Poor specificity of this test in HIV-1 seropositive patients shows a need for additional commercially available for HSV-2 detection in these populations. These investigators found that the high false positivity rate of the HerpeSelect assay was a challenge in African sera. Performance of commercial Herpes Simplex Virus Type-2 antibody tests using serum samples from Sub-Sahara Africa: a systematic review and meta-analysis. Both of these assays have optimal accuracy in industrialized countries, while their performance on sera from developing countries has varied 6 Biraro, et al., 2011. While the University of Washington HSC Western blot (UW-WB) is expensive and technically difficult for screening and clinical trials, other commercial assays such as the Kalon (which is not yet FDA approved) and the FDA-cleared Focus HerpeSelct-2 IgG ELISA offer reliable assays for use in secondary research. found that the Kalon assay was reliable, stand-alone, on-site assay for detecting HSV-2 IgG antibodies. al., 5 Patel, et al., Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA: an international inter-laboratory assessment. The tests which performed the best were the Gull Premier EIA (sensitivity, 86.7% specificity 97.6%), and the Kalon Biological (sensitivity, 92.3% specificity, 97.7%) tests. Test sensitivities from 86% to 100%, while the specificity ranged from 47-99%. The discordant assays and the three best assays were compared to the Western blot assay from the University of Washington. Test samples were first compared to monoclonal antibody (MAb) enzyme immunoassays (EIA) from the Central Public Health Lab, London, UK. Performance of Commercially Available Enzyme Immunoassays for Detection of Antibodies against Herpes Simplex Virus Type 2 in African Populations. One review compared thirteen available commercial immunoassays for HSV-2 4 van Dyck, et al., 2004. DISCUSSION: Several reports have analyzed available commercial assays in the past. Sexually Transmitted Diseases Treatment Guidelines. False-positive results can bring emotional stress to the patient, and for this reason, a second test is often requested for a confirmatory result. The inaccuracy of Certain Commercial Enzyme Immunoassays in Diagnosing Genital Infections with Herpes Simplex Virus Types 1 and 2. While this FDA approved assay is considered to be very accurate, a second confirmatory assay is often preferred as most patients are unaware of their genital Herpes status 2 Ashley-Morrow, Rhoda, and David Friedrich, 2003. Of these, the University of Washington Western blot assay (UW-WB) is considered the “gold standard” for assays to detect Herpes virus antibodies in patient sera 1 University of Washington Western blot. INTRODUCTION: There are several commercial immunoassays for HSV on the market (Western blot, Dot blot or standard ELISA assays). Contact the University of Washington Clinical Virology Lab (206 685-8037) for ordering instructions.By David Kilpatrick, PhD and Abbas Vafai, PhD CSF antibody testing will be performed ONLY when paired with a serum sample. For accurate seroconversion determination, the acute and convalescent samples should be drawn at least 12 -16 weeks apart.įor CSF, see HSV SemiQnt Rapid PCR, Swab/CSF (Herpes Simplex Virus by PCR). It has not been cleared or approved by the US Food and Drug Administration.įor Paired samples, see Herpes Simplex Seroconversion Panel by Western Blot (Paired) for seroconversion on paired serum samples. This test was developed and its performance characteristics determined by the University of Washington Department of Laboratory Medicine and Pathology. HSV2 - Positive, Negative or Indeterminate.HSV1 - Positive, Negative or Indeterminate.The pattern of staining on the two blots (HSV-1 and HSV-2) is dictated by the number and identity of the HSV proteins to which the patient's immune system has antibody. Antibodies, which bind to the viral proteins, are detected by an enzyme-mediated color change. The strips of paper or "blots" containing separated fixed proteins from either HSV-1 or HSV-2 are incubated with the patient's serum. HSV1 and HSV2 proteins from detergent lysates ("Bernstein's lysate") of HSV infected cells are separated by electrophoresis and transferred to nitrocellulose paper. The detection of HSV1 and HSV2 IgG class antibodies by Western blot in serum or CSF.
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