(94 days)
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No
The summary describes a standard in vitro diagnostic immunoassay for detecting antibodies and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for the qualitative determination of antibodies, aiding in the presumptive diagnosis of HSV infection. It does not provide any treatment or therapeutic benefit to the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use" and is indicated for "aiding in the presumptive diagnosis of HSV infection."
No
The device is an in vitro diagnostic assay (ADVIA Centaur® Herpes-1 IgG assay) used on the ADVIA Centaur systems, which are hardware platforms. The 510(k) summary describes the performance of the assay itself, not a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ADVIA Centaur® Herpes-1 IgG (HSV1) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma..."
This statement clearly indicates that the device is intended to be used outside of the body to examine specimens (serum and plasma) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® Herpes-1 IgG (HSV1) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive or negative result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 infection.
The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatic patients or matrices other than human serum and plasma (EDTA and lithium heparin).
Product codes (comma separated list FDA assigned to the subject device)
MXJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The test is indicated for testing sexually active adults or expectant mothers. The performance of this assay has not been established for pediatric patients.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A multisite clinical study was performed using a total of 864 specimens (>= 18 years of age), including specimens from 274 pregnant women. Specimens were collected within the United States and tested at 3 independent external laboratories. Samples were analyzed in singlicate. Sensitivity and specificity were determined by comparing the performance of the ADVIA Centaur HSV1 assay to a commercially available anti-HSV-1 IgG immunoblot method (Comparative Assay) and a validated Western Blot reference confirmatory test (University of Washington, Seattle). Of the 864 specimens tested by the Comparative Assay, 22 were equivocal and further tested by the Western Blot test. After Western Blot testing, 19 of the specimens were resolved to be negative and 3 remained equivocal.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study:
A precision study was performed according to CLSI EP05-A3 using the Negative and Positive Controls as well as 6 samples prepared at different levels in the assay range. Each material was tested in duplicate, twice a day for 20 days, for a total of 80 replicates per level. The results showed that the ADVIA Centaur HSV1 assay met the design requirements for repeatability and within-lab precision across various index levels. For example, for an index value of 0.57, repeatability CV was 4.8% and within-lab CV was 5.9%, which are within the ≤ 10.0% and ≤ 15.0% requirements respectively for the 0.51–0.79 range.
Sample Matrix Study:
This study was performed on one ADVIA Centaur XP instrument, using 68 sets of matched samples of different matrixes (serum, serum separator tube (SST), EDTA plasma and lithium heparin plasma) from commercial sources. The samples were analyzed in duplicate in randomized order using one reagent lot.
- Comparing Serum Separator Tube (y) vs Serum (x): (Deming regression) y = -0.01 + 0.99 x, r=0.996. Sample range for both matrixes 0.10-19.15 Index Value and 0.10-19.59 Index Value respectively.
- Comparing EDTA Plasma(y) vs Serum (x): (Deming regression) y= -0.02 + 0.96 x, r=0.998. Sample range for both matrixes 0.10-19.14 Index Value and 0.11-19.19 Index Value respectively.
- Comparing Lithium Heparin Plasma(y) vs Serum (x): (Deming regression) y= -0.02 + 0.96 x, r=0.998. Sample range for both matrixes 0.10-19.15 Index Value and 0.10-18.73 Index Value respectively.
The results support that Serum Separator Tube, EDTA Plasma, and Lithium Heparin Plasma are equivalent matrices to Serum.
Panels Study:
- Seracare Diagnostics panel: 25 characterized HSV samples. 92% total agreement with reference assay 1 using the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument.
- ToRCH-mixed Zeptometrix panel: 24 characterized HSV samples. 96% total agreement with reference assay 1 using the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument.
- CDC panel: 100 blind characterized HSV samples. 100% total agreement in concordance with results provided by the CDC using the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument.
Interferences Study:
Potential interference from various compounds (Biotin, Hemoglobin, Bilirubin complex/free, Hypoproteinemia, Hyperproteinemia, Lipemia, Cholesterol) was tested at three levels of samples (high negative, low positive, positive) with at least one reagent lot on ADVIA Centaur XP instrument. The study confirmed no interference (≤ 10% change in results) for the ADVIA Centaur Herpes-1 IgG up to the tested concentrations.
Cross-reactivity Study:
The ADVIA Centaur HSV1 assay was evaluated for potential cross-reactivity with other viral antibodies, disease-state specimens, and other populations. The HSV-1 IgG status of each specimen was verified using a Comparative Assay. Repeat equivocal specimens on the Comparative Assay were sent to a reference laboratory for Western Blot testing. Total percent agreement for 431 specimens across various clinical categories was 95.8% (413/431).
Clinical Study:
A multisite clinical study was performed with 864 specimens (≥ 18 years of age), including 274 pregnant women.
- Overall Population: The overall agreement was 97.0% (838/864) with a 95% confidence interval (CI) of 95.6%-97.9%. Sensitivity was 97.5% (507/520) with a 95% CI of 95.8%-98.5%. Specificity was 96.2% (331/344) with a 95% CI of 93.6%-97.8%.
- Pregnant Population: Sensitivity was 98.7% (155/157) with a 95% CI of 95.5%-99.7%. Specificity was 98.3% (115/117) with a 95% CI of 94.0%-99.5%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Population:
- Sensitivity: 97.5% (507/520) with a 95% confidence interval (CI) of 95.8%-98.5%.
- Specificity: 96.2% (331/344) with a 95% confidence interval (CI) of 93.6%-97.8%.
- Overall Agreement: 97.0% (838/864) with a 95% confidence interval (CI) of 95.6%-97.9%.
Pregnant Population:
- Sensitivity: 98.7% (155/157) with a 95% confidence interval of 95.5%-99.7%.
- Specificity: 98.3% (115/117) with a 95% confidence interval of 94.0%-99.5%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3305 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2018
Biokit, S.A. Joan Guixer QA & RA Director Can Male S/N Llica d'Amunt, 08186 Barcelona, Spain
Re: K181333
Trade/Device Name: ADVIA Centaur Herpes-1 IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MXJ Dated: May 17, 2018 Received: May 25, 2018
Dear Joan Guixer:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Steven R. Gitterman -S for
Uwe Scherf, 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) K181333
Device Name ADVIA Centaur Herpes-1 IgG
Indications for Use (Describe)
The ADVIA Centaur® Herpes-1 IgG (HSV1) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive or negative result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 infection.
The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatic patients or matrices other than human serum and plasma (EDTA and lithium heparin).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| 1. Submitter's Information | Biokit, S.A.
Can Malé S/N
Lliçà d'Amunt 08186
Barcelona (Spain) |
| ---------------------------- | -------------------------------------------------------------------------- |
|---|
| 2. Contact Person | Joan Guixer, QA & RA Director
Phone: +34 93 860 90 00 / +34 657 88 33 47
Email: jguixer@biokit.com |
| ------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
| 3. Preparation Date | May 17th, 2018 |
|---|---|
| --------------------- | ---------------- |
| 5. Regulatory
| Information | Regulation Number | 21 CFR 866.3305 |
|---|---|---|
| Regulation Description | Herpes simplex virus | |
| serological assays. | ||
| Classification | Class II Special Controls | |
| Product Code | MXJ | |
| Classification Panel | Microbiology |
| 6. Predicate Device | K000238 (Focus HerpeSelect 1 and 2 Immunoblot IgG) |
|---|---|
| --------------------- | ---------------------------------------------------- |
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Image /page/4/Picture/0 description: The image shows the logo for Biokit, a Werfen company. The logo consists of a stylized "W" made up of two overlapping blue shapes, followed by the word "Biokit" in gray. Below "Biokit" is the text "A Werfen Company" in a smaller, gray font.
| 7. Indications for Use /
| Intended Use | The ADVIA Centaur Herpes-1 IgG (HSV1) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. This assay is intended for use as an aid in the determination of serological status to HSV-1 and in the diagnosis of herpes simplex virus infection. |
|---|---|
| -------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| COMPARISON PREDICATE | ||
|---|---|---|
| Item | Predicate | New Device |
| Trade Names | Focus HerpeSelect 1 and 2 | |
| Immunoblot IgG | ADVIA Centaur Herpes-1 IgG | |
| 510K nº | K000238 | Pending |
| Manufacturer | Focus Diagnostic | |
| Cypress, CA 90630 -USA | Siemens Heathcare | |
| Diagnostics Inc. | ||
| 511 Benedict Avenue, | ||
| Tarrytown, NY 10591- USA | ||
| Similarities | ||
| Intended use | Focus Diagnostics HerpeSelect 1 | |
| and 2 Immunoblot IgG test is | The ADVIA Centaur Herpes-1 | |
| IgG (HSV1) assay is for in vitro | ||
| intended for qualitatively detecting | ||
| the presence or absence of human | ||
| IgG class antibodies to HSV-1 and | ||
| HSV-2 in human sera. The test is | ||
| indicated for testing sexually active | ||
| adults or expectant mothers for | ||
| aiding in the presumptive diagnosis | ||
| of HSV-1 and HSV-2 infection. The | ||
| predictive value of a positive or | ||
| negative result depends on the | ||
| population's prevalence and the | ||
| pretest likelihood of HSV- 1 and | ||
| HSV-2 infection. The performance | ||
| of this assay has not been | ||
| established for use in a pediatric | ||
| population, for neonatal screening, | ||
| for testing of | ||
| immunocompromised patients, for | ||
| use by a point of care facility or for | ||
| use with automated equipment | diagnostic use in the | |
| qualitative determination of | ||
| IgG antibodies to herpes | ||
| simplex virus type 1 (HSV-1) | ||
| in human serum and plasma | ||
| (EDTA and lithium heparin) | ||
| using the ADVIA Centaur | ||
| systems. This assay is | ||
| intended for use as an aid in | ||
| the determination of | ||
| serological status to HSV-1 | ||
| and in the diagnosis of | ||
| herpes simplex virus | ||
| infection. | ||
| Measurand | To detect the presence or absence | |
| of human IgG class antibodies to | ||
| HSV-1 and HSV-2 | To detect IgG antibodies to | |
| herpes simplex virus type 1 | ||
| (HSV-1). | ||
| Regulation Section | 21 CFR 866.3305 | Same |
| Product Code | LGC | MXJ |
| Classification | Class II Special Controls | Same |
| Assay Type | Qualitative | Same |
| Differences | ||
| Technology | Nitrocellulose immunoblot | Chemiluminescent |
| immunoassay | ||
| Sample type | Human serum | Human serum and |
| plasma (EDTA and lithium | ||
| heparin) |
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Image /page/5/Picture/0 description: The image contains the logo for Biokit, which is a Werfen company. The logo consists of a stylized "W" made up of two overlapping blue shapes, followed by the word "Biokit" in gray text. Below the word "Biokit" is the text "A Werfen Company" in a smaller font size, also in gray.
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Image /page/6/Picture/0 description: The image shows the logo for Biokit, a Werfen Company. The logo consists of a blue geometric shape resembling two overlapping chevrons, followed by the company name "Biokit" in gray text. Below the company name, the text "A Werfen Company" is written in a smaller, gray font.
9. Performance Summary
Precision
A precision study was performed according to CLSI EP05-A3 using the Negative and Positive Controls as well as 6 samples prepared at different levels in the assay range. Each material was tested in duplicate, twice a day for 20 days, for a total of 80 replicates per level.
The ADVIA Centaur HSV1 assay is designed to have the following repeatability and withinlab precision requirements:
| Design Requirement | ||
|---|---|---|
| ADVIA Centaur HSV1 Level (Index) | Repeatability | |
| % CV | Within-Lab | |
| % CV | ||
| 6.00 | ≤ 5.0% | ≤ 10.0% |
೩ NA = not applicable
The results for this study are presented below.
| Specimen Type | N | Mean
(Index) | Repeatability | | Within-Lab | |
|------------------------------|----|-----------------|---------------|--------|------------|-------|
| | | | SD | CV (%) | SD | CV(%) |
| Negative Control
(Plasma) | 80 | 0.26 | 0.01 | NAa | 0.03 | NAa |
| Positive Control
(Plasma) | 80 | 2.98 | 0.10 | 3.2 | 0.18 | 6.1 |
| Serum 1 | 80 | 0.25 | 0.03 | NAa | 0.04 | NAa |
| Serum 2 | 80 | 0.57 | 0.03 | 4.8 | 0.03 | 5.9 |
| Serum 3 | 80 | 0.97 | 0.03 | 3.1 | 0.04 | 4.5 |
| Serum 4 | 80 | 1.61 | 0.05 | 3.1 | 0.09 | 5.3 |
| Serum 5 | 80 | 4.08 | 0.20 | 4.9 | 0.26 | 6.4 |
| Serum 6 | 80 | 13.37 | 0.53 | 4.0 | 1.04 | 7.7 |
Precision results for the HSV-1 Assay
NA = Not applicable
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Image /page/7/Picture/0 description: The image shows the logo for Biokit, a Werfen company. The logo consists of a stylized "W" made up of two overlapping blue shapes, followed by the word "Biokit" in gray. Below the word "Biokit" is the text "A Werfen Company" in a smaller font size, also in gray.
Sample matrix
This study was performed on one ADVIA Centaur XP instrument, using 68 sets of matched samples of different matrixes (serum, serum separator tube (SST), EDTA plasma and lithium heparin plasma) from commercial sources
The samples were analyzed in duplicate in randomized order using one reagent lot.
- . Comparing Serum Separator Tube (y) vs Serum (x): (Deming regression) y = -0.01 + 0.99 x, r=0.996, sample range for both matrixes 0.10-19.15 Index Value and 0.10-19.59 Index Value respectively. Note – correlation coefficient is calculated using linear regression.
- . Comparing EDTA Plasma(y) vs Serum (x): (Deming regression) y= -0.02 + 0.96 x, r=0.998, sample range for both matrixes 0.10-19.14 Index Value and 0.11-19.19 Index Value respectively. Note - correlation coefficient is calculated using linear regression.
- . Comparing Lithium Heparin Plasma(y) vs Serum (x): (Deming regression) y= -0.02 + 0.96 x, r=0.998, sample range for both matrixes 0.10-19.15 Index Value and 0.10-18.73 Index Value respectively. Note - correlation coefficient is calculated using linear regression.
The results supports that Serum Separator Tube is equivalent matrix to Serum, EDTA Plasma is equivalent matrix to Serum and Lithium Heparin Plasma is an equivalent matrix to Serum.
Panels
The commercial sample panels, Seracare Diagnostics and ToRCH-mixed Zeptometrix, and CDC panel were analysed.
The Seracare Diagnostics panel included 25 characterized HSV samples. All of the samples were evaluated with the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument and 92% total agreement was observed with reference assay 1.
The ToRCH-mixed Zeptometrix panel included 24 characterized HSV samples. All of the samples were evaluated with the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument and 96% total agreement was observed with reference assay 1.
The CDC panel included 100 blind characterized HSV samples. All of the samples were evaluated with the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument and 100% total agreement was observed in concordance with the results provided by the CDC.
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Image /page/8/Picture/0 description: The image shows the logo for Biokit, a Werfen Company. The logo consists of a stylized "W" made up of two overlapping blue shapes, followed by the name "Biokit" in gray text. Below the name is the text "A Werfen Company" in a smaller font size, also in gray.
Interferences
Potential interference in the ADVIA Centaur HSV1 assay from the compounds listed below is designed to be ≤ 10%. Interfering substances at the levels indicated were tested as described in CLSI Document EP7-A2.
The testing was done in three levels of samples in the assay range (high negative, low positive and positive samples) with at least one reagent lot on ADVIA Centaur XP instrument.
Testing confirmed no interference (Demonstrate ≤ 10% change in results) for the ADVIA Centaur Herpes-1 IgG up to the following concentrations:
| Serum specimens that are... | Demonstrate ≤10% change in results up to... |
|---|---|
| Biotin | 3500 ng/mL |
| Hemoglobin | 500 mg/dL |
| Bilirubin complex | 40 mg/dL |
| Bilirubin free | 40 mg/dL |
| Hypoproteinemia | 3 g/dL |
| Hyperproteinemia | 12 g/dL |
| Lipemia | 1000 mg/dL |
| Cholesterol | 400 mg/dL |
Cross-reactivity
The ADVIA Centaur HSV1 assay was evaluated for potential cross-reactivity with other viral antibodies, disease-state specimens, and other populations. The HSV-1 lgG status of each specimen was verified using the Comparative Assay. Repeat equivocal specimens on the Comparative Assay were sent to a reference laboratory for Western Blot testing. Total percent agreement for the following clinical categories was 95.8% (413/431). The following results were obtained:
Cross Reactivity Study Performance Results
| Number | ADVIA Centaur HSV1 | Comparative Assay | ||
|---|---|---|---|---|
| Clinical Category | tested | Reactive | Positive | |
| Antibody to hepatitis B surface antigen (Anti- | ||||
| HBs) | 10 | 8 | 8 | |
| Anti-gliadin | 10 | 6 | 6 | |
| Anti-nuclear antibody (ANA) | 10 | 5 | 5 | |
| Clinical Category | Number tested | ADVIA Centaur HSV1 | ||
| Reactive | Comparative Assay | |||
| Positive | ||||
| Candida albicans | 10 | 10 | 9 | |
| Chlamydia trachomatis | 10 | 6 | 7a | |
| Cytomegalovirus (CMV IgG) | 10 | 6 | 7b | |
| Elevated IgG | 10 | 8 | 8 | |
| Elevated IgM | 10 | 9 | 10a/c | |
| Epstein-Barr virus (EBV VCA IgG) | 10 | 9 | 9 | |
| Escherichia coli | 10 | 9 | 9 | |
| Flu vaccine recipients | 10 | 3 | 3 | |
| Gardnerella vaginalis | 10 | 7 | 7 | |
| Hepatitis C virus (HCV) | 25 | 19 | 21 | |
| Hepatitis B surface antigen (HBsAg) | 10 | 9 | 9 | |
| Herpes simplex virus type 2 (HSV-2) | 74 | 35 | 33a | |
| Heterophile antibodies | 10 | 1 | 1 | |
| Human anti-mouse antibody (HAMA) | 31 | 24 | 25a | |
| Human herpes virus 6 (HHV-6) | 10 | 6 | 5 | |
| Human herpes virus 8 (HHV-8) | 10 | 9 | 9 | |
| Human immunodeficiency virus (HIV) | 10 | 10 | 10 | |
| Human Papillomavirus (HPV) | 10 | 6 | 6a | |
| Multiple myeloma | 10 | 10 | 10 | |
| Neisseria gonorrhoeae | 25 | 17 | 16 | |
| Parvovirus B19 | 10 | 4 | 4 | |
| Rheumatoid Factor (RF) | 10 | 6 | 6 | |
| Rubella IgG | 10 | 7 | 7 | |
| Syphilis | 10 | 9 | 9a | |
| Systemic lupus erythematosus (SLE) | 26 | 17 | 17 | |
| Toxoplasma IgG | 10 | 10 | 10 | |
| Varicella zoster virus (VZV) | 10 | 5 | 6a | |
| Total Specimens | 431 | 290 | 292 |
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A Werfen Company
ª One sample was confirmed positive by Western Blot
Ь One sample was confirmed positive by Comparative Assay