Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

Q: Who is the manufacturer of Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

Nucleix , Ltd. filed the 510(k) submission for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C (K203245).

Q: What is the FDA product code for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

MMW. It is classified under 21 CFR 866.6010 as a Class 2 device in the Immunology panel.

Q: What is the regulatory pathway for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

UroVysion Bladder Cancer Recurrence Kit (k013785).

Q: Who can help prepare an FDA 510(k) submission like Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K203245 · Nucleix , Ltd. · MMW · May 4, 2023 · Immunology

Device Facts

Record ID	K203245
Device Name	Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
Applicant	Nucleix , Ltd.
Product Code	MMW · Immunology
Decision Date	May 4, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.6010
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Bladder EpiCheck Kit is intended for the qualitative detection of DNA methylation patterns of 15 loci in human DNA that are associated with transitional cell carcinoma of the bladder. The test is performed on voided urine samples and run on the ABI 7500 Fast Dx Real-Time PCR system. Bladder EpiCheck Kit is indicated for use as a non-invasive method to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with Non-Muscle Invasive Bladder Cancer.

Device Story

Device monitors bladder cancer recurrence using voided urine. Process: urine centrifugation to isolate cell pellet; DNA extraction; methylation-sensitive restriction enzyme digestion (cleaves unmethylated DNA, leaves methylated DNA intact); real-time PCR amplification of 15 DNA methylation biomarkers. Software (Bladder EpiCheck) processes raw fluorescence data from ABI 7500 Fast Dx PCR instrument; removes noise; calculates EpiScore (0-100). Output: qualitative diagnosis (positive/negative) based on EpiScore threshold (60). Used in clinical settings by laboratory personnel. Benefits: non-invasive monitoring tool to supplement cystoscopy for NMIBC patients.

Clinical Evidence

Prospective multi-center study (n=449) compared Bladder EpiCheck to a gold standard (cytology/cystoscopy/pathology). Results: 78.8% accuracy, 66.7% sensitivity, 84.2% specificity. Comparison to predicate (n=352) showed non-inferiority (EpiCheck +4.82% sensitivity, -2.97% specificity). Specificity in non-bladder cancer urology patients (n=147) was 98.0%. Cross-reactivity study (n=147) in other cancer types showed 95% specificity.

Technological Characteristics

Real-time PCR assay targeting 15 DNA methylation biomarkers. Uses methylation-sensitive restriction enzymes for target differentiation. Requires ABI 7500 Fast Dx Real-Time PCR instrument. Software-based analysis (EpiScore). Kit includes DNA extraction reagents (silica membrane spin columns). Storage: -20°C for PCR reagents. Standalone PC software (no web connection).

Indications for Use

Indicated for monitoring tumor recurrence in patients previously diagnosed with Non-Muscle Invasive Bladder Cancer (NMIBC), in conjunction with cystoscopy. For prescription use in patients aged 22 and older.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

UroVysion Bladder Cancer Recurrence Kit (k013785)

Related Devices

K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST · Vysis · Jan 22, 2004
K013785 — UROVYSION BLADDER CANCER RECURRENCE KIT · Vysis · Feb 8, 2002
K994356 — IMMUNOCYT · Diagnocure, Inc. · Feb 23, 2000
P030052 — UROVYSION BLADDER CANCER KIT · Abbott Molecular · Jan 24, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 4, 2023 Nucleix Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103 Re: K203245 Trade/Device Name: Bladder EpiCheck Kit Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: MMW Dated: November 3, 2020 Received: November 3, 2020 Dear Janice Hogan: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Zivana Tezak-fragale -S Zivana Tezak Branch Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K203245 Device Name Bladder EpiCheck Kit Indications for Use (Describe) Bladder EpiCheck Kit is intended for the qualitative detection of DNA methylation patterns of 15 loci in human DNA that are associated with transitional cell carcinoma of the bladder. The test is performed on voided urine samples and run on the ABI® 7500 Fast Dx Real-Time PCR system. Bladder EpiCheck Kit is indicated for use as a non-invasive method to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with Non-Muscle Invasive Bladder Cancer. | 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.qov "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}------------------------------------------------ {4}------------------------------------------------ ## 510(k) Summary for Bladder EpiCheck Test #### 1. Submitter Nucleix, Ltd. Pekeris 3 Rehovot 7670203, Israel Contact: Eli Frydman, Ph.D. President, EMEA Email: eli@nucleix.com ### 2. Submission Correspondent - US Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2320 Philadelphia, PA 19103 Janice.hogan@hoganlovells.com ### 3. Device Identification | Name of Device: | Bladder EpiCheck® Test | |----------------------------|----------------------------------------------------| | Common or Usual Name: | Bladder EpiCheck | | Classification Name | Tumor-associated antigen immunological test system | | Classification Regulation: | 866.6010 | | Product Code: | MMW | | Device Class: | Class II | | Classification Panel: | Immunology | ### 4. Legally Marketed Predicate Device Abbott Molecular UroVysion™ Bladder Cancer Kit (K013785) {5}------------------------------------------------ #### ડ. Device Description The Bladder EpiCheck Test is a real-time PCR-based in vitro diagnostic assay intended for the qualitative detection of DNA methylation patterns associated with transitional cell carcinoma of the bladder to monitor for tumor recurrence (in conjunction with cystoscopy) in patients previously diagnosed with non-muscle invasive bladder cancer (NMIBC). The assay consists of a panel of 15 novel DNA methylation (covalent addition of methyl (CH3) groups to the C5 position of the pyrimidine ring of cytosines, typically in a CpG dinucleotide) biomarkers that were found to distinguish between patients with bladder cancer and patients without bladder cancer. The Bladder EpiCheck Test differentiates between methylated and non-methylated DNA, creating a unique platform for methylation profiling of urine specimens towards the detection of bladder cancer recurrence in patients previously diagnosed with the disease. The test is comprised of reagents for end-to-end (sample-to-answer) processing of urine samples (reagents for DNA extraction, DNA digestion, PCR amplification, and analysis software), and is performed using the Applied Biosystems® 7500 Fast Dx Real-Time PCR system. A voided urine specimen is centrifuged, and the cells (both normal and cancerous if present) are separated from the urine supernatant. DNA is then extracted from the cell pellet using the Bladder EpiCheck Extraction kit (P/N NX899090-01C). The extracted DNA is digested using a methylation-sensitive restriction enzyme mix. which cleaves DNA at specific recognition sequences if they are unmethylated. Methylated DNA is protected from enzymatic digestion and therefore remains intact. ### Real-Time PCR Amplification Using reagents provided in the Bladder EpiCheck Test kit, the digested DNA samples and test controls are mixed together with PCR primers and probe into 8 unique PCR multiplexes reactions and assayed using the ABI 7500 Fast Dx Real-Time PCR system. The panel of 15 biomarkers is amplified according to their residual levels of methylation. Real-time PCR amplification is performed in a 96-well plate, requires 2 assay-control samples (Undigested Control and No Template Control) and can test up to 10 patient samples. Each sample is analyzed in 8 wells, corresponding to a single column of the plate. In each well. 3-4 biomarkers are amplified. The panel of 15 biomarkers are used to determine whether a sample is bladder cancer positive or bladder cancer negative. In addition. 3 internal controls (Internal Reference, Digestion Control, and Digestion Control Reference) are used to verify successful digestion and amplification processes. ### Data Analysis The Bladder EpiCheck software (P/N NX899090-03C) accepts as an input (Source File) the *.SDS output file of the ABI7500 DX real-time PCR machine, and outputs for each patient's sample a qualitative diagnosis (positive/negative for recurrence of bladder cancer) based on the patient's EpiScore. The software implements the Bladder EpiCheck algorithm, which starts from the raw fluorescence data of the real-time PCR run and ends in the diagnosis (positive/negative) of each patient. The software enables the operator. {6}------------------------------------------------ who is running the test, to view and export reports of each patient, as well as to view the raw data of the real-time PCR run. The Bladder EpiCheck software is installed on a stand-alone PC: it does not require web connection. The software setup installs 3rd-partv specific templates, which contain all required data and steps for the PCR run on the ABI 7500 Dx Real-time PCR machine. The user only needs to input the sample's IDs in the third-party software and upload the output file once the PCR run is completed. The Bladder EpiCheck software then parses the source file, and translates its content to a unified internal format, Nucleix Real-time Information XML (NRIX). Once in NRIX format, the Bladder EpiCheck algorithm processes the signals, while removing background noise and anomalies, and interpolates the distinct cycle data. The algorithm identifies the sample's well location (controls and test) and validates their raw data and each calculation steps against predefined thresholds. Once the algorithm run is completed. the EpiScore and diagnosis are assigned to each sample unless an error occurred at any of the calculation steps. The software's user interface is designed to clearly correlate between the sample's location and their test results. A simple colorcoded scheme separates between negative, positive, or invalid results and from clinical samples and kit control samples (UC and NTC). Per sample view is also available to see the sample's fluorescence signals, a sigmoid-like amplification curve for each marker. The patient's qualitative results and the overall run summary report can be viewed in the software's user interface and exported as PDF file. ### Result Reporting The Bladder EpiCheck Test Kit is used to calculate the associated methylation level for each of the 15 biomarkers based on the associated Cq (Cycle of quantitation, which is the PCR cycle at which the marker's amplification curve reached a predefined signal threshold). These methylation levels are translated to marker scores that are based on reference methylation levels obtained from a large set of bladder cancer negative and positive patients. These 15 marker scores are then combined into a single number: the EpiScore, a number between 0 and 100 representing the overall methylation level of the sample at the panel biomarkers. The resulting EpiScore is then compared to a prespecified threshold; if it is above or equal to the threshold (60), the test is called "Positive"; otherwise, it is called "Negative". If the sample analysis is failed (e.g., insufficient DNA, incomplete digestion) or the analysis of the entire PCR plate failed (e.g., one of the plate controls failed), the output for the sample will be "Invalid". In some cases of failure, the sample/plate run may be repeated a second time, and in other cases the user will be instructed to collect a new sample from the patient. {7}------------------------------------------------ #### 6. Intended Use Statement Bladder EpiCheck Kit is intended for the qualitative detection of DNA methylation patterns of 15 loci in Human DNA that are associated with transitional cell carcinoma of the bladder. The test is performed on voided urine samples and run on the ABI 7500 Fast Dx Real-Time PCR system. Bladder EpiCheck Kit is indicated for use as a non-invasive method to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with nonmuscle invasive bladder cancer. ### Special conditions for Use statement(s): - For prescription use only . - . For in vitro diagnostic use ### Special instrument requirements: - Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument, SDS Software ● version 1.4 (cleared by FDA, K082562) #### 7. Comparison of Technological Characteristics with The Predicate Device Bladder EpiCheck is substantially equivalent to the Abbott Molecular UroVysion Bladder Cancer Kit (K013785). The Bladder EpiCheck test has the same general intended use as the previously cleared predicate device. Although the technological characteristics and principles of operation are different between Bladder EpiCheck and UroVysion, those changes do not raise any new questions of safety and efficacy. Both the Bladder EpiCheck test and UroVysion kit start with the same patient specimen type. | Characteristic | Predicate UroVysion Bladder Cancer Recurrence Kit (K013785) | Subject Device Bladder EpiCheck | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Similarities | | | | Indications for Use | The UroVysion Bladder Cancer Recurrence kit is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from subjects with transitional cell carcinoma of the bladder. Results from the UroVysion Bladder Cancer Recurrence Kit are intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy in | Bladder EpiCheck Kit is intended for the qualitative detection of DNA methylation patterns of 15 loci in Human DNA that are associated with transitional cell carcinoma of the bladder. The test is performed on voided urine samples and run on the ABI 7500 Fast Dx Real-Time PCR system. Bladder EpiCheck Kit is indicated for use as a non-invasive method to monitor for tumor recurrence in conjunction with cystoscopy in | Table 7.1 Similarities between the Predicate and Subject Device {8}------------------------------------------------ | | patients previously diagnosed with bladder cancer. | patients previously diagnosed with Non-Muscle Invasive Bladder Cancer. | |----------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Measurement Type | Qualitative | Same | | Specimen Type | Voided Urine | Same | | Sample Collection Method | Non-invasive collection of biological samples delivered into a non-sterile plastic collection cap/tube | Same | | Special Conditions for Use | Prescription Only | Same | Table 7.2 Differences between the Predicate and Subject Device | Characteristic | Predicate UroVysion Bladder Cancer Recurrence Kit (K013785) | Subject Device Bladder EpiCheck | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Differences | | | Principle of the Procedure | Fluorescence In situ hybridization (FISH) | Real-Time PCR Reaction (RT- PCR) | | Test Target | Chromosomal DNA | DNA Methylation Biomarkers | | Extraction and Assay Preparation | Cells recovered from urine pellets are fixed on slides. DNA is denatured to its single stranded form and subsequently allowed to hybridize with the probes. | DNA is extracted from the cell pellet recovered from urine. DNA is digested using a methylation-sensitive restriction enzyme, which cleaves DNA at its recognition sequence if it is unmethylated. | | Detection Instrument | Epi-fluorescence microscope | FDA-cleared Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument | | Assay Controls | Control slides are run concurrently with patient slides. | Controls are run concurrently with patient samples. Three controls consisting of Internal Reference Control (IR), No Template Control (NTC) and Undigested Control (UC) | {9}------------------------------------------------ ### 8. Performance Testing (Analytical) #### Precision/Reproducibility 8.1 ### Laboratory-to-Laboratory A laboratory-to-laboratory repeatability and reproducibility study was performed to assess variation of Bladder EpiCheck when performed in 3 different laboratories by 2 operators at each laboratory site over 3 non-consecutive run days using contrived human DNA samples. Six (6) contrived human DNA samples were created by blending gDNA from different sample sources (T24 cell line DNA (T24) and commercially available DNA (Cml.), representing different Bladder EpiCheck marker combinations) to represent four different EpiScore categories (Low Negative (LN), High Negative (HN), Low Positive (LP), and High Positive (HP)), including scores around the test cutoff (high negative and low positive). These 6 samples were tested in technical duplicates at 2 different inputs (Low = 4ng/PCR; High = 10ng/PCR). Overall performance characteristics (Agreement, PPA, and NPA) are shown in Tables 8.1.1, 8.1.2 and 8.1.3 below. There were no control (plate) failures (0/54); overall invalid rate was 0.2% (1/433; 95% CI 0.05%; 1.03%). | | | Bladder EpiCheck Result | | | | | | | | | | |---------------------|--------------|---------------------------|---------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------|---------------------|-----------------------------------------| | | | Timepoint (Day) | | | | Overall | | | | | | | | | 1 | | 2 | | 3 | | | | | | | Negative Samples | DNA Input | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | | T24 LN | High | 100 % (12/12) | [81.6 0%; 100%] | 100 % (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (36/36) | [93.01 %; 100%] | 1.4% (1/73) | [0.31 %; 5.91%] | | | Low | 100 % (12/12) | [81.6 0%; 100%] | 100 % (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (36/36) | [93.01 %; 100%] | | | | T24 HN | High | 100 % (12/12) | [81.6 0%; 100%] | 100 % (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (36/36) | [93.01 %; 100%] | 0 | -- | | | Low | 100 % (12/12) | [81.6 0%; 100%] | 100 % (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (36/36) | [93.01 %; 100%] | | | | Cml. HN | High | 100 % (12/12) | [81.6 0%; 100%] | 91.7 % (11/12) | [69.88 %; 98.12%] | 100% (12/12) | [81.60 %; 100%] | 97.2% (35/36) | [88.46 %; 99.38%] | 0 | -- | | | Low | 100 % (12/12) | [81.6 0%; 100%] | 83.3 % (10/12) | [60.08 %; 94.32%] | 100% (12/12) | [81.60 %; 100%] | 94.4% (34/36) | [84.53 %; 98.14%] | | | | | | 12) | | 12) | %] | | | | %] | | | | All Negatives | | 100 % (72/ 72) | 196.3 8%; 100% | ૭5.8 % (69) 72) | [90.02 %; 95.83 %] | 100% (72/7 2) | 196.38 %: 100%] | 98.6% (213/2 16) | 196.58 %: 99.44 %] | 0.5% (1/21 7) | [0.10 %; 2.04 %] | | Positive | | PPA | | PPA | | PPA | | PPA | | Invalid Rate | | | Sample S | DNA Input | % (n/ N) | 95% CI | % (n/ N) | તે જેને જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલ CI | 0/0 (n/N) | તે તે જેન્જી જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવ CI | 0/0 (n/N) | તે તે જેની જેવી જેવી સવલતો પ્રાપ્ CI | % (n/N ) | તે તે જેની જેવી જેવી સવલતો પ્રાપ્ CI | | | High | 100 % (12/ 12) | [96.3 8%: 100% | 100 % (12/ 12) | [81.60 %: 100%] | 100% (12/1 2) | [81.60 %: 100%] | 100% (36/36 ) | [93.01 %; 100%] | | | | T24 LP | Low | 100 % (12/ 12) | 196.3 8%; 100% | 100 % (12/ 12) | [81.60 %: 100%] | 100% (12/1 2) | [81.60 %: 100%] | 100% (36/36 ) | [93.01 %; 100%] | 0 | | | | High | 100 % (12/ 12) | 196.3 8%: 100% | 100 % (12/ 12) | [81.60 %; 100%] | 100% (12/1 2) | 81.60 %; 100%] | 100% (36/36 ) | [93.01 %; 100%] | 0 | -- | | T24 HP | Low | 100 % (12/ 12) | 196.38 %: 100% | 100 % (12/ 12) | 81.60 %; 100%] | 100% (12/12 ) | [81.60 %: 100%] | 100% (36/36) | [93.01 %: 100%] | | | | Cml. LP | High | 100 % (12/ 12) | 196.38 %; 100% | 100 % (12/ 12) | 81.60 %: 100%] | 100% (12/12 ) | [81.60 %: 100%] | 100% (36/36) | [93.01 %: 100%] | 0 | | | | Low | 100 % (12/ 12) | 196.38 %: 100% | 100 0/0 (12/ 12) | 81.60 %: 100%] | 100% (12/12 ) | [81.60 %: 100%] | 100% (36/36) | [93.01 %: 100%] | | | | All Positives | | 100 % (72/ 72) | 196.38 %; 100% | 100 0/0 (72/ 72) | 196.38 %; 100%] | 100% (72/72 ) | 196.38 %: 100%] | 100% (216/2 16) | 198.76 %; 100%] | 0 | | | All Samples | | | Agreement | | Agreement | | Agreement | Agreement | | | Invalid Rate | | | | 0/0 (n/ N) | તે જેન્જીન CI | 0% (n/ N) | તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લ CI | 0/0 (n/N) | વેરી જેવી જેવી સવલતો પ્ CI | 0/0 (n/N) | તે જેન્જી જેવી સવલતો પ્રાપ્ CI | 0/0 (n/N œ | તે તે જેન્જી જેવી સવલતો પ્રાપ્ CI | | Overall | | 100 % (144/ 144) | [98.16 %; 100% ] | 97.9 % (141 /144 | [97.92 %; 99.16 %] | 100% (144/1 44) | [98.16 %; 100%] | 99.3% (429/4 32) | 198.28 0% 99.72 %] | 0.2% (1/43 3) | [0.05 %; 1.03 %] | Table 8.1.1 Interlaboratory Reproducibility per Sample Presented as Overall and by Dav {10}------------------------------------------------ | Table 8.1.2 Interlaboratory Reproducibility per Sample Presented as Overall and by | | |------------------------------------------------------------------------------------|--| | Operator | | | Bladder EpiCheck Result | | | | | | | | |---------------------------------------|--------------------------------|--------------------------------|--------------------------------|--------------------------------|--------------------------------|--------------------------------|--------------------------------| | Operator | | | | | | Overall | | | | 1 | 2 | 3 | 4 | 5 | 6 | | | Nega tive Sam ples/ Input | NPA % (n/N) 95% CI | NPA % (n/N) 95% CI | NPA % (n/N) 95% CI | NPA % (n/N) 95% CI | NPA % (n/N) 95% CI | NPA % (n/N) 95% CI | NPA % (n/N) 95% CI | {11}------------------------------------------------ | T24 LN High | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [93.0%; 100% (36/36)] | | | | | | | | | | | | | | |----------------------------------|------------------|--------------------------------|------------------|--------------------------------|-----------------------|--------------------------------|------------------|--------------------------------|-----------------------------|--------------------------------|-----------------------------|-----------------------------|---------------------------------|------|----|---------|----|------|----|---------|----|------|-------|---------|----|---------| | T24 LN Low | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [93.0%; 100% (36/36)] | | | | | | | | | | | | | | | T24 HN High | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [93.0%; 100% (36/36)] | | | | | | | | | | | | | | | T24 HN Low | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [93.0%; 100% (36/36)] | | | | | | | | | | | | | | | Cml. HN Low | 100% (6/6) | [68.9%; 100%] | 83.3% (5/6) | [49.8%; 96.19%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [88.5%; 99.38% (35/36)] | | | | | | | | | | | | | | | Cml. HN Low | 100% (6/6) | [68.9%; 100%] | 66.7% (4/6) | [34.7%; 88.27%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [84.5%; 98.14% (34/36)] | | | | | | | | | | | | | | | All Neg | 100% (36/36) | [93.0%; 100%] | 91.7% (33/36) | [80.9%; 96.62%] | 100% (36/36) | [93.0%; 100%] | 100% (36/36) | [93.0%; 100%] | 100% (36/36) | [93.0%; 100%] | 100% (36/36) | [93.0%; 100%] | [96.6%; 99.44% (213/216)] | | | | | | | | | | | | | | | Posit ive Sample/ Input | | PPA % (n/ CI N) | | PPA % (n/ CI N) | | PPA % (n/ CI N) | | PPA % (n/ CI N) | PPA % (n/ CI N) | | PPA % (n/ CI N) | PPA % (n/ CI N) | | | | | | | | | | | | | | | | T24 LP High | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [93.0%; 100% (36/36)] | | | | | | | | | | | | | | | T24 LP Low | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [93.0%; 100% (36/36)] | | | | | | | | | | | | | | | T24 HP High | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [93.0%; 100% (36/36)] | | | | | | | | | | | | | | | T24 HP Low | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | 100% (6/6) | [68.9%; 100%] | [93.0%; 100% (36/36)] | | | | | | | | | | | | | | | Cml. LP | Input | 100% | N) | [68.9%; | CI | 100% | N) | [68.9%; | CI | 100% | N) | [68.9%; | CI | 100% | N) | [68.9%; | CI | 100% | N) | [68.9%; | CI | 100% | (n/N) | [68.9%; | CI | [93.0%; | | T24 LP High | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100% (36/36) | [93.0 % 100 %] | | | | | | | | | | | | | | | | T24 LP Low | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100% (36/36) | [93.0 % 100 %] | | | | | | | | | | | | | | | | T24 HP High | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100% (36/36) | [93.0 % 100 %] | | | | | | | | | | | | | | | | T24 HP Low | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100 (6/6 ) | [68.9 % 100 %] | 100% (36/36) | [93.0 % 100 %] | | | | | | | | | | | | | | | | Cml. LP High | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100% (36/36) | [93.0 % 100 %] | | | | | | | | | | | | | | | | Cml. HP Low | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100 (6/6 ) | [68.9 % 2%; 100 %] | 100% (36/36) | [93.0 % 100 %] | | | | | | | | | | | | | | | | All Pos | 100 (36/36) | [93.0 % 100 %] | 100 (36/36) | [93.0 % 100 %] | 100 (36/36) | [93.0 % 100 %] | 100 (36/36) | [93.0 % 100 %] | 100 (36/36) | [93.0 % 100 %] | 100% (216/216) | [98.8 % 100 %] | | | | | | | | | | | | | | | | All Samples | | Agreement % (n/ | 95% CI | | Agreement % (n/ | 95% CI | | Agreement % (n/ | 95% CI | | Agreement % (n/N) | 95% CI | | | | | | | | | | | | | | | {12}------------------------------------------------ | N) | N) | N) | N) | N) | N) | | | | | | | | | | |---------|-----------------|------------------|------------------|--------------------|-----------------|------------------|-----------------|-------------------|-----------------|------------------|-----------------|------------------|--------------------|--------------------| | Overall | 100% (72/72) | [96.4%; 100%] | 95.8% (69/72) | [90.0%; 95.83%] | 100% (72/72) | [96.4%; 100%] | 100% (72/72) | [96.4%; 72/72] | 100% (72/72) | [96.4%; 100%] | 100% (72/72) | [96.4%; 100%] | 99.3% (429/432) | [98.3%; 99.72%] | Table 8.1.3 Interlaboratory Reproducibility per Sample Presented as Overall and by Laboratory | | | Bladder EpiCheck Result | | | | | | Overall | | |-----------------------------|----------------------|-------------------------|-----------------------------|-----------------|-------------------------------|-----------------|-------------------------------|--------------------|---------------------------------| | | | Laboratory | | | | | | | | | | | 1 | 2 | 3 | | | | | | | Negati ve Sampl es | DN A Inp ut | NPA | | NPA | | NPA | | NPA | | | | | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | | T24 LN | High | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (36/36) | [93.01 %; 100%] | | | Low | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (36/36) | [93.01 %; 100%] | | T24 HN | High | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (36/36) | [93.01 %; 100%] | | | Low | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81.60 %; 100%] | 100% (36/36) | [93. 01% 100 %] | | Cml. HN | High | 91.7% (11/12) | [69.88 %; 98.12% ] | 100% (12/12) | [81.60 %; 100 %] | 100% (12/12) | [81.60 %; 100 %] | 97.2% (35/36) | [88. 46% ; 99.3 8%] | | | Low | 83.3% (10/12) | [60.08 %; 94.32% ] | 100% (12/12) | [81.60 %; 100 %] | 100% (12/12) | [81.60 %; 100 %] | 94.4% (34/36) | [84. 53% ; 98.1 4%] | | All Negatives | | 95.8% (69/72) | [90.02 %; 95.83% ] | 100% (72/72) | [96. 38% ; 100 %] | 100% (72/72) | [96. 38% ; 100 %] | 98.6% (213/216) | [96. 58% ; 99.4 4%] | | Positiv e Sampl es | DN A Inp ut | PPA | | PPA | | PPA | | PPA | | | | | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | | T24 LP | High | 100% (12/12) | [81.60 %; 100%] | 100% (12/12) | [81. 60% 100%] | 100% (12/12) | [81. 60% 100%] | 100% (36/36) | [93. 01% ; | {13}------------------------------------------------ | | | | | | 100% | | 100% | | 100% | |---------------|------|----------------------|---------------------|----------------------|-------------------|----------------------|-------------------|----------------------|---------------------| | | Low | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (36/36) | [93.01%; 100%] | | T24 HP | High | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (36/36) | [93.01%; 100%] | | | Low | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (36/36) | [93.01%; 100%] | | Cml. LP | High | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (36/36) | [93.01%; 100%] | | | Low | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (12/12) | [81.60%; 100%] | 100% (36/36) | [93.01%; 100%] | | All Positives | | 100% (72/72) | [96.38%; 100%] | 100% (72/72) | [96.38%; 100%] | 100% (72/72) | [96.38%; 100%] | 100% (216/216) | [98.76%; 100%] | | | | | | | | | | | | | All Samples | | Agreement % (n/N) | 95% CI | Agreement % (n/N) | 95% CI | Agreement % (n/N) | 95% CI | Agreement % (n/N) | 95% CI | | Overall | | 97.9% (141/144) | [97.92%; 99.16%] | 100% (144/144) | [98.16%; 100%] | 100% (144/144) | [98.16%; 100%] | 99.3% (429/432) | [98.28%; 99.72%] | An additional laboratory-to-laboratory reproducibility study, using clinical samples, was performed at 3 laboratories to determine precision between laboratories. The four (4) clinical samples used represent Low Negative (LN; ES ~20), High Negative (HN; ES~45), Low Positive (HP; ES~75), and High Positive (HP; ES~90) at 2 DNA input levels. One operator ran the test at each laboratory location on 3 different, non-consecutive workdays with an interval of at least 3 days between runs. A single reagent lot was used for this study. Overall performance characteristics (agreement, PPA, and NPA) are described in Tables 8.1.4 and 8.1.5 below. There were no control (plate) failures (0/18). Table 8.1.4 Interlaboratory Reproducibility per Sample Presented as Overall and by Day | | Bladder EpiCheck Result | | |--|-------------------------|---------| | | Laboratory | Overall | {14}------------------------------------------------ | | | | 1 | 2 | | 3 | | | | |--------------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------|-----------------------------|------------------|-----------------------------|--------------------|-----------------------------| | | | | NPA | NPA | | | NPA | | NPA | | Negative Sample | DNA Input | % (n/N | 90% CI | 0/0 (n/N) | 90% CI | 0/0 (n/N) | 90% CI | 0/0 (n/N) | 90% CI | | LN | High | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %; 100%] | 100% (18/18) | [91.64 %; 100%] | | | Low | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | 178.51 %; 100%] | 100% (6/6) | 178.51 %: 100% | 100% (18/18) | [91.64 %; 100%] | | HN | High | 100% (6/6) | [78.51 %; 100%] | 83.3% (5/6) | [57.47 %; 94.87 %] | 83.3% (5/6) | [57.47 %: 94.87 %] | 88.9% (16/18) | 175.99 %: 95.29 %] | | | Low | 66.7 % (4/6) | [40.94 %; 85.23 %] | 100% (6/6) | 178.51 %; 100%] | 83.3% (5/6) | [57.47 %; 94.87 %] | 83.3% (15/18) | [69.42 %: 91.68 %] | | All Negatives | | 91.7 % (22/2 4) | 175.1 %: 98.2% | 95.8% (23/24) | [80.4 %: 99.7% - | 91.7% (22/24) | [75.1 %; 98.2% | 93.1% (67/72) | 88.2 %; 96.0% | | | | PPA | | PPA | | PPA | | PPA | | | Positive Sample | DNA Input | % n/N | 90% CI | 0/0 (n/N) | 90% CI | 0/0 (n/N) | 90% CI | 0/0 (n/N) | 90% CI | | LP | High | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %; 100% | 100% (18/18) | [91.64 %; 100%1 | | | Low | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | 178.51 %; 100%] | 100% (18/18) | [91.64 %: 100%] | | Hb | High | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %: 100%] | 100% (18/18) | [91.64 %: 100%] | | | Low | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %; 100%] | 100% (6/6) | [78.51 %: 100% | 100% (18/18) | [91.64 %: 100%1 | | All Positives | | 100% (24/2 4) | 186.4 %; 100% | 100% (24/24) | 186.4 %; 100% | 100% (24/24) | [86.4 %: 100% | 100% (72/72) | [97.8 %; 100%7 | | | | | Agreement | Agreement | | Agreement | | Agreement | | | All Samples | | % (n/N ) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | | Overall | | તે જેવી જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામ % (46/4 8) | [90.4 %; 98.3% | 97.9% (47/48) | [93.3 %; 99.4% 1 | 95.8% (46/48) | [90.4 %; 98.3% | 96.5% (139/144) | [94.0 %; 98.0% | Table 8.1.5 Interlaboratory Reproducibility per Sample Presented as Overall and by Day | Bladder EpiCheck Result | | | | |-------------------------|-----------------|---|---------| | | Timepoint (Day) | | | | 1 | 2 | 3 | Overall | {15}------------------------------------------------ | Negative | DNA Input | NPA | | NPA | | NPA | | NPA | | Invalid Rate | | |---------------|-----------|--------------|----------------|---------------|------------------|---------------|------------------|-----------------|------------------|--------------|---------------| | Sample | | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | | LN | High | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (18/18) | [91.64%; 100%] | 0 | -- | | | Low | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (18/18) | [91.64%; 100%] | | | | HN | High | 100% (6/6) | [78.51%; 100%] | 66.7% (4/6) | [40.94%; 85.23%] | 100% (6/6) | [78.51%; 100%] | 88.9% (16/18) | [75.99%; 95.29%] | 5.3% (2/38) | [2.2%; 12.0%] | | | Low | 100% (4/4) | [70.89%; 100%] | 75% (6/8) | [52.37%; 89.11%] | 83.3% (5/6) | [57.47%; 94.87%] | 83.3% (15/18) | [69.42%; 91.68%] | | | | All Negatives | | 100% (22/22) | [85.3%; 100%] | 84.6% (22/26) | [67.6%; 94.1%] | 95.8% (23/24) | [80.4%; 99.7%] | 93.1% (67/72) | [88.2%; 96.0%] | 2.7% (2/74) | [1.1%; 6.3%] | | Positive | DNA Input | PPA | | PPA | | PPA | | PPA | | Invalid Rate | | | Sample | | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | | LP | High | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (18/18) | [91.64%; 100%] | 0 | -- | | | Low | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (18/18) | [91.64%; 100%] | | | | HP | High | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (6/6) | [78.51%; 100%] | 100% (18/18) | [91.64%; 100%] | 2.7% (1/37) | [0.8%; 8.6%] | | | Low | 100% (6/6) | [78.51%; 100%] | 100% (5/5) | [75.27%; 100%] | 100% (7/7) | [81.00%; 100%] | 100% (18/18) | [91.64%; 100%] | | | | All Positives | | 100% (24/24) | [86.4%; 100%] | 100% (23/23) | [85.9%; 100%] | 100% (25/25) | [86.9%; 100%] | 100% (72/72) | [97.8%; 100%] | 1.4% (1/73) | [0.4%; 4.5%] | | All Samples | | | Agreement | | Agreement | | Agreement | | Invalid Rate | | | | | | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | % (n/N) | 90% CI | | Overall | | 100% | [96.6%; | 91.8% | [85.4%; | 98.0% (48/49) | [93.4%; | 96.5% (139/144) | [94.0%; 98.0%] | 2.0% (3/14) | [1.0%; | {16}------------------------------------------------ | | | | | 00 | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--|-----| | 40/ | 100 | . J/G | ﺮ 1 ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | 1.7 | | 4.1 | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 11 46 | 0/01 | Al | 0/01 | %1 | | %1 | ### Operator-to-Operator/Day-to-Day An operator-to-operator and day-to-day repeatability and reproducibility study was performed to assess the within-run, between-run, and between-operator variation of Bladder EpiCheck when performed by different operators over 5 non-consecutive days. Healthy donor urine pools were spiked with bladder cancer-derived cell line material at different input levels to formulate 4 test samples spanning the measurable range of EpiScore values. Overall performance characteristics (agreement, PPA, and NPA) are summarized in Tables 8.1.6, 8.1.7, and 8.1.8 below. There were no invalid results and 1 control (plate) failure out of 21 plates (1/21 = 4.8% [95% CI 1.1%; 18.8%]. | Sample Category | Bladder EpiCheck Result Timepoint (Day) | | | | | Overall | |--------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-----------------------------------------------------| | | 1 | 2 | 3 | 4 | 5 | | | Negative Sample | NPA | NPA | NPA | NPA | NPA | NPA | | | % (n/ N) CI | % (n/ N) CI | % (n/ N) CI | % (n/ N) CI | % (n/ N) CI | % (n/N ) 95% CI | | LN | 100 % [78.7%; (10/ 10) 100%] | 100 % [78.7%; (10/ 10) 100%] | 100 % [78.7%; (10/ 10) 100%] | 100 % [78.7%; (10/ 10) 100%] | 100 % [78.7%; (10/ 10) 100%] | 100 % (50/5 0) [94.9%; 100%] | | HN | 100 % [78.7%; (10/ 10) 100%] | 100 % [78.7%; (10/ 10) 100%] | 90 % [59.5%; (9/10) 99.3%] | 100 % [78.7%; (10/ 10) 100%] | 100 % [78.7%; (10/ 10) 100%] | 98% (49/5 0) [91.5%; 99.6%] | | All Negatives | 100 % [83.9%; (20/ 20) 100%] | 100 % [83.9%; (20/ 20) 100%] | 95 % [76.4%; (19/ 20) 99.1%] | 100 % [83.9%; (20/ 20) 100%] | 100 % [83.9%; (20/ 20) 100%] | 99% (99/1 00) [94.6%; 99.8%] | | Positive Sa…

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

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Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

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