Comparative Evaluation of AmpliVue HSV 1+2 Assay with ELVIS Culture for Detecting Herpes Simplex Virus 1 (HSV-1) and HSV-2 in Clinical Specimens

Granato, Paul A.; Alkins, Brenda R.; Yen‐Lieberman, Belinda; Greene, Wallace; Connolly, Jessica; Buchan, Blake W.; Ledeboer, Nathan A.

doi:10.1128/jcm.01905-15

Cited by 18 publications

(13 citation statements)

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“…Other studies comparing HSV DNA-based NAATs to cell culture with molecular test discordant resolution have also reported greater sensitivity of those NAATs over culture [5][6][7][8][9][10][11][12], especially for detection of HSV-2 [9,10]. These studies used several different culture methods to evaluate the clinical performance of NAATs, including conventional culture [6,10], shell vial centrifugation culture [5,12], and ELVIS culture [7][8][9]11]. The shell vial centrifugation method used in the current study is faster than conventional culture and, unlike ELVIS, it can detect HSV-1 in HSV-2 positive specimens.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of a transcription mediated amplification assay for detection of herpes simplex virus types 1 and 2 mRNA in clinical specimens

Swenson

El-Sabaeny

Thomas-Moricz

et al. 2016

Journal of Clinical Virology

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Section: Discussionmentioning

confidence: 99%

“…However, the early DNA-based NAATs were laboratory-developed PCR assays that are not practical for many clinical laboratories. More recently, FDA-cleared NAATs for HSV DNA detection have become available which are more extensively validated and less labor intensive than laboratory-developed PCR assays [9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of a transcription mediated amplification assay for detection of herpes simplex virus types 1 and 2 mRNA in clinical specimens

Swenson

El-Sabaeny

Thomas-Moricz

et al. 2016

Journal of Clinical Virology

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“…For example, in an interesting twist, the AmpliVue platform uses a hybrid strategy composed of new molecular and classic LFIA approaches that avoids the need for an electronic reader. In this strategy, two tags (e.g., biotin and 6-carboxyfluorescein [FAM]) are incorporated into the DNA amplicon during the isothermal DNA amplification step, and then the presence of the amplified DNA is detected by LFIA (e.g., anti-FAM antibodies at the test line and streptavidin-conjugated colored particles as the detector) (33). Although they are not POC or CLIA waived, tests like these have made molecular test results available in Ͻ2 h, with a relatively large proportion of that time available as "walk away" time that frees the laboratory technologist for efforts elsewhere.…”

Section: Futurementioning

confidence: 99%

Point-of-Care Testing for Infectious Diseases: Past, Present, and Future

2017

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Point-of-care (POC) diagnostics provide rapid actionable information for patient care at the time and site of an encounter with the health care system. The usual platform has been the lateral flow immunoassay. Recently, emerging molecular diagnostics have met requirements for speed, low cost, and ease of use for POC applications. A major driver for POC development is the ability to diagnose infectious diseases at sites with a limited infrastructure. The potential use in both wealthy and resource-limited settings has fueled an intense effort to build on existing technologies and to generate new technologies for the diagnosis of a broad spectrum of infectious diseases.KEYWORDS infectious disease, lateral flow immunoassay, molecular diagnostic, point-of-care, rapid tests A point-of-care (POC) test is performed at or near the site where a patient initially encounters the health care system, has a rapid turnaround time (approximately 15 min), and provides actionable information that can lead to a change in patient management. Rapid results reduce the need for multiple patient visits, enable timely treatment, and facilitate the containment of infectious disease outbreaks. POC diagnostics also reduce the reliance on presumptive treatment and thereby facilitate antibiotic stewardship. Rapid diagnostic tests work by detecting analytes that are found in or extracted from clinical samples. There are two primary types of analytes: microbial antigens and patient antibodies that are specific for microbial antigens. However, there are emerging molecular technologies that enable nucleic acid-based approaches at the POC. In this minireview, we describe the origins and evolution of rapid POC tests, highlight several recent developments, and identify future directions that will move the field forward. PASTPerhaps the first large-scale use of the immunoassay for the diagnosis of infectious disease was in a report in 1917 by Dochez and Avery that pneumococcal polysaccharide can be detected by immunoassay of serum and urine from patients with lobar pneumonia (1). In a prescient comment, the authors suggested that antigen detection could enable a rapid diagnosis of infection. Interest in the immunoassay for an antigen or antibody for the diagnosis of disease was accelerated with the high sensitivity provided by the radioimmunoassay (RIA) in 1960 (2) and the enzyme-linked immunoassay (ELISA) in 1971 (3, 4). Indeed, the ELISA remains the dominant immunoassay platform technology in the non-POC central laboratory setting. Moreover, with automation, the ELISA technology also enables high-throughput sample processing. However, the ELISA and RIA platforms are also time consuming, have moderate or high complexity that requires trained laboratory personnel, and are typically equipment intensive. As a consequence, these technologies are not suited for POC use.The promise of immunoassays such as ELISA and RIA for the diagnosis of disease prompted numerous individuals and biotechnology companies to find the means to

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“…Various other presentations of HSV-1 and HSV-2 can occur, ranging from encephalitis to neonatal invasive infections. Although the clinical presentation of initial infection and reactivation of those viruses can be classic, atypical lesions occur and must be differ-entiated from other illnesses (5) and one virus from the others (6). Requirement for patient isolation and pharmacologic therapy depend on the specific viral etiology and the clinical presentation.…”

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confidence: 99%

Bayesian Evaluation of Solana HSV 1+2/VZV Assay Compared to Viral Culture and Commercial PCR Assay for Cutaneous or Mucocutaneous Specimens

et al. 2020

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Results from the Solana HSV 1+2/VZV assay for the detection of herpes simplex virus 1 (HSV-1), HSV-2, and varicella-zoster virus (VZV) in cutaneous or mucocutaneous specimens were compared with that of viral culture and a commercial PCR assay (RealStar alpha herpesvirus PCR kit). Three hundred two mucocutaneous specimens, for which HSV-1, HSV-2, or VZV viral culture or PCR detection have been requested, were randomly selected and prospectively processed on the Solana assay and viral culture or the RealStar assay. Discordant results between culture and the Solana assay were further analyzed using the RealStar assay. A Bayesian latent class model was developed to estimate the performance of each method. Viral culture detected 123 positive specimens (85 HSV-1, 36 HSV-2, and 2 VZV), while the Solana assay detected 27 additional positive specimens (4 HSV-1, 11 HSV-2, and 12 VZV), in agreement with the RealStar PCR assay. The estimated sensitivity of the Solana assay according to our model was 92.7% to 98.7%, 87.1% to 97.8%, and 94.9% to 98.8% (95% confidence interval [CI]) for HSV-1 HSV-2, and VZV, respectively, while the estimated sensitivity of viral culture was 85.2% to 95.0%, 73.6% to 89.6%, and 30.9% to 45.8% (95% CI), respectively. A nonsignificant tendency toward increased sensitivity was noted for the Solana assay compared with culture for HSV-1 and HSV-2, and the Solana assay was significantly more sensitive than culture for the detection of VZV. The Solana assay performed comparably to the RealStar assay. Processing time was reduced with the Solana assay compared with viral culture.

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Comparative Evaluation of AmpliVue HSV 1+2 Assay with ELVIS Culture for Detecting Herpes Simplex Virus 1 (HSV-1) and HSV-2 in Clinical Specimens

Cited by 18 publications

References 13 publications

Evaluation of a transcription mediated amplification assay for detection of herpes simplex virus types 1 and 2 mRNA in clinical specimens

Evaluation of a transcription mediated amplification assay for detection of herpes simplex virus types 1 and 2 mRNA in clinical specimens

Point-of-Care Testing for Infectious Diseases: Past, Present, and Future

Bayesian Evaluation of Solana HSV 1+2/VZV Assay Compared to Viral Culture and Commercial PCR Assay for Cutaneous or Mucocutaneous Specimens

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