(28 days)
Not Found
No
The device description and performance studies focus on rRT-PCR technology for nucleic acid detection, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) test kit used for the qualitative detection of influenza A and B viral nucleic acids. It provides diagnostic information but does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that the device is for "in vitro qualitative detection of influenza A and influenza B viral nucleic acids" and that "Test results are to be used in conjunction with other clinical and epidemiological information," which are characteristics of a diagnostic device.
No
The device is a test kit containing reagents (rRT-PCR assays) for detecting viral nucleic acids, which is a physical component, not solely software. It is used with a JBAIDS instrument and software, but the kit itself is not software.
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 kit is for the "in vitro qualitative detection of influenza A and influenza B viral nucleic acids isolated and purified nasopharygeal swab (NPS) and nasopharygeal wash (NPW) specimens from human patients". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The "Device Description" further clarifies that it's a "rRT-PCR test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of influenza A and B viral RNA." Again, the term "in vitro" is used.
- Specimen Type: The device analyzes human specimens (nasopharyngeal swabs and washes) to provide information about a patient's health status (presence of influenza A and B viral nucleic acids). This is a core function of IVDs.
- Diagnostic Purpose: The results are intended to be used in conjunction with other clinical and epidemiological information to aid in the diagnosis of influenza.
Therefore, based on the provided text, the JBAIDS Influenza A & B Detection Kit clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of influenza A and influenza B viral nucleic acids isolated and purified nasopharygeal swab (NPS) and nasopharygeal wash (NPW) specimens from human patients with signs and symptoms of respiratory infection.
The JBAIDS Influenza A & B Detection Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays that target the Matrix protein gene of influenza A viruses, and the Non-structural protein gene of influenza B viruses. This kit is not intended to detect influenza C viruses.
Test results are to be used in conjunction with other clinical and epidemiological information. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for detection of influenza A were established when 2009 H1N1 Influenza, Influenza A H1N1, and Influenza A H3N2 were the predominant influenza A viruses in circulation. Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H1 were established primarily with retrospective and surrogate clinical specimens. When other influenza A viruses are present, performance characteristics may vary.
All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.
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 biosafety (BSL) 3+ facility is available to receive and culture specimens.
Product codes
OCC
Device Description
The JBAIDS Influenza A & B Detection Kit is a rRT-PCR test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of influenza A and B viral RNA. These two assays have been optimized as freeze-dried assays with primer and fluorescent-probe sets for the detection of influenza A and B viral RNA. In particular, the influenza A assay targets a region of the matrix gene specific to the influenza A virus genera, and the influenza B assay targets a region of the nonstructural gene specific to the influenza B virus genera. The tests are performed using the previously FDA-cleared JBAIDS instrument and software. A human gene target assay (RNAse P target) will be used as an inhibition and extraction control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharygeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.
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
Not Found
Summary of Performance Studies
The estimated analytical sensitivity or Limit of Detection (LoD) was determined for four strains of A H3N2 (two seasonal A H3N2 strains, and two swine variant, or A H3N2v, strains) and one strain of H7N9 using the Flu A assay. Simulated nasopharyngeal swab samples were extracted using the IT 1-2-3TM Platinum Path Sample Purification Kit prior to testing with the JBAIDS Influenza A & B Detection kit. Serial dilutions were run in triplicate, with all three replicates required to read positive in order for that dilution to be called positive.
Estimation studies suggested that the LOD for H7N9 was 4 x 104 EID50 /mL. Upon refinement and running further replicates, the confirmed LOD for H7N9 was determined to be 4 x 10 EIDs0 /mL. LOD estimation studies suggested that the LOD for H3N2v was between 2 and 32 TCID-0 /mL.
Key Metrics
LoD for H7N9: 4 x 10 EIDs0 /mL.
LoD for H3N2v: between 2 and 32 TCID-0 /mL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three overlapping lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2015
U.S. Army Medical Materiel Development Activity Robert Miller, PhD, RAC Director, Division of Regulated Activities and Compliance 1430 Veterans Drive Fort Detrick, MD 21702-9232
Re: K152523
Trade/Device Name: JBAIDS Influenza A & B Detection Kit Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC Dated: September 2, 2015 Received: September 3, 2015
Dear Dr. Miller:
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 (QS) 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,
Tamara V. Feldblyum -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) K152523
Device Name JBAIDS Influenza A & B Detection Kit
Indications for Use (Describe)
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of influenza B viral nucleic acids isolated and purified NPS and NPW specimens from human patients with signs and symptoms of respiratory infection.
The JBAIDS Influenza A & B Detection Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays that target the Matrix protein gene of influenza A viruses, and the Non-structural protein gene of influenza B viruses. This kit is not intended to detect influenza C viruses.
Test results are to be used in conjunction with other clinical and epidemiological information. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for detection of influenza A were established when 2009 H1N1 Influenza, Influenza A H1N1, and Influenza A H3N2 were the predominant influenza A viruses in circulation. Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H1 were established primarily with retrospective and surrogate clinical specimens. When other influenza A viruses are present, performance characteristics may vary. All users, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.
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 biosatory (BSL) 3+ facility is available to receive and culture specimens.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
|---|---|
| The burden time for this collection of information is estimated to average 79 hours per response, including the | |
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | |
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | |
| of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of |
information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle in the center with its wings spread. The eagle is holding arrows and an olive branch. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written around the top of the circle, and the words "UNITED STATES OF AMERICA" are written around the bottom of the circle.
DEPARTMENT OF THE A U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-5009
510(k) Summary
1. Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 2.
| Administrative Information | |
|---|---|
| Submitted by: | The Surgeon General, Department of the Army |
| Primary Contact: | Robert Miller, PhD, RAC |
| Director, Division of Regulated Activities and Compliance | |
| Telephone: 301-619-0317 | |
| Fax: 301-619-0197 | |
| Email: usarmy.detrick.medcom-usammda.mbx.usamrmc- | |
| regulatory-affairs@mail.mil | |
| Secondary Contact: | Chandar Thakur, PhD, RAC |
| Regulatory Affairs Scientist, Division of Regulated Activities and | |
| Compliance | |
| Telephone: 301-619-2979 | |
| Fax: 301-619-0197 | |
| Email: chandar.s.thakur.ctr@mail.mil or usarmy.detrick.medcom- | |
| usammda.mbx.usamrmc-regulatory-affairs@mail.mil | |
| Technical Contact: | Cynthia Phillips, PhD |
| Director, Regulated Products, BioFire Defense, LLC | |
| Telephone:801-262-3592, ext 1370 | |
| Fax: 801-447-6907 | |
| Email: cynthia.phillips@biofiredefense.com | |
| 3. | |
| Device | |
| Device Name/ Trade Name: | JBAIDS Influenza A & B Detection Kit |
| Common Name: | Real-time PCR assay for detection of Influenza A and Influenza B |
| Classification Name: | Respiratory viral panel multiplex nucleic acid assay (21 CFR |
| 866.3980) |
4
Image /page/4/Picture/0 description: The image is the seal of the Department of Defense. The seal is circular and contains an eagle with its wings spread, holding arrows and an olive branch. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written around the top of the seal, and "UNITED STATES OF AMERICA" are written around the bottom.
DEPARTMENT OF THE AR U.S. ARMY MEDICAL MATERIEL DEVELOPMENT 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-500
4. Intended Use
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of influenza A and influenza B viral nucleic acids isolated and purified nasopharygeal swab (NPS) and nasopharygeal wash (NPW) specimens from human patients with signs and symptoms of respiratory infection.
The JBAIDS Influenza A & B Detection Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays that target the Matrix protein gene of influenza A viruses, and the Non-structural protein gene of influenza B viruses. This kit is not intended to detect influenza C viruses.
Test results are to be used in conjunction with other clinical and epidemiological information. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for detection of influenza A were established when 2009 H1N1 Influenza, Influenza A H1N1, and Influenza A H3N2 were the predominant influenza A viruses in circulation. Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H1 were established primarily with retrospective and surrogate clinical specimens. When other influenza A viruses are present, performance characteristics may vary.
All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.
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 biosafety (BSL) 3+ facility is available to receive and culture specimens.
5. Device Description
The JBAIDS Influenza A & B Detection Kit is a rRT-PCR test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of influenza A and B viral RNA. These two assays have been optimized as freeze-dried assays with primer and fluorescent-probe sets for the detection of influenza A and B viral RNA. In particular, the influenza A assay targets a region of the matrix gene specific to the influenza A virus genera, and the influenza B assay targets a region of the nonstructural gene specific to the influenza B virus genera. The tests are performed using the previously FDA-cleared JBAIDS instrument and software. A human gene target assay (RNAse P target) will be used as an inhibition and extraction control.
5
Image /page/5/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle with its wings spread, clutching arrows and an olive branch. Above the eagle are 13 stars arranged in an arc. The words "DEPARTMENT OF DEFENSE" are written around the top of the circle, and "UNITED STATES OF AMERICA" is written around the bottom.
DEPARTMENT OF THE AR U.S. ARMY MEDICAL MATERIEL DEVELOPMENT 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-5009
6. Assay Principle
Before testing, NPS or NPW specimens are purified using Idaho Technology's 1-2-3TM Platinum Path Sample Purification Kit or the Roche MagNA Pure Compact Nucleic Acid Isolation Kit I. The resulting purified sample is added to unknown reagent vials and a sample control reagent vial, along with reconstitution buffer. When viral RNA is present, a fragment of influenza A or B viral RNA is transcribed and amplified. The amplicon is detected by fluorescence using a specific hydrolysis probe. Each probe is labeled on one end with a fluorescent reporter moiety (6-carboxyfluorescein (6-FAM)) and elsewhere with a quencher moiety (carboxy tetramethylrhodamine (TAMRA)). When the probe is intact, the quencher absorbs the light emitted by the reporter moiety. During PCR, the probe hybridizes to the target sequence before the exonuclease activity of Taq polymerase hydrolyzes the probe, separating the fluorophore from the quencher and permitting detection of the fluorescent signal generated by the reporter. The fluorescent signal increases as additional templates are amplified and more probes are hydrolyzed. JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, or uncertain. A failure of the positive control will result in the entire run being called invalid. Failure of the sample control vields a result of "sample control failure" when the associated sample has a negative result for the target assay. Retesting is required to resolve uncertain, invalid, or sample control failure results.
7. Substantial Equivalence
The modified JBAIDS Influenza A & B Detection System is substantially equivalent to the current legally marketed device. JBAIDS Influenza A & B Detection Kit. Additions made to the labeling to add additional strain testing did not change the intended use of the device or the fundamental scientific technology.
The JBAIDS Influenza A & B Detection Kit with additional labeling for detection of Influenza A H3N2v and H7N9 strains described is substantially equivalent to the JBAIDS Influenza A & B Detection Kit, which was cleared on September 13, 2011 under 510(k) K111775.
6
Image /page/6/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle with its wings spread, holding arrows and an olive branch. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written around the top of the circle, and "UNITED STATES OF AMERICA" are written around the bottom.
DEPARTMENT OF THE ARN U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-5009
Table 1: Similarities Between the JBAIDS Influenza A & B Detection Kit (this submission) and the JBAIDS Influenza A & B Detection Kit (K111775)
| Element | JBAIDS Influenza A and B Detection kit
(this submission) | JBAIDS Influenza A and B
Detection kit (K111775) |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Technology | Real time PCR using hydrolysis probes | Same |
| Viruses Detected | Qualitative in vitro detection of Influenza
A and Influenza B virus nucleic acids | Same (see Table 2) |
| Specimen Types | Nasopharyngeal swabs and
Nasopharyngeal washes | Same (see Table 2) |
| Extraction Methods | IT 1-2-3TM Platinum Path Sample
Purification Kit and Roche MagNA Pure
Compact Nucleic Acid Isolation
Kit I | Same (see Table 2) |
| Required Instrumentation | JBAIDS Instrument | Same |
| Interpretation of Test
Results | Automated analysis of test results and
controls | Same |
| Reagent Storage | Reagents are stored at room temperature | Same |
Table 2: Differences Between the JBAIDS Influenza A & B Detection Kit (this submission) and the JBAIDS Influenza A & B Detection Kit (K111775)
| Element | JBAIDS Influenza A and B Detection kit
(this submission) | JBAIDS Influenza A and B
Detection kit (K111775) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Organisms Detected | Demonstrated inclusive detection of
Influenza A H3N2v and A H7N9 as
positive for Influenza A | Not labeled for detection of
Influenza A H3N2v and H7N9. |
| Specimen Types | Demonstrated detection of A H3N2v and A
H7N9 from simulated nasopharyngeal
swabs. No testing of these strains has been
performed on nasopharyngeal washes. | Nasopharyngeal swabs and
washes |
| Extraction methods | Demonstrated detection of Influenza A
H3N2v and A H7N9 from simulated
nasopharyngeal swab samples extracted
using the IT 1-2-3TM Platinum Path Sample
Purification Kit. No testing of these strains
was performed on samples extracted using
the Roche MagNA Pure Compact Nucleic
Acid Isolation Kit. | IT 1-2-3TM Platinum Path Sample
Purification Kit and Roche MagNA
Pure Compact Nucleic Acid
Isolation Kit |
8. Selected Analytical Studies
The estimated analytical sensitivity or Limit of Detection (LoD) was determined for four strains of A H3N2 (two seasonal A H3N2 strains, and two swine variant, or A H3N2v, strains) and one strain of H7N9 using the Flu A assay. Simulated nasopharyngeal swab samples were extracted using the IT 1-2-3™ Platinum Path Sample Purification Kit prior to testing with the JBAIDS
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Image /page/7/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle with outstretched wings in the center. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written around the top of the circle, and "UNITED STATES OF AMERICA" are written around the bottom.
DEPARTMENT OF THE A U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-5009
Influenza A & B Detection kit. Serial dilutions were run in triplicate, with all three replicates required to read positive in order for that dilution to be called positive. Results are shown in Table 3 and Table 4. This data was added to the analytical inclusivity section of the package insert.
Estimation studies suggested that the LOD for H7N9 was 4 x 104 EID50 /mL. Upon refinement and running further replicates, the confirmed LOD for H7N9 was determined to be 4 x 10 EIDs0 /mL. LOD estimation studies suggested that the LOD for H3N2v was between 2 and 32 TCID-0 /mL.
| Strain | Concentration | No. Positive
Replicates |
|----------------|--------------------|----------------------------|
| A/Anhui/1/2013 | 8.0 x 105 EID50/ml | 3/3 |
| A/Anhui/1/2013 | 4.0 x 105 EID50/ml | 3/3 |
| A/Anhui/1/2013 | 8.0 x 104 EID50/ml | 3/3 |
| A/Anhui/1/2013 | 4.0 x 104 EID50/ml | 3/3 |
| A/Anhui/1/2013 | 8.0 x 103 EID50/ml | 2/3 |
| A/Anhui/1/2013 | 4.0 x 103 EID50/ml | 2/3 |
| A/Anhui/1/2013 | 8.0 x 102 EID50/ml | 1/3 |
| A/Anhui/1/2013 | 4.0 x 102 EID50/ml | 0/3 |
| A/Anhui/1/2013 | 8.0 x 101 EID50/ml | 2/3 |
| A/Anhui/1/2013 | 4.0 x 101 EID50/ml | 0/3 |
Table 3: Estimated LoD of H7N9 (A/Anhui/1/2013)
Estimated LoD of H3N2 and H3N2v Strains Table 4:
| Strain | Isolate | LoD (TCID50/mL) |
|---|---|---|
| Influenza A H3N2 (seasonal) | A/Victoria/361/2011 | 63.0 |
| Influenza A H3N2 (seasonal) | A/Perth/16/2009 | 6.3 |
| Influenza A swine variant H3N2v | A/West/Virginia/06/2011 | 31.6 |
| Influenza A swine variant H3N2v | A/Minnesota/11/2010 | 2.0 |
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Image /page/8/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle holding arrows and an olive branch. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written along the top of the circle, and "UNITED STATES OF AMERICA" are written along the bottom.
9. References
Centers for Disease Control and Prevention. Influenza A (H3N2) Variant Virus. Accessed: 26 Aug 2015: Available from: http://www.cdc.gov/flu/swineflu/h3n2v-cases.htm.
Clinical and Laboratory Standards Institute. Protocols for Determination of Limits of Detection and Limits of Quantitation. CLSI Approved Guidance EP17-A (2004).
Clinical and Laboratory Standards Institute. Evaluation of Precision Performance of Quantitative Measurements Methods; Approved Guidance-Second Edition, CLSI Approved Guidance EP5-A2 (August 2004).
United States Food and Drug Administration. In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path, Guidance for Industry and FDA Staff (May 1, 2007).