herpeselect hsv-2 elisa (Focus Diagnostics Inc)
90
Structured Review
Focus Diagnostics Inc
herpeselect hsv-2 elisa
Herpeselect Hsv 2 Elisa, supplied by Focus Diagnostics Inc, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/herpeselect+hsv-2+elisa/herpeselect+2+elisa+igg/pm36626181-113-44-47
Average 90 stars, based on 1 article reviews
Herpeselect Hsv 2 Elisa, supplied by Focus Diagnostics Inc, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/herpeselect+hsv-2+elisa/herpeselect+2+elisa+igg/pm36626181-113-44-47
Average 90 stars, based on 1 article reviews
herpeselect hsv-2 elisa - by Bioz Stars,
2026-10
90/100 stars
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Enzyme-linked Immunosorbent Assay:Article Title: Effect of suppressive acyclovir administered to HSV-2 positive mothers from week 28 to 36 weeks of pregnancy on adverse obstetric outcomes: a double-blind randomised placebo-controlled trial Article Snippet: We screened consented women between 20 and 26 weeks of gestation for HSV-2 serostatus as determined by Article Title: Herpes simplex virus-2 infections in pregnant women from South Africa: Evaluation of the ImmunoFLOW rapid test Article Snippet: We used the Article Title: Incident HSV-2 Infections Are Common Among HIV-1-discordant Couples Article Snippet: HSV-2 Testing HSV-2 status was assessed by Article Title: Inflammatory cytokine biomarkers of asymptomatic sexually transmitted infections and vaginal dysbiosis: a multicentre validation study. Article Snippet: Inflammatory cytokine biomarkers of asymptomatic sexually transmitted infections and vaginal dysbiosis: a multicentre validation study lindi Masson, Shaun Barnabas, Jennifer Deese, Katie lennard, Smritee Dabee, Hoyam gamieldien, Shameem Z Jaumdally, anna-lise Williamson, Francesca little, lut Van Damme, Khatija ahmed, tania crucitti, Saïd abdellati, linda-gail Bekker, glenda gray, Janan Dietrich, Heather Jaspan, Jo-ann S Passmore Article Title: Quantitative Analyses of Regulatory Policies for Medical Devices: Matching the Methods to the Moment. Article Snippet: The US Food and Drug Administration (FDA) review of new medical devices attempts to balance access to new and useful technology alongside determinations of “reasonable assurance of safety and effectiveness.” Most reviewed devices receive clearance for marketing through the 510(k) pathway, the guiding principle of which is establishing substantial equivalence between a new device under consideration and a similar predicate device that has previously been authorized for market.1 This standard was developed both to eliminate undue burden for device manufacturers bringing medium-risk devices to market and to acknowledge practical resource limitations of the FDA, which evaluates approximately 30 devices a year in the more thorough premarket approval process but clears about 3000 devices annually via the 510(k) pathway.2 The 510(k) program and substantial equivalence as a regulatory benchmark have well-known shortcomings, comprehensively documented in a National Academy of Medicine (formerly the Institute of Medicine) report issued in 2011 that called for congressional action establishing a new pathway for medium-risk devices.1,3 In the ensuing decade, health law and policy scholars have repeated this message, citing problematic case studies, inadequate postmarket surveillance, and limited enforcement action all contributing to important patient safety concerns.4,5 The FDA has also acknowledged the need for modernization of 510(k), issuing updated guidance including incentivizing the use of more contemporary predicates or objective standards in a transition toward a safety and performance standard.6 Nevertheless, recent critiques call increasingly for complete replacement of 510(k), which would be achievable only through direct congressional action.7 Although powerful anecdotes and summary findings from public data sets tend to drive commentary around medical device regulation, few analyses have attempted to apply rigorous quantitative methods to draw causal inferences between policy features and regulatory outcomes.. This has largely been due to lack of structured data on device authorizations, supporting predicates, and downstream recalls.. Consequently, although calls to reform the 510(k) program have been numerous, few have been backed by rigorous scientific evidence, until now. Article Title: Herpes simplex virus-2 infections in pregnant women from South Africa: Evaluation of the ImmunoFLOW rapid test Article Snippet: This study compared the results of the ImmunoFLOW with the Article Title: School Support as Structural HIV Prevention for Adolescent Orphans in Western Kenya Article Snippet: DBS eluates were tested using the Article Title: Incident HSV-2 Infections Are Common Among HIV-1-discordant Couples Article Snippet: HSV-2 status was assessed by Clinical Proteomics:Article Title: Effect of suppressive acyclovir administered to HSV-2 positive mothers from week 28 to 36 weeks of pregnancy on adverse obstetric outcomes: a double-blind randomised placebo-controlled trial Article Snippet: We screened consented women between 20 and 26 weeks of gestation for HSV-2 serostatus as determined by Article Title: Herpes simplex virus-2 infections in pregnant women from South Africa: Evaluation of the ImmunoFLOW rapid test Article Snippet: We used the Article Title: Incident HSV-2 Infections Are Common Among HIV-1-discordant Couples Article Snippet: HSV-2 Testing HSV-2 status was assessed by Article Title: Inflammatory cytokine biomarkers of asymptomatic sexually transmitted infections and vaginal dysbiosis: a multicentre validation study. Article Snippet: Inflammatory cytokine biomarkers of asymptomatic sexually transmitted infections and vaginal dysbiosis: a multicentre validation study lindi Masson, Shaun Barnabas, Jennifer Deese, Katie lennard, Smritee Dabee, Hoyam gamieldien, Shameem Z Jaumdally, anna-lise Williamson, Francesca little, lut Van Damme, Khatija ahmed, tania crucitti, Saïd abdellati, linda-gail Bekker, glenda gray, Janan Dietrich, Heather Jaspan, Jo-ann S Passmore Article Title: Quantitative Analyses of Regulatory Policies for Medical Devices: Matching the Methods to the Moment. Article Snippet: The US Food and Drug Administration (FDA) review of new medical devices attempts to balance access to new and useful technology alongside determinations of “reasonable assurance of safety and effectiveness.” Most reviewed devices receive clearance for marketing through the 510(k) pathway, the guiding principle of which is establishing substantial equivalence between a new device under consideration and a similar predicate device that has previously been authorized for market.1 This standard was developed both to eliminate undue burden for device manufacturers bringing medium-risk devices to market and to acknowledge practical resource limitations of the FDA, which evaluates approximately 30 devices a year in the more thorough premarket approval process but clears about 3000 devices annually via the 510(k) pathway.2 The 510(k) program and substantial equivalence as a regulatory benchmark have well-known shortcomings, comprehensively documented in a National Academy of Medicine (formerly the Institute of Medicine) report issued in 2011 that called for congressional action establishing a new pathway for medium-risk devices.1,3 In the ensuing decade, health law and policy scholars have repeated this message, citing problematic case studies, inadequate postmarket surveillance, and limited enforcement action all contributing to important patient safety concerns.4,5 The FDA has also acknowledged the need for modernization of 510(k), issuing updated guidance including incentivizing the use of more contemporary predicates or objective standards in a transition toward a safety and performance standard.6 Nevertheless, recent critiques call increasingly for complete replacement of 510(k), which would be achievable only through direct congressional action.7 Although powerful anecdotes and summary findings from public data sets tend to drive commentary around medical device regulation, few analyses have attempted to apply rigorous quantitative methods to draw causal inferences between policy features and regulatory outcomes.. This has largely been due to lack of structured data on device authorizations, supporting predicates, and downstream recalls.. Consequently, although calls to reform the 510(k) program have been numerous, few have been backed by rigorous scientific evidence, until now. Article Title: Herpes simplex virus-2 infections in pregnant women from South Africa: Evaluation of the ImmunoFLOW rapid test Article Snippet: This study compared the results of the ImmunoFLOW with the Article Title: School Support as Structural HIV Prevention for Adolescent Orphans in Western Kenya Article Snippet: DBS eluates were tested using the Article Title: Incident HSV-2 Infections Are Common Among HIV-1-discordant Couples Article Snippet: HSV-2 status was assessed by |