(83 days)
Not Found
No
The device description and performance studies focus on standard PCR technology and do not mention any AI or ML components.
No.
The device is an in vitro diagnostic test intended to aid in the diagnosis of anogenital HSV-1 and HSV-2 infections, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an automated, qualitative in vitro diagnostic test" and "is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients."
No
The device is an in vitro diagnostic test that utilizes real-time PCR and involves automated sample preparation, reagent kits, and a system (cobas® 4800 system), indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test..."
N/A
Intended Use / Indications for Use
The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years.
Product codes (comma separated list FDA assigned to the subject device)
OQO
Device Description
The Roche Molecular Systems (RMS) cobas® HSV 1 and 2 Test utilizes real-time polymerase chain reaction (PCR) for detection of HSV-1 and HSV-2 DNA in clinician-collected external anogenital lesion specimens, collected in MSwab medium from symptomatic patients.
The cobas® HSV 1 and HSV 2 Test contains two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process.
The MSwab Collection. Transport and Preservation System (Copan Flock Technologies) is used for specimen collection, transportation and storage of specimen for the cobas " HSV 1 and HSV 2 Test.
The cobas® HSV 1 and HSV 2 Test utilizes six reagent kits:
- cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 1)
- cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 2)
- cobas® 4800 System Wash Buffer Kit 3)
- cobas® 4800 System Lysis Kit 1 4)
- cobas® 4800 System Internal Control Kit 1 5)
- cobas® 4800 System Sample Preparation Kit 6)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external anogenital lesion
Indicated Patient Age Range
18 years and older (inferential based on the warning "not intended to be used for individuals under the age of 18 years.")
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Evaluation
- Analytical sensitivity (Limit of Detection): Determined by analyzing quantified HSV-1 and HSV-2 viral cultures diluted at multiple concentration levels into a simulated anogenital lesion swab matrix. All levels tested with at least 21 replicates using the full cobas® HSV 1 and 2 Test workflow across five lots of reagents. LOD is defined as the target concentration detected as positive in >= 95% of replicates. HSV-1 MacIntyre strain LOD: 0.479 TCID50/mL. HSV-2 G strain LOD: 0.112 TCID50/mL.
- Analytical Inclusivity: Four HSV-1 strains and three HSV-2 strains were tested in 40 replicates near the LoD. All strains were detected, demonstrating detection of a broad range of isolates.
- Precision: In-house study with HSV-1 and HSV-2 viruses diluted below LOD, near LOD, and above LOD in a simulated anogenital swab matrix. A negative level was also tested. The study used three unique lots of reagents and three instruments for 36 runs over 12 days. Overall CV (%) of Ct values for positive panel members at above LOD concentrations were 2.2% for HSV-1 Ct and 1.9% for HSV-2 Ct.
- Competitive inhibition: Panels constructed with HSV-1 at ~3 x LOD and competing HSV-2 at ~300 x LOD, and vice versa. No effect on detection was observed.
- Analytical specificity/Cross-reactivity and Microbial Panel: Assessed by testing a panel of 71 bacteria, fungi, and viruses, human cells, and high titer HSV-1 or HSV-2. No false positive results were produced. No interference with HSV-1 and HSV-2 target detection was observed.
- Interference: Twenty commonly used OTC products and anti-viral medications, as well as whole blood, human serum albumin, urine, feces, and mucin, were tested. HSV-1 and HSV-2 were spiked to ~3 x LOD. No interference was observed for OTC products except Vagisil Crème at 10 mg and above. Limits of no interference were established for other substances (e.g., whole blood up to 40% swab capacity, mucin up to 4.8 mg/swab).
- Reproducibility: Multi-site investigation using contrived clinical samples evaluated across lot, site/instrument, operator, day, and run. HSV test panels prepared by spiking HSV-1 and/or HSV-2 into contrived sample matrix at below LOD, 1 x LOD, and 3 x LOD, plus negative panel members. 6 members per test panel with 3 replicates per panel member included in each run. Tested at 3 sites by 2 operators per site with 1 valid run per operator per day, for 6 days per lot over 2 lots for a total of 1,296 valid tests.
- HSV-1 Reproducibility: Positive percent agreement for "Below LOD (HSV-1/HSV-2)" was 63.4% (95% CI: 56.6% to 69.9%). Positive percent agreement for all other positive panel members was 100.0% (95% CI: 98.3% to 100.0%). Negative percent agreement was 99.8% (95% CI: 98.7% to 100.0%). Total SD
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a cape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2015
ROCHE MOLECULAR SYSTEMS, INC. DAVID W. GATES, PH.D. SENIOR DIRECTOR, REGULATORY AFFAIRS 4300 HACIENDA DRIVE PLEASANTON, CA 94588-2722
Re: K150617
Trade/Device Name: cobas® HSV 1 and 2 Test Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes Simplex Virus Nucleic Acid Amplification Assay Regulatory Class: II Product Code: 000 Dated: March 9, 2015 Received: March 10, 2015
Dear Dr. Gates:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Stephen J. Lovell -S for
Sally A. Hojvat, M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150617
Device Name cobas® HSV 1 and 2 Test
Indications for Use (Describe)
The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
Box warning:
Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years.
| 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)
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cobas® HSV 1 and 2 Test 510(k) Summary
| Submitter Name | Roche Molecular Systems, Inc. |
|---|---|
| Address | 4300 Hacienda Drive |
| Pleasanton, CA 94588-2722 | |
| Contact | David Gates |
| Phone: 925.730-8237 | |
| Date Prepared | February 27, 2015 |
| Proprietary Name | cobas® HSV 1 and 2 Test |
| Common Name | HSV 1 and 2 Test |
| Regulation | 21 CFR 866.3305 |
| Classification | Class II |
| Product Code | OQO: Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Predicate Devices | BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx |
| Amplified DNA Assays (K103798) | |
| Establishment | |
| Registration | Branchburg: 2243471 |
| Pleasanton: 3004141078 | |
| Indianapolis: 1823260 |
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1. DEVICE DESCRIPTION
The Roche Molecular Systems (RMS) cobas® HSV 1 and 2 Test utilizes real-time polymerase chain reaction (PCR) for detection of HSV-1 and HSV-2 DNA in clinician-collected external anogenital lesion specimens, collected in MSwab medium from symptomatic patients.
The cobas® HSV 1 and HSV 2 Test contains two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process.
The MSwab Collection. Transport and Preservation System (Copan Flock Technologies) is used for specimen collection, transportation and storage of specimen for the cobas " HSV 1 and HSV 2 Test.
The cobas® HSV 1 and HSV 2 Test utilizes six reagent kits:
- cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 1)
- cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 2)
- cobas® 4800 System Wash Buffer Kit 3)
- cobas® 4800 System Lysis Kit 1 4)
- cobas® 4800 System Internal Control Kit 1 5)
- cobas® 4800 System Sample Preparation Kit 6)
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Test Principle
Target Selection: The cobas® HSV 1and 2 Test utilizes real-time PCR technology to detect the conserved regions of HSV-1 Thymidine Kinase and HSV-1 DNA Polymerase as well as HSV-2 Thymidine Kinase and HSV-2 Glycoprotein B genes. Fluorogenic target-specific probes are used for the detection of the amplified HSV-1 and HSV-2 DNA as well as Internal Control. Since two HSV type targets are detected with different fluorescent dyes, the cobas® HSV 1 and 2 Test has the ability to simultaneously detect and differentiate HSV-1 and HSV-2. Primer and probe oligonucleotide sequences were designed to select HSV-1 and HSV-2 conserved sequences without cross reacting to other viruses, or other bacterial organisms commonly found in human genital areas.
Sample Preparation: Sample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas x 480 instrument. Organisms from swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. They are washed and then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix.
PCR Amplification and TaqMan® Detection: The PCR cycling steps and detection of target signal occurs in the cobas 2 480 Analyzer. The Master Mix reagent contains primer pairs and probes for HSV-1, HSV-2 and IC targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher suppresses the fluorescence of the dye. However, if the PCR product is present, the probe hybridizes to the product and gets cleaved by the 5' to 3' nuclease activity of the polymerase. This reaction allows the fluorescence to be emitted from the dye, and the signal is recorded in real time during each PCR cycle by the cobas 2 480 analyzer. The signal is interpreted by the cobas® 4800 System Software and reported as final results.
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Assay Controls
RMS provides Negative Control (NC), Positive Control (PC) and Internal Control (IC) as reagent components in the cobas® HSV 1 and 2 Test
- NC contains a buffer solution. The NC is processed in each run that contains a batch . of HSV specimens and should invalidate the run if there is contamination during the assay process that results in a positive signal in any of the assay target detection channels and/or if internal control signal is negative or invalid.
- PC contains one plasmid that contains the HSV-1 target sequence, and a second plasmid that contains the HSV-2 target sequence, in the same buffer as NC. One PC is processed in each run that contains a batch of HSV specimens. The PC monitors the overall reagent and process integrity and will invalidate the run if results are outside of allowable ranges in the assay target detection channels and/or internal control signal is negative or invalid.
- IC contains recombinant lambda phage with a generic DNA sequence, which is . amplified and detected along with HSV-1 and 2 targets but uses specific primers and probe that are different from the HSV-1 and 2 sequences. Since the IC DNA is contained in the phage capsule, it acts both as a specimen lysis control and as a control for PCR inhibition. The IC is added to all specimens, PC and NC in a run.
cobas® 4800 System Description
The cobas® 4800 System is a diagnostic system designed for sample preparation and real time amplification and detection of nucleic acid targets from clinical samples. The system hardware is unchanged from that originally approved for IVD use in PMA P100020 (cobas® HPV Test, April 19, 2011). The software version has been updated to software release 2.1 in order to support the expanded test menu. The updated software was cleared for the current tests on the cobas® 4800 system per Special 510(k) (K140887).
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2. INTENDED USE
The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in cliniciancollected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years.
3. TECHNOLOGICAL CHARACTERISTICS
The RMS cobas® HSV 1 and 2 Test is substantially equivalent in terms of its technological characteristics to the currently legally marketed predicate device, the BD ProbeTec "" Herpes Simplex Viruses (HSV 1 & 2) Q* Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798).
Differences reside in the amplification technology. Although the candidate test utilizes real-time PCR while the predicate uses strand displacement, both methods are using the same basic principle to amplify low copies of nucleic acids to amounts which can subsequently be detected.
| Similarities | ||
|---|---|---|
| Characteristic | BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) | Roche cobas® HSV 1 and 2 Test New Device (K150617) |
| Intended use | The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper™ System in Extracted Mode, use Strand | The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection |
| Displacement | ||
| Amplification | ||
| technology for the direct, qualitative | ||
| detection and differentiation of Herpes | ||
| Simplex virus type 1 (HSV1) and | ||
| Herpes Simplex virus type 2 (HSV2) | ||
| DNA in clinician-collected external | ||
| anogenital lesion specimens. The | ||
| assays are indicated for use with | ||
| symptomatic individuals to aid in the | ||
| diagnosis of anogenital HSV1 and | ||
| HSV2 infections. | ||
| Warning: The BD ProbeTec™ Herpes | ||
| Simplex Viruses (HSV 1 & 2) Qx | ||
| Amplified DNA Assays (HSV Qx | ||
| Assays) are not FDA cleared for use | ||
| with cerebrospinal fluid (CSF). The | ||
| assays are not intended to be used for | ||
| prenatal screening or for individuals | ||
| under the age of 17 years. | Amplification and differentiation of Herpes simplex | |
| virus 1 and 2 (HSV-1 and HSV-2) DNA | ||
| in clinician-collected anogenital lesion | ||
| specimens from symptomatic male and | ||
| female patients. The cobas® HSV 1 and | ||
| 2 Test is intended for use as an aid in | ||
| diagnosis of anogenital HSV-1 and | ||
| HSV-2 infections in symptomatic | ||
| patients. | ||
| Warning: The cobas® HSV 1 and 2 | ||
| Test is not FDA cleared for use with | ||
| cerebrospinal fluid (CSF) and is not | ||
| intended to be used for prenatal | ||
| screening or for individuals under the | ||
| age of 18 years. | ||
| Sample Types | External anogenital lesions | Same |
| Assay Results | Qualitative detection and | |
| differentiation of HSV-1 and HSV-2 | ||
| DNA | Same | |
| Detection | ||
| Chemistry | Paired reporter and quencher | |
| fluorescence labeled probes using | ||
| fluorescence resonance energy | ||
| transfer (FRET) | Same | |
| Differences | ||
| Characteristic | BD ProbeTec™ Herpes Simplex | |
| Viruses (HSV 1 & 2) Qx Amplified | ||
| DNA Assays on the BD Viper | ||
| System in Extracted Mode, | ||
| (K103798) | Roche cobas® HSV 1 and 2 Test | |
| New Device (K150617) | ||
| Amplification | ||
| Technology | Strand Displacement Amplification | Real-time PCR |
| Sample | ||
| Preparation | ||
| Procedure | Automated on BD™™ Viper™™ | |
| System in Extracted Mode | Automated on cobas® 4800 System |
Similarities and Differences Between the cobas® HSV 1 and 2 Test and the Table 1: Predicate Device
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NON-CLINICAL PERFORMANCE EVALUATION 4.
Analytical sensitivity (Limit of Detection)
The analytical sensitivity (Limit of Detection or LOD) for the cobas® HSV 1 and 2 Test was determined by analyzing quantified HSV-1 and HSV-2 viral cultures diluted at multiple concentration levels into a simulated anogenital lesion swab matrix. The simulated matrix composed of mucin and human cells and mimics the effect of the clinical anogenital background for the cobas® HSV 1 and 2 Test. All levels were tested with at least 21 replicates using the full cobas® HSV 1 and 2 Test workflow across five lots of cobas® HSV 1 and 2 Test reagents. LOD for this test is defined as the target concentration which can be detected as positive in ≥ 95% of the replicates tested, based on results generated by the worst performing lot.
HSV-1 Maclntyre and HSV-2 G strains were tested in the analytical sensitivity study. The cobas® HSV 1 and 2 Test LOD on these isolates is shown in Table 2.
| Organism | Strain | ATCC ID | LOD (TCID50 /mL) |
|---|---|---|---|
| HSV-1 | MacIntyre | VR-539 | 0.479 |
| HSV-2 | G | VR-734 | 0.112 |
Table 2: cobas® HSV 1 and 2 Test LOD (Limit of Detection)
Analytical Inclusivity
Four HSV-1 strains (VR-260. VR-733. VR-735 and VR-1493) and three HSV-2 strains (VR-1779, VR-1781 and VR-540) were tested for reactivity with the cobas® HSV 1 and 2 Test. These strains were obtained from ATCC and were cultured and quantified by Virapur, LLC (California, US). Each strain was diluted in a similar fashion as in the Limit of Detection study and was tested in 40 replicates near the LoD. All strains were detected by the assay. demonstrating that the cobas 9 HSV 1 and 2 Test can detect a broad range of both HSV-1 and HSV-2 isolates.
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Precision
An in-house precision study was conducted with HSV-1 and HSV-2 viruses diluted in a simulated anogenital swab matrix to concentration levels below Limit of Detection (LOD), near LOD and above LOD of the cobas® HSV 1 and 2 Test. A negative level composed of only the simulated anogenital swab matrix was also tested. The study used three unique lots of cobas® HSV 1 and 2 Test reagents and three instruments for a total of 36 runs over 12 days. A description of the precision panels and the study results are shown in Table 3. An analysis of the variance of the Ct values from valid tests was performed on positive panel members at above LOD concentrations. The analysis yielded overall CV (%) of 2.2% for HSV-1 Ct and 1.9% for HSV-2 Ct (see Table 4 and Table 5).
| Panel
| Member | Concentration | HSV-1 (N=72) | HSV-2 (N=72) | |||||
|---|---|---|---|---|---|---|---|---|
| HSV-1 | HSV-2 | Positive | ||||||
| Results | Hit | |||||||
| rate | 95% 2- | |||||||
| Sided CI | Positive | |||||||
| Results | Hit | |||||||
| rate | 95% 2- | |||||||
| Sided CI | ||||||||
| P1 | Negative | Negative | 0 | 0% | 0 - 5% | 0 | 0% | 0 - 5% |
| P2 |