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Article ; Online: Characterization of Serum Samples With Discordant Results in 2 Herpes Simplex Virus Type 2 IgG Assays.

Prince, Harry E / Batterman, Hollis J / Marlowe, Elizabeth M

2022 Volume 49, Issue 5, Page(s) 353–359

Abstract: Background: Our laboratory system tests sera for herpes simplex virus type 2 (HSV-2) IgG using the DiaSorin Liaison chemiluminescent immunoassay (CIA), with the option to confirm positive samples by a laboratory-developed HerpeSelect inhibition assay. ... ...

Abstract	Background: Our laboratory system tests sera for herpes simplex virus type 2 (HSV-2) IgG using the DiaSorin Liaison chemiluminescent immunoassay (CIA), with the option to confirm positive samples by a laboratory-developed HerpeSelect inhibition assay. As part of the confirmation process, the HerpeSelect HSV-2 IgG enzyme immunoassay (EIA) is performed. This study investigated the relationship between DiaSorin HSV-2 IgG CIA-positive indices and HerpeSelect HSV-2 IgG EIA results. Methods: HerpeSelect HSV-2 IgG EIA results were compiled for a cohort of consecutive DiaSorin HSV-2 IgG CIA-positive (index ≥1.10) samples. To further characterize DiaSorin CIA-positive samples that were positive (concordant) or negative (discordant) by the HerpeSelect EIA, a separate composite reference study panel was constructed and also tested using the Biokit HSV-2 IgG assay and an HSV-2 IgG inhibition assay developed for the DiaSorin instrument. Samples were classified as DiaSorin HSV-2 IgG true positive or false positive based on a composite reference using HerpeSelect EIA, Biokit, and DiaSorin inhibition results. Results: Of 2305 consecutive DiaSorin HSV-2 IgG CIA-positive samples, 411 (17.8%) were HerpeSelect HSV-2 IgG EIA negative; 343 of 411 (83%) had DiaSorin indices of 1.10 to 3.00. For the composite reference study panel (N = 120), 59 of 60 discordant samples were classified as DiaSorin HSV-2 IgG false positive based on the composite reference, whereas 58 of 60 concordant samples were classified as true positive. Conclusions: Nearly all DiaSorin HSV-2 IgG CIA-positive but HerpeSelect HSV-2 IgG EIA-negative sera are falsely positive in the DiaSorin CIA. Furthermore, most DiaSorin false-positive samples exhibit low-positive indices, suggesting that guidelines for confirmatory testing should include low-positive samples by CIA and EIA.
MeSH term(s)	Antibodies, Viral ; Enzyme-Linked Immunosorbent Assay/methods ; Female ; Herpes Genitalis/diagnosis ; Herpes Simplex/diagnosis ; Herpesvirus 2, Human ; Humans ; Immunoglobulin G ; Male ; Sensitivity and Specificity
Chemical Substances	Antibodies, Viral ; Immunoglobulin G
Language	English
Publishing date	2022-01-24
Publishing country	United States
Document type	Journal Article
ZDB-ID	435191-5
ISSN	1537-4521 ; 0148-5717
ISSN (online)	1537-4521
ISSN	0148-5717
DOI	10.1097/OLQ.0000000000001603
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Article ; Online: Transience of interference in an immunoassay measuring serum levels of beta-D-glucan.

Prince, Harry E / Batterman, Hollis J / Realegeno, Susan E / Marlowe, Elizabeth M

Diagnostic microbiology and infectious disease

2022 Volume 102, Issue 4, Page(s) 115630

Abstract: Some sera tested for 1-3-beta-D-glucan to identify invasive fungal infections exhibit interference. To assess interference transience, we evaluated results for 426 patients with an interference sample followed by a later sample. Interference was ... ...

Abstract	Some sera tested for 1-3-beta-D-glucan to identify invasive fungal infections exhibit interference. To assess interference transience, we evaluated results for 426 patients with an interference sample followed by a later sample. Interference was transient for 73% of patients (later sample negative or positive); median time between samples was 8 days.
MeSH term(s)	Glucans ; Humans ; Immunoassay ; Invasive Fungal Infections ; Proteoglycans ; beta-Glucans
Chemical Substances	Glucans ; Proteoglycans ; beta-Glucans
Language	English
Publishing date	2022-01-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	604920-5
ISSN	1879-0070 ; 0732-8893
ISSN (online)	1879-0070
ISSN	0732-8893
DOI	10.1016/j.diagmicrobio.2021.115630
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Article ; Online: Relationship between hepatitis C virus (HCV) IgG index values and quantitative HCV RNA results in HCV IgG-reactive serum samples.

Prince, Harry E / Marlowe, Elizabeth M / Schwab, Dale S

Diagnostic microbiology and infectious disease

2021 Volume 100, Issue 1, Page(s) 115311

Abstract: Centers for Disease Control guidelines recommend hepatitis C virus (HCV) RNA testing of all HCV IgG-reactive samples, although earlier studies found that IgG-reactive samples with low indices were negative in qualitative RNA assays. To determine if ... ...

Abstract	Centers for Disease Control guidelines recommend hepatitis C virus (HCV) RNA testing of all HCV IgG-reactive samples, although earlier studies found that IgG-reactive samples with low indices were negative in qualitative RNA assays. To determine if previous study results could be confirmed using current real-time RT-PCR technology, we investigated the relationship between HCV IgG index (Ortho VITROS) and quantitative HCV RNA results (cobas HCV) for 2368 consecutive IgG-reactive sera. Results were segregated into Low (1.00-16.0), Medium (16.1-30.0), and High (>30.0) IgG index groups. Although median viral load (VL) of RNA-positive samples was similar in all 3 groups, the percentage with low VL (1.18-4.16 log IU/mL) was increased for the Low group. Further analysis of the Low group revealed that 23 of 370 (6%) samples with IgG indices ≤8.00 were RNA-positive, and 13/23 (57%) had low VL. Our analysis supports the Centers for Disease Control recommendation to test all HCV IgG-reactive sera for HCV RNA.
MeSH term(s)	Female ; Hepacivirus/genetics ; Hepacivirus/immunology ; Hepatitis C/diagnosis ; Hepatitis C/immunology ; Hepatitis C/virology ; Hepatitis C Antibodies/blood ; Humans ; Immunoglobulin G/blood ; Male ; Middle Aged ; RNA, Viral/blood ; RNA, Viral/genetics ; Real-Time Polymerase Chain Reaction/methods ; Viral Load/methods
Chemical Substances	Hepatitis C Antibodies ; Immunoglobulin G ; RNA, Viral
Language	English
Publishing date	2021-01-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	604920-5
ISSN	1879-0070 ; 0732-8893
ISSN (online)	1879-0070
ISSN	0732-8893
DOI	10.1016/j.diagmicrobio.2021.115311
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Article ; Online: Relationship between DiaSorin Liaison Treponema pallidum antibody indices and confirmatory assay results in the reverse syphilis testing algorithm.

Prince, Harry E / Marlowe, Elizabeth M / Schwab, Dale A

Diagnostic microbiology and infectious disease

2020 Volume 100, Issue 1, Page(s) 115303

Abstract: Published studies show that >99% of sera reactive in the reverse syphilis testing algorithm (RSTA) screening assay with an index above an assay-specific threshold confirm as reactive, with either a rapid plasma reagin-reactive ( ... ...

Abstract	Published studies show that >99% of sera reactive in the reverse syphilis testing algorithm (RSTA) screening assay with an index above an assay-specific threshold confirm as reactive, with either a rapid plasma reagin-reactive (RPR
MeSH term(s)	Adult ; Algorithms ; Antibodies, Bacterial/blood ; Female ; Humans ; Immunoassay ; Linear Models ; Male ; Syphilis/diagnosis ; Syphilis/immunology ; Syphilis/microbiology ; Syphilis Serodiagnosis/methods ; Syphilis Serodiagnosis/standards ; Treponema pallidum/immunology
Chemical Substances	Antibodies, Bacterial
Language	English
Publishing date	2020-12-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	604920-5
ISSN	1879-0070 ; 0732-8893
ISSN (online)	1879-0070
ISSN	0732-8893
DOI	10.1016/j.diagmicrobio.2020.115303
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Article ; Online: Concordance of Results by Three Chagas Disease Antibody Assays in U.S. Clinical Specimens.

Moser, Matthew S / Fleischmann, Charles J / Kelly, Emily A / Prince, Harry E / Bern, Caryn / Whitman, Jeffrey D

Journal of clinical microbiology

2023 Volume 61, Issue 3, Page(s) e0181422

MeSH term(s)	Humans ; Chagas Disease/diagnosis ; Trypanosoma cruzi/genetics ; Antibodies, Protozoan ; Enzyme-Linked Immunosorbent Assay/methods
Chemical Substances	Antibodies, Protozoan
Language	English
Publishing date	2023-02-28
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/jcm.01814-22
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Zs.A 1188: Show issues

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Article ; Online: Herpes simplex virus type 2 (HSV-2) IgG index values in two immunoassays in relation to HSV-2 IgG inhibition assay results.

Prince, Harry E / Batterman, Hollis J / Schwab, Dale A

Diagnostic microbiology and infectious disease

2019 Volume 95, Issue 3, Page(s) 114864

Abstract: CDC guidelines recommend confirmatory testing of sera with low-positive indices (1.10-3.50) in the HerpeSelect® (HSLT) HSV-2 IgG screening assay. To determine if this recommendation is adequate for our patient population, we reviewed HSLT HSV-2 IgG ... ...

Abstract	CDC guidelines recommend confirmatory testing of sera with low-positive indices (1.10-3.50) in the HerpeSelect® (HSLT) HSV-2 IgG screening assay. To determine if this recommendation is adequate for our patient population, we reviewed HSLT HSV-2 IgG screening indices for 262 screen-positive sera (index >1.10) tested in our confirmatory assay, which assesses inhibition of binding to recombinant gG2 by HSV-1- and HSV-2-infected cell lysates. To determine how the recommendation affects other screening assays, we tested these samples in the Liaison® HSV-2 IgG assay. Of 124 false-positive sera, 20% and 39% had an index >3.50 in the HSLT and Liaison screening assays, respectively. In both assays, 51% of 63 indeterminate sera (inhibition by HSV-1 lysate) had indices >3.50. Similarly, ≥75% of 75 true-positive samples exhibited indices >3.50 in both assays. Thus, confirmatory testing only of sera with low-positive HSV-2 IgG indices misses some false-positive and indeterminate samples, leading to misdiagnosis of HSV-2 infection.
MeSH term(s)	Antibodies, Viral/blood ; False Positive Reactions ; Herpes Genitalis/diagnosis ; Herpesvirus 1, Human/immunology ; Herpesvirus 2, Human/immunology ; Herpesvirus 2, Human/isolation & purification ; Humans ; Immunoassay/standards ; Immunoglobulin G/blood ; Serologic Tests/standards ; Viral Envelope Proteins/immunology
Chemical Substances	Antibodies, Viral ; Immunoglobulin G ; Viral Envelope Proteins
Language	English
Publishing date	2019-07-13
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	604920-5
ISSN	1879-0070 ; 0732-8893
ISSN (online)	1879-0070
ISSN	0732-8893
DOI	10.1016/j.diagmicrobio.2019.07.002
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Article ; Online: Duration of West Nile Virus Immunoglobulin M Antibodies up to 81 Months Following West Nile Virus Disease Onset.

Staples, J Erin / Gibney, Katherine B / Panella, Amanda J / Prince, Harry E / Basile, Alison J / Laven, Janeen / Sejvar, James J / Fischer, Marc

The American journal of tropical medicine and hygiene

2022

Abstract: West Nile virus (WNV) IgM antibodies typically indicate a recent infection. However, WNV IgM antibodies can remain detectable for months to years following illness onset. We found that 23% (11/47) of samples tested with a WNV ELISA and 43% (20/47) of ... ...

Abstract	West Nile virus (WNV) IgM antibodies typically indicate a recent infection. However, WNV IgM antibodies can remain detectable for months to years following illness onset. We found that 23% (11/47) of samples tested with a WNV ELISA and 43% (20/47) of samples tested with WNV microsphere immunoassay (MIA) at 16-19 months following WNV illness onset were positive for IgM antibodies. The proportion of samples testing positive for WNV IgM by ELISA decreased over time, but 5% (2/44) of individuals remained positive at 60-63 months after their acute illness and 4% (2/50) were WNV IgM equivocal at 72-81 months. Testing by MIA showed the same general trend of decreased proportion positive over time though the rates of positivity were higher at most time points compared with the ELISA, including 6% (3/50) of participant's samples identified as IgM positive by MIA at 72-81 months post their acute illness. With the MIA, there also was a high proportion of samples with nonspecific results at each time point; average of 23% across all time points. Clinicians and public health officials should consider these findings along with clinical and epidemiologic data when interpreting WNV IgM antibody test results.
Language	English
Publishing date	2022-04-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	2942-7
ISSN	1476-1645 ; 0002-9637
ISSN (online)	1476-1645
ISSN	0002-9637
DOI	10.4269/ajtmh.21-1234
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Article ; Online: Evaluation of a multiplex bead immunoassay for determination of immune status to varicella-zoster virus in medical center students and employees.

Loeffelholz, Michael J / Prince, Harry E

Clinical and vaccine immunology : CVI

2015 Volume 22, Issue 3, Page(s) 351–353

Abstract: This study evaluated an enzyme immunoassay, a multiplex bead immunoassay (MBIA), and the anticomplement immunofluorescence (ACIF) test for detecting varicella-zoster virus IgG antibodies in sera from medical center students and employees. The agreement ... ...

Abstract	This study evaluated an enzyme immunoassay, a multiplex bead immunoassay (MBIA), and the anticomplement immunofluorescence (ACIF) test for detecting varicella-zoster virus IgG antibodies in sera from medical center students and employees. The agreement between methods was ≥95%. The MBIA was less sensitive than was the ACIF test, with a negative predictive value of 66.7%.
MeSH term(s)	Antibodies, Viral/blood ; Female ; Fluorescent Antibody Technique ; Health Personnel ; Herpesvirus 3, Human/immunology ; Humans ; Immunoassay/methods ; Immunoenzyme Techniques/methods ; Immunoglobulin G/blood ; Male ; Predictive Value of Tests ; Sensitivity and Specificity ; Students, Health Occupations ; Students, Medical
Chemical Substances	Antibodies, Viral ; Immunoglobulin G
Language	English
Publishing date	2015-03
Publishing country	United States
Document type	Evaluation Studies ; Journal Article
ZDB-ID	2221082-9
ISSN	1556-679X ; 1556-6811
ISSN (online)	1556-679X
ISSN	1556-6811
DOI	10.1128/CVI.00561-14
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Article ; Online: Reactivity of human IgM binding murine monoclonal 6B6C1 (IgG2a) with other murine monoclonal IgG antibodies.

Prince, Harry E / Yeh, Cindy

Journal of clinical laboratory analysis

2013 Volume 27, Issue 1, Page(s) 27–30

Abstract: Background: Approximately 6% of sera positive in a dengue virus IgM-capture enzyme immunoassay (EIA) represent false-positives due to interaction between IgM and horseradish peroxidase (HRP)-labeled monoclonal antibody (MAb) 6B6C1 (IgG2a). To better ... ...

Abstract	Background: Approximately 6% of sera positive in a dengue virus IgM-capture enzyme immunoassay (EIA) represent false-positives due to interaction between IgM and horseradish peroxidase (HRP)-labeled monoclonal antibody (MAb) 6B6C1 (IgG2a). To better understand this interaction, we assessed the reactivity of captured IgM from these sera with other HRP-labeled MAbs. Methods: Fifty dengue IgM false-positive sera (recognizing 6B6C1) were evaluated for IgM reactivity with the HRP-labeled MAbs H3A4 (IgG2a), 53.8 (IgG2b), and IL-A2 (IgG1). The sera were also tested in an EIA for human anti-mouse antibody (HAMA). Results: Forty-three sera (86%) reacted with IgG2a MAb (H3A4). Most (31/43 = 72%) of these sera recognizing 6B6C1 and H3A4 also recognized the IgG2 MAb and/or the IgG1 MAb. In contrast, HAMA was increased in only 9 of 50 (18%) sera reacting with 6B6C1. Conclusions: IgM from most sera-binding IgG2a MAb 6B6C1 also binds another IgG2a MAb, suggesting that IgM-6B6C1 reactivity is not idiotype specific. In many cases, IgM recognizing 6B6C1 also binds MAbs of other IgG subclasses, but is negative in a HAMA assay. These findings indicate that samples positive in IgM-capture EIAs utilizing conjugated MAbs should always be retested in the absence of antigen to identify false-positive reactivity caused by direct IgM-MAb interaction.
MeSH term(s)	Animals ; Antibodies, Monoclonal/chemistry ; Antibodies, Monoclonal/metabolism ; Antibody Specificity ; Dengue/blood ; Dengue/diagnosis ; Dengue/immunology ; False Positive Reactions ; Humans ; Immunoenzyme Techniques/methods ; Immunoenzyme Techniques/standards ; Immunoglobulin G/chemistry ; Immunoglobulin G/metabolism ; Immunoglobulin M/blood ; Immunoglobulin M/chemistry ; Immunoglobulin M/metabolism ; Mice ; Protein Binding
Chemical Substances	Antibodies, Monoclonal ; Immunoglobulin G ; Immunoglobulin M
Language	English
Publishing date	2013-01-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	645095-7
ISSN	1098-2825 ; 0887-8013
ISSN (online)	1098-2825
ISSN	0887-8013
DOI	10.1002/jcla.21557
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Article ; Online: Impact of the Yosemite hantavirus outbreak on hantavirus antibody testing at a national reference laboratory.

Prince, Harry E / Lieberman, Jay M

Clinical and vaccine immunology : CVI

2013 Volume 20, Issue 8, Page(s) 1213–1216

Abstract: In conjunction with the 2012 Yosemite hantavirus outbreak, the number of sera our facility tested for hantavirus antibodies increased. We tracked test results and used the data set to determine if a more efficient testing algorithm was possible. Sera ... ...

Abstract	In conjunction with the 2012 Yosemite hantavirus outbreak, the number of sera our facility tested for hantavirus antibodies increased. We tracked test results and used the data set to determine if a more efficient testing algorithm was possible. Sera were screened using laboratory-developed pan-hantavirus IgG and IgM enzyme immunoassays (EIAs), with an index of >1.10 defined as positive. Sera that were IgM positive by screening (screen IgM(+)) were tested for Sin Nombre virus (SNV)-specific IgM using a laboratory-developed EIA; screen IgM(+) IgG(+) sera were also tested for SNV IgG using a laboratory-developed immunoblot assay. SNV antibody-positive samples were sent to state public health laboratories (PHL) or the CDC for confirmation. Of 3,946 sera tested from July through December 2012, 205 were screen IgM(+) IgG negative (IgG(-)); 7/205 were SNV IgM(+), but only 1/5 sent to PHL/CDC was confirmed as SNV IgM(+). Of 61 screen IgM(+) IgG(+) sera, 16 were SNV antibody positive; 13/16 sera (from 11 patients) went to PHL/CDC, where SNV infection was confirmed for all patients. Of 12 confirmed patients, 7 had been exposed at Yosemite. A modified algorithm defining screen indices of ≥2.00 as positive identified 11/12 confirmed cases while reducing the number of sera requiring SNV-specific antibody testing by 65%; the patient missed was not tested until 3 months after the onset of symptoms. Hantavirus antibody testing at our facility identified 12 SNV-infected patients, including 7 exposed at Yosemite. Some screen IgM(+) IgG(-) SNV IgM(+) results were false positives, emphasizing the value of PHL/CDC confirmatory testing. We identified a modified algorithm requiring analysis of fewer specimens for SNV-specific antibodies without loss of sensitivity.
MeSH term(s)	Algorithms ; Antibodies, Viral/blood ; Clinical Laboratory Techniques/methods ; Disease Outbreaks ; Hantavirus Infections/diagnosis ; Humans ; Immunoassay/methods ; Immunoglobulin G/blood ; Immunoglobulin M/blood ; Sin Nombre virus/immunology ; United States/epidemiology ; Veterinary Medicine/methods
Chemical Substances	Antibodies, Viral ; Immunoglobulin G ; Immunoglobulin M
Language	English
Publishing date	2013-06-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	2221082-9
ISSN	1556-679X ; 1556-6811
ISSN (online)	1556-679X
ISSN	1556-6811
DOI	10.1128/CVI.00326-13
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