XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)

{0}------------------------------------------------ # EVALUATION OF AUTOMATIC CLASS III DESIGNATION (DE NOVO) FOR xTAG® GASTROINTESTINAL PATHOGEN PANEL (GPP) DECISION SUMMARY - K121454 A. 510(k) Number: - B. Purpose for Submission: Clearance of new assay C. Measurand: · Campylobacter (C. jejuni, C. coli and C. lari only) · Clostridium difficile (C. difficile) toxin A/B • Cryptosporidium (C. parvum and C. hominis only) · Escherichia coli (E. coli) O157 · Enterotoxigenic E. coli (ETEC) LT/ST • Giardia (G. lamblia only - also known as G. intestinalis and G. duodenalis) • Norovirus GI/GII • Rotavirus A · Salmonella (see Analytical Reactivity section for a list of serotypes detected) - · Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 - Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae) in human stool samples. - D. Type of Test: Qualitative nucleic acid multiplex test - E. Applicant: Luminex Molecular Diagnostics, Inc. - F. Proprietary and Established Names: xTAG® Gastrointestinal Pathogen Panel (GPP) - G. Regulatory Information: FDA identifies this generic type of device as: A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. {1}------------------------------------------------ ### 1. New Regulation Number: 21 CFR 866.3990 - Gastrointestinal microorganism multiplex nucleic acid-based assay - 2. Classification: Class II - 3. Product code: PCH, NSU, JJH - 4. Panel: Microbiology (83) ### H. Intended Use: - 1. Intended use(s): The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral. parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. The following pathogen types, subtypes and toxin genes are identified using the xTAG® GPP: - · Campylobacter (C. jejuni, C. coli and C. lari only) - · Clostridium difficile (C. difficile) toxin A/B - · Cryptosporidium (C. parvum and C. hominis only) - Escherichia coli (E. coli) O157 - Enterotoxigenic Escherichia coli (ETEC) LT/ST - · Giardia (G. lamblia only also known as G. intestinalis and G. duodenalis) - · Norovirus GI/GII - Rotavirus A - · Salmonella - · Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 - · Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae) The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation, laboratory findings and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. ## xTAG® GPP positive results are presumptive and must be confirmed by FDA- {2}------------------------------------------------ ### cleared tests or other acceptable reference methods. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out coinfection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAGGastrointestinal Pathogen Panel results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. # xTAG® GPP is not intended to monitor or guide treatment for C. difficile infections. The xTAG® GPP is indicated for use with the Luminex® 100/200™ instrument. - 2. Indication(s) for use: Same as intended use. - 3. Special conditions for use statement(s): For prescription use only. Manufacturer must provide device-specific user training to facilities prior to using the device. - 4. Special instrument requirements: Extraction: Biomerieux NucliSens® EasyMag® instrument Analysis: Luminex® 100/200™ instruments with xPONENT® software #### I. Device Description: The Luminex Molecular Diagnostics xTAG GPP consists of kit reagents and software. The reagents in conjunction with a thermal cycler are used to perform nucleic acid amplification (reverse transcription-polymerase chain reaction, or RT-PCR/PCR), and the protocol configuration file is used to generate results while the data analysis software (TDAS GPP (US)) is used to analyze the results from the Luminex Corporation Luminex 100/200 instrument system (which includes the xPONENT core software). The components of the xTAG GPP kit are contained within 2 boxes (one that is frozen, and one that is refrigerated). The kit is shipped with the xTAG GPP CD which contains the xTAG GPP T-A (LX) protocol configuration file and the TDAS GPP (US) software. The instrument is shipped with the xPONENT software. {3}------------------------------------------------ The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) incorporates multiplex reverse transcription and polymerase chain reaction (RT-PCR / PCR) with Luminex's proprietary universal tag sorting system on the Luminex platform. The assay also detects an internal control (bacteriophage MS2) that is added to each sample prior to extraction. Each sample is pre-treated prior to extraction and is then put through extraction using the Biomerieux NucliSens EasyMag kit (product code JJH, class I, an IVD-labeled automated system for nucleic acid extraction). Post-extraction, for each sample, 10 uL of extracted nucleic acid is amplified in a single multiplex RT-PCR/PCR reaction. Each target or internal control in the sample results in PCR amplicons ranging from 58 to 202 bp (not including the 24-mer tag). A five uL aliquot of the RT-PCR product is then added to a hybridization/detection containing bead populations coupled to sequences from the Universal Array ("antitags"), streptavidin, R-phycoerythrin conjugate. Each Luminex bead population detects a specific microbial target or control through a specific tag/anti-tag hybridization reaction. Following the incubation of the RT-PCR products with the xTAG GPP Bead Mix and xTAG Reporter Buffer, the Luminex instrument sorts and reads the hybridization/detection reactions. A signal, or median fluorescence intensity (MFI), is generated for each bead population. These fluorescence values are analyzed to establish the presence of bacterial, viral or parasitic targets and/or controls in each sample. A single multiplex reaction identifies all targets. The xTAG Data Analysis Software for the Gastrointestinal Pathogen Panel (TDAS GPP (US)) analyzes the data to provide a report summarizing which pathogens are present. Before data are analyzed, a user has the option to select a subset of the targets from the intended use of the xTAG GPP (for each sample). Consequently the remaining target results are masked and cannot be retrieved. Target results above or equal to the cutoff are considered positive, while target results below the cutoff are considered negative. For each sample analyzed by TDAS GPP (US), there are individual results for each of the targets and the internal control (bacteriophage MS2). ## J. Substantial Equivalence Information: - 1. Predicate device name(s): None - 2. Predicate 510(k) number(s): None - 3. Comparison with predicate: Not applicable {4}------------------------------------------------ # K. Standard/Guidance Document Referenced (if applicable): # Standards Referenced | | Standards<br>No. | Recognition<br>Number<br>(FDA) | Standards Title | Date | |----|------------------|--------------------------------|--------------------------------------------------------------------------------------|------------| | 1 | MM13-A | 7-191 | Collection, Transport, Preparation and<br>Storage of Specimens | 03/18/2009 | | 2 | EP15-A2 | 7-153 | User Verification of Performance for<br>Precision and Trueness (2nd edition) | 09/09/2008 | | 3 | EP05-A2 | 7-110 | Evaluation of Precision Performance of<br>Quantitative measurement Methods (2nd ed.) | 10/31/2005 | | 4 | EP07-A2 | 7-127 | Interference Testing in Clinical Chemistry<br>(2nd edition) | 05/21/2007 | | 5 | EP12-A2 | 7-152 | User Protocol for Evaluation f Qualitative<br>Test Performance (2nd edition) | 09/09/2008 | | 6 | EP17-A | 7-194 | Protocol for Determination of Limits of<br>Detection and Limits of Quantitation | 03/18/2009 | | 7 | EP14-A2 | 7-128 and<br>7-143 | Evaluation of Matrix Effects (2nd edition) | 06/01/2004 | | 8 | MM03-A2 | 7-132 | Molecular Diagnostic Methods for Infectious<br>Diseases (2nd edition) | 09/09/2008 | | 9 | CEN 13640 | 7-84 | Stability Testing of In Vitro Diagnostic<br>Reagents | 06/01/2004 | | 10 | ISO 14971 | 5-40 | Application of Risk Management to Medical<br>Devices | 09/12/2007 | # Guidance Documents Referenced | | Title | Date | |----|-----------------------------------------------------------------------|----------| | 1 | Establishing the Performance Characteristics of In Vitro Diagnostic | 11/29/10 | | | Devices for the Detection of Clostridium difficile | | | 2 | Class II Special Controls Guidance Document: Norovirus Serological | 03/09/12 | | | Reagents | | | 3 | Class II Special Controls Guidance Document: Instrumentation for | 03/10/05 | | | Clinical Multiplex Test Systems - Guidance for Industry and FDA Staff | | | ব | Guidance for the Content of Premarket Submissions for Software | 5/11/05 | | | Contained in Medical Devices | | | റ | Guidance document for Format for Traditional and Abbreviated 510(k)s | 08/12/05 | | 6 | Guidance on the CDRH Premarket Notification Review Program, | 06/30/86 | | | 510(k) Memorandum #K86-3 | | | 7 | The New 510(k) Paradigm - Alternate Approaches to Demonstrating | 03/20/98 | | | Substantial Equivalence in Premarket Notifications - Final Guidance | | | 8 | The 510(k) Program: Evaluating Substantial Equivalence in Premarket | 12/27/11 | | | Notifications [510(k)] | | | ರ | Draft Guidance for Industry and Food and Drug Administration Staff - | 10/17/12 | | | eCopy Program for Medical Device Submissions | | | 10 | Guidance for Industry and FDA Staff - Factors to Consider When | 03/28/12 | {5}------------------------------------------------ | | Making Benefit-Risk Determinations in Medical Device Premarket<br>Approval and De Novo Classifications | | |----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | 11 | Draft Guidance for Industry and Food and Drug Administration Staff -<br>De Novo Classification Process (Evaluation of Automatic Class III<br>Designation) | 10/03/11 | | 12 | Guidance for Industry and Food and Drug Administration Staff - FDA<br>and Industry Actions on Premarket Notification (510(k)) Submissions:<br>Effect on FDA Review Clock and Goals | 10/15/12 | # L. Test Principle: Human stool samples are pretreated and then subjected to nucleic acid extraction. For each sample, 10 uL of extracted nucleic acid is amplified in a single multiplex RT-PCR/PCR reaction. Each target or internal control in the sample results in PCR amplimers ranging from 58 to 202 bp (not including the 24-mer tag). A five uL aliquot of the RT-PCR product is then added to a hybridization/detection reaction containing bead populations coupled to sequences from the Universal Array ("antitags"), streptavidin, R-phycoerythrin conjugate. Each Luminex bead population detects a specific microbial target or control through a specific tag/anti-tag hybridization reaction. Following the incubation of the RT-PCR products with the xTAG GPP Bead Mix and xTAG Reporter Buffer, the Luminex instrument sorts and reads the hybridization/detection reactions. A signal or median fluorescence intensity (MFI) is generated for each bead population. These fluorescence values are analyzed to establish the presence or absence of bacterial, viral or parasitic targets and/or controls in each sample. A single multiplex reaction identifies all targets. ## M. Performance Characteristics (if/when applicable): ## 1. Analytical performance: ## a. Precision/Reproducibility: Site-to-site reproducibility was assessed for each of the indicated microbial targets and for mixed analyte samples (representing co-infected samples). Replicates of simulated samples were tested across 3 sites by 2 operators at each site. All sample replicates tested were prepared through serial dilutions of stock material (pre-treated negative stool spiked with a pathogen or positive stool) containing a microbial target from the intended use. Each sample replicate assayed in the study contained either a single microbial target or 2 microbial targets detected by xTAG GPP in addition to the internal control (bacteriophage MS2). For single analyte samples, dilutions tested fell into 1 of the following 3 categories: - 1. High Negative (HN): microbial target concentrations which generate MFI values not lower than 20-30% below the cut-off MFI for the indicated analyte - 2. Low Positive (LP): microbial target concentrations which generated MFI values that were 1-5X the cut-off MFI for the indicated analyte {6}------------------------------------------------ - 3. Moderate Positive (MP): microbial target concentrations which generated MFI values 7- 10X the cut-off MFI for the indicated analyte. For those samples prepared to simulate co-infections, one microbial target was present at the LP level defined above and the other at a High Positive (HP) level. HP levels were defined as follows: High Positive (HP) viral cultures were prepared to a concentration of 10° PFU/mL (10° TCID30/mL) or higher; High Positive (HP) bacterial cultures were prepared to a concentration of 106 CFU/mL or higher. Each sample replicate underwent a single pre-treatment and extraction step. All samples were extracted using the NucliSens EasyMAG extraction method. Extracted material was kept frozen at -70°C until testing. A total of 90 replicates were tested for each sample (3 replicates per run x 5 runs per operator x 2 operators per site x 3 sites = 90 replicates). Reproducibility was assessed both in terms of calls and MFI values. For single analyte samples prepared at the MP level, depending on the microbial target, 89/90 (99%) to 90/90 (100%) replicates generated a positive result. For LP dilutions, depending on the microbial target, the correct positive call was made in 80/90 (89%) to 90/90 (100%) replicates tested. The only exception in terms of LP detection was Cryptosporidium, due to the fact that the initial titer for this particular sample was below the targeted range of 1-5X the cut-off MFI. For HN dilutions, depending on the microbial target, the correct negative call was generated in as few as 54/90 (60%) replicates to as many as 90/90 (100%). Greater variability in the HN dilution, compared to the LP and MP dilution, was expected based on the fact that a microbial target is present in these samples at levels sufficient to generate MFI values 20-30% below the cut-off MFI, and based on the stochastic nature of end-point PCR in the presence of low levels of targeted analytes. Accordingly, percent variability, measured as the coefficient of variation (CV) for MFI values were lowest at the MP dilution and highest at the HN dilution. For dual analyte samples, all microbial targets generated a positive call when present as a HP dilution. When present at the LP concentration, 3 of the 6 microbial target combinations tested generated a positive call in 90/90 (100%) replicates tested. The following was observed for the remaining 3 targets present at LP concentrations in samples containing a second microbial target at HP concentrations: - 2/90 replicates of the ETEC (HP) / Salmonella (LP) sample generated a negative . call for Salmonella - . 4/90 replicates of the Salmonella (HP) / Rotavirus (LP) sample generated a negative call for rotavirus - . 12/90 replicates of the Rotavirus (HP) / Norovirus GII (LP) sample generated a negative call for norovirus {7}------------------------------------------------ {8}------------------------------------------------ | | Panel Member ID | Campylob-<br>actor<br>Low<br>Positive | Campylob-<br>actor<br>Medium<br>Positive | Campylob-<br>actor<br>High<br>Negative | C. difficile Toxin A/B<br>Low Positive | | C. difficile Toxin A/B<br>Medium Positive | | C. difficile Toxin A/B<br>High Negative | | Cryptospor-<br>idium hominis<br>Low Positive | Cryptospor-<br>idium hominis<br>Medium Positive | Cryptospor-<br>idium hominis<br>High Negative | Panel Member ID | <i>E. coli</i> O157<br>Low Positive | <i>E. coli</i> O157<br>Medium Positive | <i>E. coli</i> O157<br>High Negative | ETEC LT/ST<br>Low Positive<br>Probe 1 | ETEC LT/ST<br>Low Positive<br>Probe 2 | ETEC LT/ST<br>Medium Positive<br>Probe 1 | ETEC LT/ST<br>Medium Positive<br>Probe 2 | ETEC LT/ST<br>High Negative<br>Probe 1 | ETEC LT/ST<br>High Negative<br>Probe 2 | <i>Giardia</i><br>Low Positive | <i>Giardia</i><br>Medium Positive | <i>Giardia</i><br>High Negative | Panel Member ID | | Norovirus GI/GII<br>Low Positive | Norovirus GI/GII<br>Medium Positive | Norovirus GI/GII<br>High Negative | Rotavirus A<br>Low Positive | Rotavirus A<br>Medium Positive | Rotavirus A<br>High Negative | Salmonella*<br>Low Positive | | Salmonella*<br>Medium Positive | | Salmonella*<br>High Negative | | | | | | 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| | Concentration | $9.38x10^5$<br>CFU/mL | $3.75x10^6$<br>CFU/mL | $1.17x10^5$<br>CFU/mL | $3.75x10^6$<br>CFU/mL | $9.38x10^5$<br>CFU/mL | $1.50x10^7$<br>CFU/mL | $1.50x10^7$<br>CFU/mL | $2.34x10^5$<br>CFU/mL | $2.34x10^5$<br>CFU/mL | $6.21x10^3$<br>Copies/mL | $2.05x10^4$<br>Copies/mL | $6.37x10^2$<br>Copies/mL | Concentration | $2.34x10^5$<br>CFU/mL | $3.75x10^6$<br>CFU/mL | $2.93x10^4$<br>CFU/mL | $2.93x10^4$<br>CFU/mL | $9.37x10^5$<br>CFU/mL | $3.75x10^6$<br>CFU/mL | $3.75x10^6$<br>CFU/mL | $7.32x10^3$<br>CFU/mL | $7.32x10^3$<br>CFU/mL | $8.79x10^2$<br>Cells/mL | $3.25x10^3$<br>Cells/mL | $2.74x10^1$<br>Cells/mL | | | Probe 1 | Probe 2 | Probe 1 | Probe 2 | Probe 1 | Probe 2 | Probe 1 | Probe 2 | Probe 1 | Probe 2 | Probe 1 | Probe 2 | | | | | | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 5/30<br>16.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 28/30<br>93.3% | 17/30<br>56.7% | 30/30<br>100% | 30/30<br>100% | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 24/30<br>80% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | | Concentration | $1.2x10^3$<br>Copies/mL | $1.74x10^3$<br>Copies/mL | $4.64x10^3$<br>Copies/mL | $7.45x10^3$<br>Copies/mL | $5.84x10^1$<br>Copies/mL | $5.95x10^1$<br>Copies/mL | $2.24x10^4$<br>Copies/mL | $4.47x10^5$<br>Copies/mL | $1.29x10^3$<br>Copies/mL | $1.17x10^5$<br>CFU/mL | $1.17x10^5$<br>CFU/mL | $9.38x10^5$<br>CFU/mL | $9.38x10^5$<br>CFU/mL | $3.66x10^3$<br>CFU/mL | $3.66x10^3$<br>CFU/mL | | | | 25th Percentile MFI | 1081.0 | 2022.0 | 183.5 | 259.5 | 256.0 | 918.0 | 1821.0 | 38.5 | 67.0 | 165.0 | 748.0 | 48.0 | 25th Percentile MFI | 546.0 | 2494.0 | 74.0 | 294.0 | 1387.0 | 2203.0 | 2097.0 | 53.0 | 25.0 | 541.0 | 1145.0 | 51.0 | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 26/30<br>86.7% | 30/30<br>100% | 29/30<br>96.7% | 30/30<br>100% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 24/30<br>80% | 29/30<br>96.7% | | | Site 1 | Median MFI Value | 1283.3 | 2269.0 | 275.5 | 363.0 | 297.0 | 1113.0 | 1936.3 | 48.5 | 80.5 | 265.0 | 838.5 | 54.0 | Site 1 | Median MFI Value | 685.0 | 2585.0 | 104.3 | 344.0 | 1468.5 | 2287.8 | 2149.3 | 67.5 | 36.5 | 657.8 | 1303.3 | 59.5 | | 25th Percentile MFI | 477.0 | 860.0 | 1405.5 | 1635.0 | 50.0 | 90.0 | 212.5 | 546.0 | 50.0 | 831.5 | 469.0 | 2602.0 | 2744.0 | 43.0 | 38.0 | | | 75th Percentile MFI | 1561.0 | 2520.5 | 329.5 | 413.5 | 383.0 | 1317.0 | 2010.0 | 55.5 | 105.0 | 325.0 | 895.5 | 66.5 | | 75th Percentile MFI | 840.0 | 2673.0 | 140.0 | 408.5 | 1545.0 | 2356.0 | 2216.5 | 90.0 | 42.5 | 742.0 | 1392.0 | 76.5 | Site 1 | Median MFI Value | 554.5 | 941.8 | 1476.5 | 1797.5 | 64.3 | 108.8 | 315.8 | 762.0 | 60.5 | 938.5 | 591.0 | 2681.3 | 2870.0 | 75.3 | 44.5 | | | % CV | 23.40 | 13.06 | N/A | 32.66 | 31.19 | 16.73 | 8.11 | N/A | N/A | 35.37 | 15.89 | N/A | | % CV | 27.64 | 4.82 | N/A | 18.49 | 7.75 | 6.27 | 6.32 | N/A | N/A | 21.87 | 13.80 | N/A | | 75th Percentile MFI | 659.5 | 1177.0 | 1697.0 | 2059.0 | 78.0 | 132.0 | 480.0 | 1101.0 | 68.5 | 1189.0 | 787.0 | 2843.0 | 3039.5 | 146.0 | 78.0 | | | Agreement with<br>Expected Result | 27/30<br>90% | 30/30<br>100% | 19/30<br>63.3% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 29/30<br>96.7% | 17/30<br>56.7% | 27/30<br>90% | 29/30<br>96.7% | 30/30<br>100% | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 23/30<br>76.7% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 29/30<br>96.7% | 30/30<br>100% | | % CV | 26.14 | 23.87 | 12.92 | 19.34 | N/A | N/A | 59.70 | 56.62 | N/A | 23.48 | 37.04 | 6.01 | 6.07 | N/A | N/A | | | 25th Percentile MFI | 842.5 | 1924.5 | 99.0 | 235.5 | 315.0 | 726.0 | 2529.0 | 29.0 | 85.0 | 284.5 | 827.0 | 49.0 | Site 2 | 25th Percentile MFI | 506.0 | 2618.0 | 69.0 | 317.0 | 1617.0 | 2532.5 | 2443.0 | 51.5 | 36.5 | 752.0 | 1506.0 | 41.0 | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 29/30<br>96.7% | 30/30<br>100% | 26/30<br>86.7% | 30/30<br>100% | 28/30<br>93.3% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 23/30<br>76.7% | 22/30<br>73.3% | | Site 2 | Median MFI Value | 1075.3 | 2086.0 | 130.3 | 362.8 | 412.3 | 988.5 | 2723.3 | 40.8 | 141.0 | 327.8 | 1059.0 | 56.5 | | Median MFI Value | 707.8 | 3012.3 | 93.8 | 419.3 | 1729.0 | 2641.0 | 2537.8 | 74.0 | 46.5 | 901.5 | 1579.8 | 57.0 | | 25th Percentile MFI | 492.0 | 743.0 | 1337.0 | 1643.0 | 46.0 | 104.0 | 212.0 | 888.0 | 54.0 | 867.0 | 565.5 | 3098.0 | 3289.0 | 42.0 | 30.0 | | | 75th Percentile MFI | 1520.0 | 2515.0 | 200.0 | 444.0 | 509.0 | 1263.0 | 2864.0 | 45.0 | 166.5 | 535.5 | 1140.5 | 64.0 | | 75th Percentile MFI | 947.0 | 3159.0 | 120.0 | 494.5 | 1867.0 | 2759.5 | 2619.0 | 106.5 | 52.5 | 1053.0 | 1953.0 | 72.5 | Site 2 | Median MFI Value | 587.0 | 1004.0 | 1620.0 | 2012.5 | 58.8 | 115.5 | 399.5 | 1264.0 | 64.0 | 992.0 | 706.3 | 3272.8 | 3494.0 | 96.0 | 44.3 | | | % CV | 51.66 | 18.76 | N/A | 37.17 | 36.61 | 33.20 | 8.95 | N/A | N/A | 34.46 | 26.02 | N/A | | % CV | 42.42 | 12.44 | N/A | 31.18 | 18.92 | 6.26 | 7.77 | N/A | N/A | 21.63 | 25.88 | N/A | | 75th Percentile MFI | 765.0 | 1288.5 | 1777.0 | 2201.0 | 77.0 | 131.0 | 675.0 | 1548.0 | 72.5 | 1143.5 | 894.0 | 3393.0 | 3678.5 | 191.0 | 203.0 | | | Agreement with<br>Expected Result | 25/30<br>83.3% | 30/30<br>100% | 30/30<br>100% | 21/30<br>70% | 25/30<br>83.3% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 2/30<br>6.7% | 30/30<br>100% | 30/30<br>100% | Site 3 | Agreement with<br>Expected Result | 27/30<br>90% | 30/30<br>100% | 30/30<br>100% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 25/30<br>83.3% | 30/30<br>100% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | | % CV | 32.86 | 27.61 | 17.82 | 15.20 | N/A | N/A | 79.96 | 35.73 | N/A | 28.89 | 44.35 | 15.27 | 13.89 | N/A | N/A | | | 25th Percentile MFI | 160.0 | 416.0 | 42.5 | 145.0 | 187.0 | 620.0 | 1491.0 | 37.5 | 55.0 | 122.0 | 505.0 | 51.0 | | 25th Percentile MFI | 229.0 | 1391.0 | 53.0 | 425.5 | 1265.0 | 2058.5 | 1723.0 | 69.0 | 36.0 | 278.5 | 817.0 | 49.5 | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 28/30<br>93.3% | 30/30<br>100% | 27/30<br>90% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 28/30<br>93.3% | | Site 3 | Median MFI Value | 258.5 | 757.5 | 55.5 | 195.3 | 213.0 | 790.0 | 1691.0 | 44.0 | 67.0 | 160.8 | 559.0 | 61.8 | | Median MFI Value | 314.5 | 1595.3 | 67.5 | 477.0 | 1384.5 | 2212.3 | 1903.3 | 95.0 | 43.0 | 412.3 | 1065.0 | 58.5 | | 25th Percentile MFI | 398.5 | 614.0 | 1088.0 | 1231.0 | 49.5 | 92.0 | 228.0 | 628.0 | 58.0 | 753.5 | 641.0 | 2178.0 | 2383.0 | 46.0 | 36.5 | | | 75th Percentile MFI | 369.0 | 1086.5 | 65.0 | 258.5 | 250.0 | 945.0 | 1851.0 | 56.0 | 76.0 | 191.0 | 652.0 | 75.0 | | 75th Percentile MFI | 346.0 | 1773.5 | 78.0 | 668.0 | 1473.0 | 2326.5 | 2028.0 | 146.5 | 50.0 | 574.5 | 1214.0 | 72.5 | Site 3 | Median MFI Value | 491.8 | 676.5 | 1218.3 | 1353.0 | 62.0 | 107.0 | 332.5 | 748.0 | 68.0 | 936.0 | 691.0 | 2323.5 | 2526.3 | 65.5 | 56.3 | | | % CV | 48.96 | 49.92 | N/A | 38.35 | 28.36 | 36.07 | 23.66 | N/A | N/A | 32.52 | 19.57 | N/A | | % CV | 39.79 | 34.37 | N/A | 37.50 | 22.80 | 29.95 | 30.36 | N/A | N/A | 35.20 | 24.62 | N/A | | 75th Percentile MFI | 603.5 | 897.0 | 1324.0 | 1735.0 | 83.5 | 136.0 | 474.5 | 978.5 | 88.0 | 1154.0 | 925.0 | 2564.0 | 2773.5 | 99.0 | 91.5 | | | Total Agreement with<br>Expected Result | 82/90<br>91.1% | 90/90<br>100% | 54/90<br>60% | 80/90<br>88.9% | 85/90<br>94.4% | 89/90<br>98.9% | 90/90<br>100% | 89/90<br>98.9% | 75/90<br>83.3% | 46/90<br>51.1% | 89/90<br>98.9% | 90/90<br>100% | | Total Agreement with<br>Expected Result | 87/90<br>96.7% | 90/90<br>100% | 77/90<br>85.6% | 88/90<br>97.8% | 90/90<br>100% | 90/90<br>100% | 90/90<br>100% | 85/90<br>94.4% | 90/90<br>100% | 89/90<br>98.9% | 89/90<br>98.9% | 90/90<br>100% | | % CV | 27.79 | 22.98 | 19.21 | 21.50 | N/A | N/A | 54.09 | 33.58 | N/A | 26.03 | 34.62 | 20.44 | 22.38 | N/A | N/A | | | 95% CI | 83.4%-<br>95.4% | 95.9%-<br>100.0% | 49.7%-<br>69.5% | 80.7%-<br>93.9% | 87.6%-<br>97.6% | 94.0%-<br>99.8% | 95.9%-<br>100.0% | 94.0%-<br>99.8% | 74.3%-<br>89.6% | 41.0%-61.2% | 94.0%-99.8% | 95.9%-100.0% | | 95% CI | 90.7%-<br>98.9% | 95.9%-<br>100.0% | 76.9%-<br>91.4% | 92.3%-<br>99.4% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 87.6%-<br>97.6% | 95.9%-<br>100.0% | 94.0%-99.8% | 94.0%-99.8% | 95.9%-100.0% | | Total Agreement with<br>Expected Result | 90/90<br>100% | 90/90<br>100% | 90/90<br>100% | 90/90<br>100% | 89/90<br>98.9% | 90/90<br>100% | 80/90<br>88.9% | 90/90<br>100% | 84/90<br>93.3% | 90/90<br>100% | 89/90<br>98.9% | 90/90<br>100% | 90/90<br>100% | 77/90<br>85.6% | 79/90<br>87.8% | | | Overall 25th Percentile<br>MFI | 298.0 | 1086.5 | 62.0 | 218.0 | 219.0 | 781.0 | 1801.5 | 35.0 | 61.5 | 161.0 | 584.0 | 48.5 | | Overall 25th Percentile<br>MFI | 338.0 | 1773.5 | 64.0 | 328.0 | 1387.0 | 2203.0 | 1978.0 | 55.5 | 33.0 | 472.0 | 1089.0 | 45.0 | | 95% CI | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 94.0%-<br>99.8% | 95.9%-<br>100.0% | 80.4%-<br>93.9% | 95.9%-<br>100.0% | 86.2%-<br>96.9% | 95.9%-<br>100.0% | 94.0%-<br>99.8% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 76.9%-<br>91.4% | 79.4%-<br>93.0% | | | Overall Median<br>MFI Value | 1003.0 | 1990.3 | 121.5 | 281.5 | 283.0 | 954.5 | 1966.3 | 43.5 | 79.3 | 260.0 | 801.3 | 58.0 | | Overall Median MFI<br>Value | 537.0 | 2548.3 | 82.8 | 415.3 | 1499.5 | 2327.0 | 2170.8 | 76.3 | 41.3 | 636.0 | 1310.0 | 59.0 | | Overall 25th Percentile<br>MFI | 440.0 | 690.0 | 1233.0 | 1484.0 | 49.0 | 90.5 | 221.0 | 685.0 | 54.0 | 807.0 | 546.0 | 2401.5 | 2616.0 | 43.0 | 36.0 | | | Overall 75th Percentile<br>MFI | 1315.0 | 2326.0 | 241.0 | 382.5 | 397.5 | 1193.5 | 2529.0 | 52.5 | 121.0 | 325.0 | 944.0 | 70.0 | | Overall 75th Percentile<br>MFI | 764.5 | 2746.5 | 116.0 | 489.0 | 1650.5 | 2615.0 | 2456.5 | 106.5 | 49.5 | 827.5 | 1539.0 | 72.5 | | Overall Median MFI<br>Value | 548.3 | 887.3 | 1439.0 | 1733.8 | 62.0 | 112.8 | 336.5 | 861.8 | 63.0 | 956.0 | 690.0 | 2712.8 | 2986.5 | 72.8 | 48.0 | | | Overall<br>% CV | 66.01 | 45.24 | N/A | 43.21 | 44.32 | 32.01 | 25.52 | N/A | N/A | 50.13 | 30.95 | N/A | | Overall<br>% CV | 51.27 | 28.85 | N/A | 36.90 | 21.69 | 18.84 | 20.99 | N/A | N/A | 38.43 | 29.58 | N/A | | Overall 75th Percentile<br>MFI | 693.0 | 1093.0 | 1698.0 | 2059.0 | 80.0 | 132.0 | 510.5 | 1318.0 | 76.5 | 1154.0 | 874.0 | 3131.0 | 3425.0 | 139.5 | 108.5 | | | Overall<br>% CV | 30.29 | 28.23 | 19.58 | 21.71 | N/A | N/A | 70.30 | 46.14 | N/A | 26.06 | 40.15 | 20.01 | 19.72 | N/A | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | # Reproducibility of Overall Total Raw Median MFI values for All Targets in xTAG GPP {9}------------------------------------------------ {10}------------------------------------------------ *The Salmonella positive (Ne) calls presented in this able, represent when the signal from the individual Salmonella probe in question is either above or below the assy thres for a positive call, it does not represent a true as information from both probes is required to determine the call for this target. {11}------------------------------------------------ | Panel Member ID | STEC stx1/stx2 Low Positive | | STEC stx1/stx2 Medium Positive | | STEC stx1/stx2 High Negative | | Shigella Low Positive | Shigella Medium Positive | Shigella High Negative | | |--------------------------------------|-----------------------------|--------------------|--------------------------------|--------------------|------------------------------|--------------------|-----------------------|--------------------------|------------------------|------| | | Probe 1 | Probe 2 | Probe 1 | Probe 2 | Probe 1 | Probe 2 | | | | | | Concentration | $9.38x10^5$ CFU/mL | $2.34x10^5$ CFU/mL | $3.75x10^6$ CFU/mL | $3.75x10^6$ CFU/mL | $2.93x10^4$ CFU/mL | $2.93x10^4$ CFU/mL | $7.32x10^3$ CFU/mL | $2.93x10^4$ CFU/mL | $2.29x10^2$ CFU/mL | | | Agreement with Expected Result | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 29/30<br>96.7% | 29/30<br>96.7% | 30/30<br>100% | 27/30<br>90% | | | 25th Percentile MFI | 715.5 | 296.5 | 1573.0 | 1756.0 | 42.0 | 58.5 | 589.0 | 1102.0 | 43.0 | | | Site 1<br> | Median MFI Value | 813.0 | 414.8 | 1632.5 | 1830.3 | 57.0 | 85.3 | 644.5 | 1171.0 | 51.0 | | 75th Percentile MFI | 894.0 | 509.5 | 1676.5 | 1881.0 | 76.0 | 105.0 | 730.0 | 1240.5 | 80.0 | | | % CV | 18.73 | 25.75 | 8.56 | 5.86 | N/A | N/A | 25.21 | 12.04 | N/A | | | Agreement with Expected Result | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 28/30<br>93.3% | 23/30<br>76.7% | 30/30<br>100% | 30/30<br>100% | 25/30<br>83.3% | | | 25th Percentile MFI | 875.0 | 455.5 | 1974.0 | 2086.0 | 45.0 | 64.0 | 623.0 | 1255.0 | 42.0 | | | Site 2 | Median MFI Value | 995.3 | 542.0 | 2051.8 | 2286.3 | 58.0 | 102.0 | 707.3 | 1316.3 | 64.8 | | 75th Percentile MFI | 1140.0 | 607.0 | 2198.0 | 2387.0 | 100.0 | 148.0 | 866.5 | 1375.0 | 125.5 | | | % CV | 23.38 | 22.15 | 11.04 | 8.77 | N/A | N/A | 23.68 | 10.25 | N/A | | | Agreement with Expected Result | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 23/30<br>76.7% | 28/30<br>93.3% | 30/30<br>100% | 30/30<br>100% | | | 25th Percentile MFI | 412.0 | 412.0 | 1027.5 | 1509.5 | 50.0 | 68.5 | 307.5 | 678.5 | 45.0 | | | Site 3 | Median MFI Value | 494.5 | 522.3 | 1136.5 | 1641.8 | 57.0 | 103.3 | 432.0 | 826.3 | 56.0 | | 75th Percentile MFI | 583.0 | 597.0 | 1273.0 | 1726.0 | 71.0 | 148.0 | 495.0 | 951.0 | 71.0 | | | % CV | 29.27 | 28.07 | 29.24 | 30.35 | N/A | N/A | 41.88 | 39.24 | N/A | | | Total Agreement with Expected Result | 89/90<br>98.9% | 90/90<br>100% | 90/90<br>100% | 90/90<br>100% | 88/90<br>97.8% | 75/90<br>83.3% | 87/90<br>96.7% | 90/90<br>100% | 82/90<br>91.1% | | | 95% CI | 94.0%-<br>99.8% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 92.3%-<br>99.4% | 74.3%-<br>89.6% | 90.7%-<br>98.9% | 95.9%-<br>100.0% | 83.4%-<br>95.4% | | | Overall 25th Percentile MFI | 564.5 | 386.5 | 1273.0 | 1663.5 | 45.0 | 65.0 | 438.0 | 901.0 | 43.0 | | | Overall Median MFI Value | 769.0 | 490.3 | 1622.3 | 1848.0 | 57.0 | 96.5 | 623.8 | 1171.0 | 57.0 | | | Overall 75th Percentile MFI | 958.0 | 557.5 | 1984.5 | 2225.0 | 77.5 | 134.0 | 727.0 | 1313.0 | 96.5 | | | Overall % CV | 34.84 | 27.39 | 28.49 | 21.93 | N/A | N/A | 35.16 | 26.97 | N/A | | {12}------------------------------------------------ | | | Rotavirus A Low Positive/<br>Norovirus GII High Positive | | Rotavirus A High Positive/<br>Norovirus GII Low Positive | | Rotavirus A Low Positive/<br>Salmonella* High Positive | | | Rotavirus A High Positive/<br>Salmonella* Low Positive | | | |--------|-----------------------------------------|----------------------------------------------------------|--------------------------------|----------------------------------------------------------|-------------------------------|--------------------------------------------------------|------------------------------|---------------------|--------------------------------------------------------|-----------------------------|-------------------| | | Panel Member ID | Rotavirus A<br>Low Positive | Norovirus GII<br>High Positive | Rotavirus A<br>High Positive | Norovirus GII<br>Low Positive | Rotavirus<br>A Low | Salmonella*<br>High Positive | | Rotavirus<br>A High | Salmonella*<br>Low Positive | | | | | | Probe 2 | | Probe 2 | Positive | Probe 1 | Probe 2 | Positive | Probe 1 | Probe 2 | | | Concentration | 4.47x103<br>Copies/mL | 2.94x104<br>Copies/mL | 1.02x105 Copies/mL | 3.93x103 Copies/mL | 3.78x103<br>Copies/mL | 3.75 x100<br>CFU/mL | 3.75 x10°<br>CFU/mL | 1.93x104<br>Copies/mL | 1.17x103<br>CFU/mL | 1.17x10<br>CFU/mL | | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | | | 25th Percentile MFI | 303.5 | 2181.0 | 1995.0 | 707.0 | 207.0 | 2958.0 | 3220.0 | 1583.0 | 1043.0 | 586.0 | | Site 1 | Median MFI Value | 416.8 | 2306.0 | 2386.0 | 905.0 | 302.8 | 3062.5 | 3368.3 | 1944.3 | 1188.8 | 664.0 | | | 75th Percentile MFI | 665.0 | 2548.0 | 2612.0 | 1053.0 | 543.0 | 3200.0 | 3508.0 | 2344.0 | 1303.0 | 835.0 | | | % CV | 61.05 | 13.21 | 25.39 | 24.85 | 71.77 | 9.04 | 7.37 | 31.09 | 17.37 | 32.68 | | Site 2 | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 28/30<br>93.3% | 29/30<br>96.7% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | | | 25th Percentile MFI | 460.0 | 1699.5 | 2424.0 | 605.0 | 311.0 | 3430.0 | 3549.0 | 2206.0 | 1235.5 | 902.0 | | | Median MFI Value | 625.0 | 2086.8 | 3164.5 | 740.0 | 432.0 | 3564.5 | 3770.8 | 2430.8 | 1363.0 | 1060.0 | | | 75th Percentile MFI | 1154.0 | 2382.0 | 3660.5 | 877.0 | 527.5 | 3633.5 | 3924.0 | 2708.5 | 1547.0 | 1398.0 | | | % CV | રતે તેવ | 19.54 | 24.17 | 31.49 | 41.02 | 6.15 | 8.07 | 20.78 | 18.51 | 37.00 | | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 20/30<br>66.7% | 28/30<br>93.3% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | | | 25th Percentile MFI | 402.5 | 1277.0 | 1290.5 | 331.5 | 257.0 | 2501.0 | 2759.0 | 1040.5 | 782.0 | 603.0 | | Site 3 | Median MFI Value | 625.5 | 1486.5 | 1843.0 | 388.5 | 357.8 | 2750.3 | 2985.5 | 1319.8 | 918.5 | 774.5 | | | 75th Percentile MFI | 796.0 | 2202.0 | 2538.0 | 613.0 | 601 -5 | 2934.5 | 3106.5 | 1765.0 | 1071.0 | 899.0 | | | % CV | 71.79 | 30.68 | 38.78 | 39.06 | 80.66 | 15.47 | 13.60 | 50:31 | 20.20 | 33.99 | | | Total Agreement with<br>Expected Result | 90/90<br>100% | 90/90<br>100% | 90/90<br>100% | 78/90<br>86.7% | 86/90<br>95.6% | 90/90<br>100% | 90/90<br>100% | 90/90<br>100% | 90/90<br>100% | 90/90<br>100% | | | 95% CI | 95.9%-100.0% | 95.9%-100.0% | 95.9%-100.0% | 78.1%-92.2% | 89.1%-98.3% | 95.9%-100.0% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | 95.9%-<br>100.0% | | | Overall 25th Percentile<br>MFI | 373.0 | 1675.0 | 1846.0 | 432.0 | 261.0 | 2782.0 | 3049.0 | 1439.0 | 947.0 | 608.0 | | | Overall Median<br>MFI Value | 568.0 | 2181.0 | 2412.3 | 700.0 | 385.3 | 3079.8 | 3365.5 | 1964.5 | 1146.8 | 791.3 | | | Overall 75th Percentile<br>MFI | 887.0 | 2386.0 | 3015.5 | 890.5 | 566.5 | 3462.0 | 3673.0 | 2455.0 | 1335.0 | 1065.5 | | | Overall<br>% CV | 67.14 | 25.14 | 34.55 | 41.19 | 67.20 | 14.25 | 13.41 | 38.01 | 24.60 | 41.11 | ### Reproducibility of Overall Total Raw Median MFI values for Mixed Analytes in xTAG GPP *The Salmonella positive (Ne) calls presented in this table, represent when the signal from the individual Salmonella probe in question is ether above or below the assorthesh for a positive call, it does not represent a true as information from both probes is required to determine the call for this target. {13}------------------------------------------------ | | Panel Member ID | ETEC Low Positive | | | Salmonella* High Positive | ETEC High Positive | | Salmonella* Low Positive | | |--------|-----------------------------------------|--------------------|--------------------|--|---------------------------|--------------------|--------------------|--------------------------|--------------------| | | | Probe 1 | Probe 2 | | | Probe 1 | Probe 2 | Probe 1 | Probe 2 | | | Concentration | $9.37x10^5$ CFU/mL | $9.37x10^5$ CFU/mL | | $3.75 x10^6$ CFU/mL | $7.50x10^6$ CFU/mL | $7.50x10^6$ CFU/mL | $1.17x10^5$ CFU/mL | $1.17x10^5$ CFU/mL | | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 29/30<br>96.7% | | | 25th Percentile MFI | 1331.0 | 516.0 | | 3013.0 | 2477.0 | 2180.0 | 1111.5 | 720.0 | | Site 1 | Median MFI Value | 1526.3 | 588.0 | | 3083.8 | 2559.0 | 2361.8 | 1269.0 | 919.5 | | | 75th Percentile MFI | 1713.5 | 654.0 | | 3221.0 | 2723.5 | 2452.0 | 1501.0 | 1189.0 | | | % CV | 13.73 | 18.49 | | 6.22 | 9.94 | 8.91 | 22.23 | 32.28 | | | Agreement with<br>Expected Result | 30/30<br>100% | 30/30<br>100% | | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | 30/30<br>100% | | | 25th Percentile MFI | 2153.0 | 883.0 | | 3442.0 | 3175.0 | 2717.5 | 1315.0 | 882.0 | | Site 2 | Median MFI Value | 2508.8 | 1104.8 | | 3657.0 | 3399.0 | 2879.5 | 1378.0 | 1065.0 | | | 75th Percentile MFI | 2788.0 | 1378.0 | | 3789.0 | 3519.0 | 3111.0 | 1641.0 | 1236.0 | | | % CV | 18.39 | 28.80 | | 9.15 | 8.61 | 9.31 | 2…