Evaluation of three analyte-specific reagents for detection and typing of herpes simplex virus in cerebrospinal fluid

Selvaraju, Suresh B.; Wurst, Michelle N.; Horvat, Rebecca T.; Selvarangan, Rangaraj

doi:10.1016/j.diagmicrobio.2008.11.013

Cited by 27 publications

(11 citation statements)

References 18 publications

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“…The MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients. The assay provided similar sensitivity and specificity compare to two other commercial real-time PCR assays on CSF samples [46]. …”

Section: Introductionmentioning

confidence: 99%

Diagnosis of genital herpes simplex virus infection in the clinical laboratory

Goff

Péré

Bélec

2014

Virol J

153

106

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Since the type of herpes simplex virus (HSV) infection affects prognosis and subsequent counseling, type-specific testing to distinguish HSV-1 from HSV-2 is always recommended. Although PCR has been the diagnostic standard method for HSV infections of the central nervous system, until now viral culture has been the test of choice for HSV genital infection. However, HSV PCR, with its consistently and substantially higher rate of HSV detection, could replace viral culture as the gold standard for the diagnosis of genital herpes in people with active mucocutaneous lesions, regardless of anatomic location or viral type. Alternatively, antigen detection—an immunofluorescence test or enzyme immunoassay from samples from symptomatic patients--could be employed, but HSV type determination is of importance. Type-specific serology based on glycoprotein G should be used for detecting asymptomatic individuals but widespread screening for HSV antibodies is not recommended. In conclusion, rapid and accurate laboratory diagnosis of HSV is now become a necessity, given the difficulty in making the clinical diagnosis of HSV, the growing worldwide prevalence of genital herpes and the availability of effective antiviral therapy.

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Section: Introductionmentioning

confidence: 99%

Diagnosis of genital herpes simplex virus infection in the clinical laboratory

Goff

Péré

Bélec

2014

Virol J

153

106

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“…This group found the sensitivity and specifi city of the EraGen assay to be 100 % (25/25) and 100 % (43/43), respectively, using CSF samples that were known to be positive ( n = 25) or negative ( n = 43) for HSV type 1 or 2. In addition, they demonstrated that the analytical sensitivity of the assay was approximately 10 1 copies/reaction [ 44 ]. In March 2011, Becton Dickinson (BD; Franklin Lakes, NJ) was the second to receive FDA clearance for their BD ProbeTec™ HSV Q x assay, which uses strand displacement amplifi cation (SDA) technology.…”

Section: Regulatory Challengesmentioning

confidence: 99%

Detection of Herpes Simplex Virus in Cerebrospinal Fluid Using Real-Time PCR

Smith

Espy

Binnicker

2013

Molecular Diagnostics

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“…The Enzyme-Linked Virus Inducible System (ELVIS ® , Diagnostics Hybrids Inc., Athens, OH) has been widely used in clinical laboratories to detect the presence of HSV-1 or HSV-2 6–8. The transgenic shell vial cell culture-based test takes a minimum of 16 hours for results and it can only be performed in a laboratory setting with cell culture facility.…”

Section: Introductionmentioning

confidence: 99%

A rapid and simple isothermal nucleic acid amplification test for detection of herpes simplex virus types 1 and 2

Kim¹,

Tong²,

Tang³

et al. 2011

Journal of Clinical Virology

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Background A simple and rapid IsoAmp® HSV assay has been developed for qualitative detection of herpes simplex virus (HSV) types 1 and 2 from genital lesions. Sample preparation involved a simple dilution step and the diluted specimens were directly add to the device and amplified by isothermal helicase-dependent amplification (HDA). Amplification products were then detected by a DNA strip embedded in a disposable cassette without any instrument. The total test turn-around time is less than 1.5 hours from specimen processing to result reporting. Objectives To evaluate the analytical and clinical performance of the IsoAmp® HSV assay as well as the robustness and reproducibility of the assay. Study Design The analytical sensitivity of the IsoAmp® HSV assay were determined using both HSV-1 and HSV-2. Clinical performance was evaluated using 135 frozen specimens collected from patients with suspected HSV infection in genital area. Results The analytical sensitivity of the assays was 5.5 and 34.1 copies/reaction for HSV-1 and HSV-2 respectively with a 95% confidence interval. When the herpes viral culture was used as the reference standard, the clinical sensitivity and specificity of the IsoAmp® HSV assay were 100.0% and 96.3% respectively. The inter-laboratory reproducibility achieved an overall 97.5% agreement by testing a total of 80 blinded HSV-1 samples among five laboratories. Conclusion Adequate analytical and clinical performance of the IsoAmp® HSV assay was demonstrated. This assay is simple to perform and has acceptable inter-laboratory reproducibility.

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Evaluation of three analyte-specific reagents for detection and typing of herpes simplex virus in cerebrospinal fluid

Cited by 27 publications

References 18 publications

Diagnosis of genital herpes simplex virus infection in the clinical laboratory

Diagnosis of genital herpes simplex virus infection in the clinical laboratory

Detection of Herpes Simplex Virus in Cerebrospinal Fluid Using Real-Time PCR

A rapid and simple isothermal nucleic acid amplification test for detection of herpes simplex virus types 1 and 2

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