influenza A & B 2. Alere i Instrument, Alere i Influenza A & B Control Swab Kit Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC, OZE, OOI Dated: June 15, 2017 Received: July 3, 2017
Dear Ms. Drysdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Steven R. Gitterman -S
for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171792
Device Name Alere i Influenza A & B 2
Indications for Use (Describe)
The Alere i Influenza A & B 2 assay performed on the Alere i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2016-2017 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characterics may vary.
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 department for testing. Viral culture should not be attempted in cases unless a BSL 3+ facility is available to receive and culture specimens.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K171792
SUBMITTER
Alere Scarborough, Inc. 10 Southgate Road Scarborough, Maine 04074 Establishment Registration Number: 1221359
CONTACT PERSON
Angela Drysdale (207) 415-1393 (office) (207) 730-5767 (FAX) angela.drysdale@alere.com (email)
DATE PREPARED
June 15, 2017
TRADE NAME Alere™ i Influenza A & B 2
COMMON NAME
Alere™ i Flu, Alere™ i, Alere™ i Flu 2, Alere™ Influenza A & B, Alere™ Influenza A & B 2
CLASSIFICATION NAME
Respiratory Viral Panel Multiplex Nucleic Acid System (per 21 CFR 866.3980) Instrumentation for Clinical Multiplex Test Systems (per 21 CFR 862.2570)
CLASSIFICATION Class II
PRODUCT CODE OCC, OZE, OOI
PANEL Microbiology (83)
PREDICATE DEVICE Alere™ i Influenza A & B K163266
4
DEVICE DESCRIPTION
Alere™ i Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swabs tested directly or after elution in viral transport media collected from patients with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B 2 System utilizes isothermal nucleic acid amplification technology and is comprised of:
- Sample Receiver single use, disposable containing the elution buffer ●
- Test Base single use, disposable comprising two sealed reaction tubes, each containing a lyophilized ● pellet
- . Transfer Cartridge – Single use, disposable for transfer of the eluted sample to the Test Base, and
- Alere™ i Instrument - repeat use reader
The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B, which occur in two separate reaction tube contains fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets. Alere™ i Influenza A & B 2 is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.
To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, re-suspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating, mixing and detection by fluorescence are provided by the instrument, with results automatically reported.
Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.
INTENDED USE
The Alere™ i Influenza A & B 2 assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2016-2017 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
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 department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
5
TECHNICAL CHARACTERISTICS
Alere™ i Influenza A & B 2 and the predicate device, Alere™ i Influenza A & B, have the same intended use, indications for use, and utilize similar basic principles of operation. They are both molecular tests for the qualitative detection of influenza A and influenza B viral RNA.
DEVICE COMPARISON
Alere™ i Influenza A & B 2 was compared to the legally marketed predicate device, the Alere™ i Influenza A & B Assay.
| Parameter | Alere™ i Influenza A & B 2 | Alere™ i Influenza A & B
(K163266) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product Code | OCC, OZE, OOI | Same |
| Assay Target | Influenza A, Influenza B | Same |
| Intended Use | The Alere™ i Influenza A & B 2 assay performed
on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic
acid amplification technology for the qualitative
detection and discrimination of influenza A and B
viral RNA in direct nasal or nasopharyngeal
swabs and nasal or nasopharyngeal swabs
eluted in viral transport media from patients with
signs and symptoms of respiratory infection. It is
intended for use as an aid in the differential
diagnosis of influenza A and B viral infections in
humans in conjunction with clinical and
epidemiological risk factors. The assay is not
intended to detect the presence of influenza C
virus. | The Alere™ i Influenza A & B assay performed
on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal
nucleic acid amplification technology for the
qualitative detection and discrimination of
influenza A and B viral RNA in direct nasal
swabs and nasal or nasopharyngeal swabs
eluted in viral transport media from patients
with signs and symptoms of respiratory
infection. It is intended for use as an aid in the
differential diagnosis of influenza A and B viral
infections in humans in conjunction with clinical
and epidemiological risk factors. The assay is
not intended to detect the presence of
influenza C virus. |
| | Negative results do not preclude influenza virus
infection and should not be used as the sole
basis for diagnosis, treatment or other patient
management decisions. | Negative results do not preclude influenza virus
infection and should not be used as the sole
basis for diagnosis, treatment or other patient
management decisions. |
| | Performance characteristics for influenza A were
established during the 2016-2017 influenza
season when influenza A/H3 and A/H1N1
pandemic were the predominant influenza A
viruses in circulation. When other influenza A
viruses are emerging, performance
characteristics may vary. | Performance characteristics for influenza A
were established during the 2012-2013 and the
2014-2015 influenza seasons when influenza
A/H3 and A/H1N1 pandemic were the
predominant influenza A viruses in circulation.
When other influenza A viruses are emerging,
performance characteristics may vary. |
| | 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 department for
testing. Viral culture should not be attempted in
these cases unless a BSL 3+ facility is available
to receive and culture specimens. | 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 department for testing. Viral culture
should not be attempted in these cases unless
a BSL 3+ facility is available to receive and
culture specimens. |
| 2Intended Environment
for Use | Professional use, in a medical laboratory or point-of-care | Same |
| Instrumentation | Alere™ i Instrument | Same |
| Self-Contained System | Integrated PC, Software and Touch Screen
Display | Same |
| Automated Assay | Yes. Sample preparation, amplification, detection, and result interpretation. | Same |
| Assay Information | | |
| Sample Type | Nasopharyngeal Swab, Nasopharyngeal Swab | Nasal Swab, Nasal Swab or Nasopharyngeal |
| Parameter | Alere™ i Influenza A & B 2 | Alere™ i Influenza A & B
(K163266) |
| | eluted in Viral Transport Media, Nasal Swab,
Nasal Swab eluted in Viral Transport Media | Swab eluted in Viral Transport Media |
| Influenza A Target | PB2 Segment | Same |
| Influenza B Target | PA Segment | Same |
| Technology | Isothermal nucleic acid amplification for detecting
the presence/absence of viral RNA in clinical
specimens. | Same |
| Internal Control | Yes | Same |
| Results Interpretation | Automated | Same |
| Assay Result | Qualitative | Same |
| Time to Result | Bacteria | Viruses |
|---------------------------|--------------------|
| Bordetella bronchiseptica | Adenovirus 2 |
| Chlamydia pneumoniae | Adenovirus 3 |
| Chlamydia trachomatis | Adenovirus 4 |
| Neisseria gonorrhoae | Adenovirus 5 |
| Neisseria mucosa | Adenovirus 11 |
| Proteus mirabilis | Adenovirus 14 |
| | Adenovirus 31 |
| | Coronavirus NL63 |
| | Coxsackievirus B35 |
| | Echovirus 6 |
| | Echovirus 9 |
| | Echovirus 11 |
10
Enterovirus 71
INTERFERING SUBSTANCES
The following substances, naturally present or artificially introduced into the nasal cavity or nasopharynx were evaluated with Alere™ i Influenza A & B 2 at the concentrations listed below and were found not to affect test performance.
| Substance | Concentration |
|---|---|
| Mucin | 0.5% w/v |
| Whole Blood | 1% v/v |
| NeoSynephrine Nasal Spray | 20% v/v |
| Afrin Original Nasal Spray | 20% v/v |
| Ocean Saline Nasal Spray | 20% v/v |
| Chloroseptic Max | 20% w/v |
| Zicam | 20% v/v |
| Beclomethasone | 0.068 mg/mL |
| Budesonide | 0.051 mg/mL |
| Dexamethasone | 0.48 mg/mL |
| Flunisolide | 0.04 mg/mL |
| Fluticasone | 0.04 mg/mL |
| Mometasone | 0.04 mg/mL |
| Mupirocin | 4.3 mg/mL |
| Tobryamycin | 1.44 mg/mL |
| Triamcinolone | 0.04 mg/mL |
| Zanamivir (Relenza) | 0.284 mg/mL |
Inhibition by other Microorganisms
Alere™ i Influenza A & B test performance in the presence of non-influenza respiratory pathogens was evaluated. Vendor provided stocks of influenza A and B strains were diluted in UTM to approximately 3 times the limit of detection. Contrived influenza A and B positive swab specimens were prepared by coating 10 virus dilution onto each swab. The following panel of non-influenza viruses were tested at the concentration provided in the table below and was found not to affect test performance.
| Virus Panel | Concentration |
|---|---|
| Adenovirus Type 1 | 2.95 x 107 TCID50/mL |
| Rhinovirus Type 1A | 1.58 x 108 TCID50/mL |
| Respiratory Syncytial Virus, Type B, Strain 18537 | 3.00 x 103 (PFU/mL) |
Inhibition by High Levels of Influenza A and B
Alere™ i Influenza A & B test performance in the presence of influenza A and B was evaluated. Vendor provided stocks of influenza A and B strains were diluted in UTM to approximately 3 times the limit of detection. Contrived influenza A and B positive swab specimens were prepared by coating 10 microliters of virus dilution onto each swab. To create the co-infection swabs, diluted influenza A (at a concentration approximately 30 times the LoD) was added to the near LoD Flu B swab. Likewise, diluted influenza B (at a concentration approximately 30 times the LoD) was added to the near LoD Flu A swab. No impact on test performance was observed.
Carry-Over Contamination
An analytical carry-over study was performed to demonstrate that when recommended laboratory practices are followed, there is little risk of false positive results caused by carryover or cross-contamination in the Alere™ i Influenza A & B 2 test. Vendor provided stocks of influenza A and B strains were diluted in UTM to approximately 30 times the limit of detection. Contrived influenza A and B positive swab specimens were prepared by coating 10
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microliters of virus dilution onto each swab. Testing of the contrived positive swabs was alternated with testing of a negative swab sample for a total of 15 rounds. There were no false positive results obtained.
An additional analytical carry-over study was performed testive VTM samples alternated with negative VTM samples following the test procedure for Nasal or Nasopharyngeal Swab Eluted in Viral Transport Media for a total of 15 rounds. There were no false positive results obtained.
REPRODUCIBILITY
A reproducibility study of Alere™ i Influenza A & B 2 was conducted by operators from 3 sites using panels of blind coded specimens containing negative (at the limit of detection), and moderate positive (above the limit of detection) influenza A and B samples. Participants tested each sample multiple times on 5 different days. The percent agreement with expected results for the influenza A moderate positive samples was 100% (90/90). The percent agreement with expected result for the influenza B moderate positive and low positive samples were 100% (89/89), 98.9% (89/90), respectfully. All of the true negative samples (89) generated negative test results. There were no significant differences observed within run (replicates tested by one operator), between run (five different days), between sites (three sites), or between operators (nine operators).