(22 days)
Not Found
No
The device description details a standard RT-PCR assay with real-time fluorescence monitoring. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision-making. The results are based on the detection of fluorescent signals generated by the chemical reaction.
No
The ProFAST™+ Assay is an in vitro diagnostic test designed for the qualitative detection and discrimination of specific influenza viral nucleic acids, making it a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The ProFAST™+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/H1, seasonal Influenza A/H3 and 2009 H1N1 Influenza viral nucleic acids..." This directly indicates its purpose in diagnosing influenza.
No
The device description clearly outlines a multi-step process involving physical specimens, reagents, and laboratory instruments (MagNA Pure LC Instrument, NucliSENS easyMAG System, Cepheid SmartCycler II instrument) for nucleic acid isolation, purification, and amplification. This indicates a hardware-dependent in vitro diagnostic test, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ProFAST™+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/H1, seasonal Influenza A/H3 and 2009 H1N1 Influenza viral nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ProFAST™+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/H1, seasonal Influenza A/H3 and 2009 H1N1 Influenza viral nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay targets conserved regions of the Hemagglutinin (HA) gene for seasonal Influenza A/H1. seasonal Influenza A/H3 and 2009 H1N1 Influenza Virus, respectively. This assay is not intended to detect Influenza B or Influenza C Viruses.
A negative ProFAST+ Assay result is a presumptive negative result for Influenza A. These results should be confirmed by an FDA cleared nucleic acid-based test (NAT) detecting Influenza A.
Negative results do not preclude Influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
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)
OQW
Device Description
The ProFAST+ Assay enables detection and discrimination of Influenza A Virus subtypes: seasonal H1, seasonal H3, and 2009 H1N1.
An overview of the procedure is as follows:
- Collect nasopharyngeal swab specimens from symptomatic patients using a polyester, ravon, or nylon tipped swab and place into viral transport medium (refer to Materials Required but not Provided section of this Instruction for Use).
- Add an Internal Control (IC) to every sample to monitor for inhibitors present in the specimens.
- Perform isolation and purification of nucleic acids using a MagNA Pure LC Instrument (Roche) and the MagNA Pure Total Nucleic Acid Isolation Kit (Roche) or a NucliSENS easyMAG System (bioMérieux) and the Automated Magnetic Extraction Reagents (bioMérieux).
- Add purified nucleic acids to the ProFAST+ Supermix along with enzymes included in the ProFAST+ kit. The ProFAST+ Supermix contains target-specific oligonucleotide primers and probes. The primers are complementary to conserved regions of the Hemagglutinin (HA) gene for seasonal influenza A/H1, seasonal influenza A/H3 and 2009 H1N1 Influenza Virus (swine-origin), respectively. The probes are dual-labeled with a reporter dye and a quencher dye (see table below).
- Perform reverse transcription of RNA into complementary DNA (cDNA) and subsequent amplification of DNA in a Cepheid SmartCycler II instrument. In this process, the probe anneals specifically to the template followed by primer extension and amplification. The ProFAST+ Assay is based on Taqman chemistry, which utilizes the 5' - 3' exonuclease activity of the Taq polymerase to cleave the probe thus separating the reporter dye from the quencher. This generates an increase in fluorescent signal upon excitation from a light source. With each cycle, additional reporter dye molecules are cleaved from their respective probes, further increasing fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification products present at that time. Fluorescent intensity is monitored during each PCR cycle by the real-time instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal (NP) swab specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Prospective Study:
- Sample Size: A total of 874 prospective NP swab specimens were initially included. After exclusion, 842 eligible prospective specimens were included in the data analysis.
- Data Source: NP swab samples collected and tested at three U.S. clinical laboratories during December 2009 thru May 2010. Prospectively collected archived samples from January - March, 2008, February - March, 2009 and October - November, 2009, tested at two U.S. clinical laboratories. Specimens were excess remnants from symptomatic individuals suspected of respiratory infection, submitted for routine care or analysis.
- Annotation Protocol: Performance was assessed and compared to a composite comparator/reference method of the FDA cleared ProFlu+ Assay and individual well characterized Influenza A subtype specific RT-PCR assays followed by bi-directional sequencing. "True" positives were samples positive by ProFlu+ Assay and had bidirectional sequencing data meeting quality criteria that matched NCBI GenBank sequences for the specific subtype with acceptable E-values. "True" negatives were samples negative by ProFlu+ Assay IVD, or positive by ProFlu+ Assay IVD but negative by respective Influenza A subtype specific RT-PCR assay followed by bi-directional sequencing. Nucleic acid extractions were carried out using either the Roche MagNA Pure LC system or the bioMérieux NucliSENS easyMAG.
Retrospective Study:
- Sample Size: A total of 160 retrospective nasopharyngeal (NP) swab samples.
- Data Source: Retrospective samples collected from January - March, 2008, January - November 2009, and March 2010 at two clinical sites.
- Annotation Protocol: The ProFAST+ Assay was compared to the same composite comparator/reference method as the prospective study (FDA cleared ProFlu+ Assay and individual well characterized Influenza A subtype specific RT-PCR assays followed by bi-directional sequencing).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Performance Studies (Prospective and Retrospective) and Reproducibility Study.
Prospective Clinical Performance:
- Sample Size: 842 eligible prospective NP swab specimens.
- Key Results (Percent Agreement with ProFlu+/Sequencing Comparator):
- Seasonal Influenza A/H1:
- Positive Percent Agreement = 100.0% (93.2% - 100.0%) 95% CI (61/61)
- Negative Percent Agreement = 99.0% (98.0% - 99.5%) 95% CI (781/789)
- Seasonal Influenza A/H3:
- Positive Percent Agreement = 100.0% (86.7% - 100.0%) 95% CI (25/25)
- Negative Percent Agreement = 99.6% (98.9% - 99.9%) 95% CI (814/817)
- 2009 H1N1 Influenza A:
- Positive Percent Agreement = 95.4% (87.3% - 98.4%) 95% CI (62/65)
- Negative Percent Agreement = 100.0% (99.5% - 100.0%) 95% CI (777/777)
- Seasonal Influenza A/H1:
- Other: 98.9% (864/874) of specimens were successful on first attempt.
Retrospective Clinical Performance:
- Sample Size: 160 retrospective NP swab samples.
- Key Results (Percent Agreement with ProFlu+/Sequencing Comparator):
- Seasonal Influenza A/H1:
- Positive Percent Agreement = 94.4% (74.3% - 99.0%) 95% CI (17/18)
- Negative Percent Agreement = 99.3% (96.1% - 99.9%) 95% CI (141/142)
- Seasonal Influenza A/H3:
- Positive Percent Agreement = 100.0% (94.9% - 100.0%) 95% CI (72/72)
- Negative Percent Agreement = 100.0% (95.8% - 100.0%) 95% CI (88/88)
- 2009 H1N1 Influenza A:
- Positive Percent Agreement = 100.0% (86.7% - 100.0%) 95% CI (25/25)
- Negative Percent Agreement = 100.0% (97.2% - 100.0%) 95% CI (135/135)
- Seasonal Influenza A/H1:
Reproducibility Study:
- Study Type: Multi-site reproducibility study.
- Sample Size: Panel of 18 simulated samples (medium positive, low positive, high negative for each of the three Influenza A subtypes). Tested at 3 laboratory sites, 2 operators per site, for 5 days.
- Key Results: The overall percent agreement with the expected result for the ProFAST+ Assay was 99.7%.
- Site 1: 210/210 (100%) agreement
- Site 2: 210/210 (100%) agreement
- Site 3: 208/210 (99.0%) agreement
- Total Agreement with Expected Result: 628/630 (99.7%)
- 95% CI: 98.8% - 99.9%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Study - Percent Agreement to Comparator Method:
- Seasonal Influenza A/H1: Positive Percent Agreement=100.0%, Negative Percent Agreement=99.0%
- Seasonal Influenza A/H3: Positive Percent Agreement=100.0%, Negative Percent Agreement=99.6%
- 2009 H1N1 Influenza A: Positive Percent Agreement=95.4%, Negative Percent Agreement=100.0%
Retrospective Study - Percent Agreement to Comparator Method:
- Seasonal Influenza A/H1: Positive Percent Agreement=94.4%, Negative Percent Agreement=99.3%
- Seasonal Influenza A/H3: Positive Percent Agreement=100.0%, Negative Percent Agreement=100.0%
- 2009 H1N1 Influenza A: Positive Percent Agreement=100.0%, Negative Percent Agreement=100.0%
Reproducibility: Overall Percent Agreement with Expected Result = 99.7%
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.
K063765, K081483, K091677, K080570, K100148, K073029, K081030, K092500
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
§ 866.3332 Reagents for detection of specific novel influenza A viruses.
(a)
Identification. Reagents for detection of specific novel influenza A viruses are devices that are intended for use in a nucleic acid amplification test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Detection of specific virus RNA aids in the diagnosis of influenza caused by specific novel influenza A viruses in patients with clinical risk of infection with these viruses, and also aids in the presumptive laboratory identification of specific novel influenza A viruses to provide epidemiological information on influenza. These reagents include primers, probes, and specific influenza A virus controls.(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses.” See § 866.1(e) for information on obtaining this document.
(2) The distribution of these devices is limited to laboratories with experienced personnel who have training in standardized molecular testing procedures and expertise in viral diagnosis, and appropriate biosafety equipment and containment.
0
Page 1 of 7 Date: July 21, 2010
Attachment D 510(k) SUMMARY
CONTACT
Karen Harrington Gen-Probe Prodesse, Inc. W229 N1870 Westwood Dr. Waukesha, WI 53186
JUL 2 3 2010
NAME OF DEVICE
| Trade Name: |
|---|
| Regulation Number: |
| Classification Name: |
ProFAST+TM Assay 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay
PREDICATE DEVICE
- K063765, K081483, K091677 ID Tag Respiratory Virus Panel, Luminex Molecular . Diagnostics
- K080570 Human Influenza Virus Real Time RT-PCR Detection and Characterization . Panel. CDC
- K100148 Simplexa Influenza A H1N1 (2009), Focus Diagnostics .
- . K073029. K081030. K092500 - ProFlu+ Assav. Gen-Probe Prodesse, Inc.
INTENDED USE
The ProFAST™+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/H1, seasonal Influenza A/H3 and 2009 H1N1 Influenza viral nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This assay targets conserved regions of the Hemagglutinin (HA) gene for seasonal Influenza A/H1, seasonal Influenza A/H3 and 2009 H1N1 Influenza Virus, respectively. This assay is not intended to detect Influenza B or Influenza C Viruses.
A negative ProFAST+ Assay result is a presumptive negative result for Influenza A. These results should be confirmed by an FDA cleared nucleic acid-based test (NAT) detecting Influenza A.
Negative results do not preclude Influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
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.
1
PRODUCT DESCRIPTION
The ProFAST+ Assay enables detection and discrimination of Influenza A Virus subtypes: seasonal H1, seasonal H3, and 2009 H1N1.
An overview of the procedure is as follows:
-
- Collect nasopharyngeal swab specimens from symptomatic patients using a polyester, ravon, or nylon tipped swab and place into viral transport medium (refer to Materials Required but not Provided section of this Instruction for Use).
-
- Add an Internal Control (IC) to every sample to monitor for inhibitors present in the specimens.
-
- Perform isolation and purification of nucleic acids using a MagNA Pure LC Instrument (Roche) and the MagNA Pure Total Nucleic Acid Isolation Kit (Roche) or a NucliSENS easyMAG System (bioMérieux) and the Automated Magnetic Extraction Reagents (bioMérieux).
-
- Add purified nucleic acids to the ProFAST+ Supermix along with enzymes included in the ProFAST+ kit. The ProFAST+ Supermix contains target-specific oligonucleotide primers and probes. The primers are complementary to conserved regions of the Hemagglutinin (HA) gene for seasonal influenza A/H1, seasonal influenza A/H3 and 2009 H1N1 Influenza Virus (swine-origin), respectively. The probes are dual-labeled with a reporter dye and a quencher dye (see table below).
-
- Perform reverse transcription of RNA into complementary DNA (cDNA) and subsequent amplification of DNA in a Cepheid SmartCycler II instrument. In this process, the probe anneals specifically to the template followed by primer extension and amplification. The ProFAST+ Assay is based on Taqman chemistry, which utilizes the 5' - 3' exonuclease activity of the Taq polymerase to cleave the probe thus separating the reporter dye from the quencher. This generates an increase in fluorescent signal upon excitation from a light source. With each cycle, additional reporter dye molecules are cleaved from their respective probes, further increasing fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification products present at that time. Fluorescent intensity is monitored during each PCR cycle by the real-time instrument.
| Analyte | Gene Targeted | Probe Fluorophore | Absorbance
Peak | Emission
Peak |
|---------------------------|----------------------------|----------------------|--------------------|------------------|
| Seasonal H1 Influenza A | Hemagglutinin | FAM | 495 nm | 520 nm |
| Seasonal H3 Influenza A | Hemagglutinin | Cal Fluor Orange 560 | 540 nm | 561 nm |
| 2009 H1N1 Influenza Virus | Hemagglutinin | Cal Fluor Red 610 | 595 nm | 615 nm |
| Internal Control | E.coli MS2 Phage A-Protein | Quasar 670 | 647 nm | 667 nm |
2
SUBSTANTIAL EQUIVALENCE
Clinical Performance
The clinical performance of the ProFAST+ Assay was established during prospective studies at 4 U.S. clinical laboratories. NP swab samples were collected and tested at three U.S. clinical laboratories during December 2009 thru May 2010. Due to the absence of seasonal (HINI or H3N2) and 2009 H1N1 Influenza A during the typical 2009-2010 winter season, prospectively collected archived samples were also included in the prospective studies. These samples were collected from January - March, 2008, February - March, 2009 and October - November, 2009, and tested at two U.S. clinical laboratories. All specimens used in the study meeting the inclusion and exclusion criteria represented excess, remnants of nasopharyngeal (NP) swab specimens that were prospectively collected from symptomatic individuals suspected of respiratory infection, and were submitted for routine care or analysis by each site, and that otherwise would have been discarded.
Demographic details for the patient population included in the prospective study are summarized in the following table.
| Sex | Number of Subjects |
|---|---|
| Female | 439 (52.1%) |
| Male | 403 (47.9%) |
| Age | |
| ≤ 5 years | 439 (52.1%) |
| 6 - 21 years | 184 (21.9%) |
| 22 - 59 years | 168 (20.0%) |
| ≥ 60 years | 51 (6.0%) |
Gender and Age Demographic Detail for ProFAST+ Prospective Study
Performance of the ProFAST+ Assay was assessed and compared to the composite comparator/reference method of the FDA cleared ProFlu+ Assay and individual well characterized Influenza A subtype specific RT-PCR assays followed by bi-directional sequencing. The sequencing assays targeted different regions of the hemagglutinin gene than the ProF AST+ Assay and were specific for each of the Influenza A subtypes (A/H1, A/H3, and A/2009 HIN1). "True" seasonal A/H1, A/H3 or A/2009 H1N1 RNA positives, were considered as any sample that was tested positive for Influenza A by the ProFlu+ Assay, and had bidirectional sequencing data meeting pre-defined quality acceptance criteria, for both the forward and the reverse sequences that matched seasonal A/H1, A/H3, and A/2009 H1N1 sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database (www.ncbi.nlm.nih.gov), respectively, with acceptable E-values. "True" seasonal A/H1, A/H3 or A/2009 H1N1 RNA negatives were considered as any sample that was tested negative for Influenza A by the ProFlu+ Assay IVD, or any sample that was tested positive for Influenza A by the ProFlu+ Assay IVD, but was tested negative by the respective Influenza A subtype specific RT-PCR assay followed by bi-directional sequencing. Nucleic acid extractions on the clinical samples were carried out using either the Roche MagNA Pure LC system or the bioMérieux NucliSENS easyMAG during the clinical study.
3
A total of 874 prospective NP swab specimens were initially included in the prospective clinical trial. Thirty two (32) samples were excluded from the prospective clinical study data analysis because they remained "Unresolved" after repeat testing for either the ProFlu+ Assay (comparator assay), or the ProFAST+ Assay, or both assays, resulted in a total 842 eligible prospective specimens to be included in the prospective clinical study data analysis.
Of the prospective specimens run using the ProFAST+ Assay, 98.9% (864/874) of these specimens were successful on the first attempt. The remaining 10 (10/874 = 1.1%) gave "Unresolved" results on the first attempt. Unresolved results occur when the sample is negative for all three Influenza A subtype markers and the Internal Control, indicating potentially PCRinhibiting samples. Of the 10 "Unresolved" specimens on the first attempt with sufficient nucleic acid for retest, only 50.0% (5/10) gave a valid result on the second attempt (3 from Site 1, 1 from site 2, and 1 from Site 3). The remaining 5 were "Unresolved" on the second attempt.
| ProFlu+/Sequencing | |||||
|---|---|---|---|---|---|
| Positive Negative | Total | ||||
| oFAST Assay | Positive | રે રે | ga | 61 | Positive Percent |
| Agreement=100.0% | |||||
| (93.2% - 100.0%) 95% CI | |||||
| Negative | 0 | 781 | .781 | Negative Percent | |
| Agreement=99.0% | |||||
| (98.0% - 99.5%) 95% CI | |||||
| Total | રે રે | 789 | 842 |
Seasonal Influenza A/H1 Comparison Results
a Two (2) samples were negative for Influenza A by the ProFlu+ Assay, but positive for seasonal A/H1 by bi-directional sequence analysis. One (1) sample was negative for Influenza A by the ProFlu+ Assay, and negative for seasonal A/H1 by bidirectional sequence analysis, but positive for Influenza A, un-subtyptable, by the FDA cleared CDC rRT-PCR Influenza Panel. Five (5) samples were positive for Influenza A by the ProFlu+ Assay, negative for A/H1, A/H3 and A/2009 H1N1 by bidirectional sequence analysis, but positive for A/H1 by the FDA cleared CDC rRT-PCR Influenza Panel.
Seasonal Influenza A/H3 Comparison Results
| ProFlu+/Sequencing | ||||||
|---|---|---|---|---|---|---|
| Positive | Negative | Total | ||||
| ProFAST+ | ||||||
| Assay | Positive | 25 | 3a | 28 | Positive Percent | |
| Agreement=100.0% | ||||||
| (86.7% - 100.0%) 95% CI | ||||||
| Negative | 0 | 814 | 814 | Negative Percent | ||
| Agreement=99.6% | ||||||
| (98.9% - 99.9%) 95% CI | ||||||
| Total | 25 | 817 | 842 |
4 One (1) sample was negative for Influenza A by the ProFlu+ Assay, also negative for seasonal A/H1 and A/H3, and A/2009 H1N1 by bi-directional sequence analysis. One (1) sample was positive for Influenza A by the ProPlu+ Assay, negative for A/H1, A/H3 and A/2009 H1N1 by bi-directional sequence analysis, but positive for A/H3 by the FDA cleared CDC rRT-PCR Influenza Panel. One (1) sample was positive for Influenza A by the ProFit+ for A/H/ and negative for A/H3 and A/2009 H1N1 by bi-directional sequence analysis.
4
| 2009 H1N1 Influenza Comparison Results | ||
|---|---|---|
| ProFlu+/Sequencing | ||||||
|---|---|---|---|---|---|---|
| Positive | Negative | Total | ||||
| ProFAST+ | ||||||
| Assay | Positive | 62 | 0 | 62 | Positive Percent | |
| Agreement=95.4% | ||||||
| (87.3% - 98.4%) 95% CI | ||||||
| Negative | 3 | 777 | 780 | Negative Percent | ||
| Agreement=100.0% | ||||||
| (99.5% - 100.0%) 95% CI | ||||||
| Total | 65 | 777 | 842 |
Retrospective Study
In addition to the prospective clinical study, two clinical sites also performed testing using retrospective samples that were collected from January - March, 2008, January - November 2009, and March 2010. The ProFAST+ Assay was compared to the same composite comparator/reference method that was employed for the prospective study to determine clinical Percent Positive Agreement and Percent Negative Agreement. A total of 160 retrospective nasopharyngeal (NP) swab samples were included in the retrospective study.
Demographic details for this patient population are summarized in the table below.
| Gender and Age Demographic Detail for ProFAST+ Retrospective Stuc | |
|---|---|
| Sex | Number of Subjects |
| Female | 74 (46.3%)* |
| Male | 84 (52.5%)* |
| Age | |
| ≤ 5 years | 25 (15.6%) |
| 6 - 21 years | 24 (15.0%) |
| 22 - 59 years | 91 (56.9%) |
| > 60 years | 20(12.5%) |
ー
*For two of the subjects, the gender was unknown.
5
Seasonal Influenza A/H1 Comparison Results
| ProFlu+/Sequencing | |||||
|---|---|---|---|---|---|
| Positive | Negative | Total | |||
| ProFAST+ | |||||
| Assay | Positive | 17 | 1a | 18 | Positive Percent Agreement=94.4% |
| (74.3% - 99.0%) 95% CI | |||||
| Negative | 1 | 141 | 142 | Negative Percent Agreement=99.3% | |
| (96.1% - 99.9%) 95% CI | |||||
| Total | 18 | 142 | 160 |
4 One (1) sample was negative for Influenza A by the ProFlu+ Assay, but positive for seasonal A/H1 by bi-directional sequence analysis.
Seasonal Influenza A/H3 Comparison Results
| ProFlu+/Sequencing | |||||
|---|---|---|---|---|---|
| Positive | Negative | Total | |||
| ProFAST+ | |||||
| Assay | Positive | 72 | 0 | 72 | Positive Percent |
| Agreement=100.0% | |||||
| (94.9% - 100.0%) 95% CI | |||||
| Negative | 0 | 88 | 88 | Negative Percent | |
| Agreement=100.0% | |||||
| (95.8% - 100.0%) 95% CI | |||||
| Total | 72 | 88 | 160 |
2009 H1N1 Influenza A Comparison Results
| ProFAST+ Assay | ProFlu+/Sequencing | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Positive | 25 | 0 | 25 | Positive Percent |
| Agreement=100.0% | ||||
| (86.7% - 100.0%) 95% CI | ||||
| Negative | 0 | 135 | 135 | Negative Percent |
| Agreement=100.0% | ||||
| (97.2% - 100.0%) 95% CI | ||||
| Total | 25 | 135 | 160 |
6
Reproducibility
The reproducibility of the ProFAST+ Assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 18 simulated samples that included medium positive, low positive (near the assay limit of detection, ≥ 95% positive), and high negative (below the assay limit of detection,