دورية أكاديمية
Performance and utility of more highly sensitive malaria rapid diagnostic tests.
| العنوان: | Performance and utility of more highly sensitive malaria rapid diagnostic tests. |
|---|---|
| المؤلفون: | Slater HC; Diagnostics Program, PATH, Seattle, WA, USA. hslater@path.org.; Malaria and Neglected Tropical Diseases, PATH, Seattle, WA, USA. hslater@path.org., Ding XC; Foundation for Innovative New Diagnostics, Geneva, Switzerland., Knudson S; Diagnostics Program, PATH, Seattle, WA, USA., Bridges DJ; PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia., Moonga H; National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia., Saad NJ; Médecins Sans Frontières, Phnom Penh, Preah Vihear, Cambodia., De Smet M; Médecins Sans Frontières, Brussels, Belgium., Bennett A; Malaria and Neglected Tropical Diseases, PATH, Seattle, WA, USA.; Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA., Dittrich S; Foundation for Innovative New Diagnostics, Geneva, Switzerland., Slutsker L; Malaria and Neglected Tropical Diseases, PATH, Seattle, WA, USA., Domingo GJ; Diagnostics Program, PATH, Seattle, WA, USA. |
| المصدر: | BMC infectious diseases [BMC Infect Dis] 2022 Feb 04; Vol. 22 (1), pp. 121. Date of Electronic Publication: 2022 Feb 04. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2334 (Electronic) Linking ISSN: 14712334 NLM ISO Abbreviation: BMC Infect Dis Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: London : BioMed Central, [2001- |
| مواضيع طبية MeSH: | Malaria*/diagnosis , Malaria*/epidemiology , Malaria, Falciparum*/diagnosis , Malaria, Falciparum*/epidemiology, Antigens, Protozoan ; Cross-Sectional Studies ; Diagnostic Tests, Routine ; Female ; Humans ; Plasmodium falciparum ; Pregnancy ; Protozoan Proteins ; Sensitivity and Specificity |
| مستخلص: | Background: A new more highly sensitive rapid diagnostic test (HS-RDT) for Plasmodium falciparum malaria (Alere™/Abbott Malaria Ag P.f RDT [05FK140], now called NxTek™ Eliminate Malaria Ag Pf) was launched in 2017. The test has already been used in many research studies in a wide range of geographies and use cases. Methods: In this study, we collate all published and available unpublished studies that use the HS-RDT and assess its performance in (i) prevalence surveys, (ii) clinical diagnosis, (iii) screening pregnant women, and (iv) active case detection. Two individual-level data sets from asymptomatic populations are used to fit logistic regression models to estimate the probability of HS-RDT positivity based on histidine-rich protein 2 (HRP2) concentration and parasite density. The performance of the HS-RDT in prevalence surveys is estimated by calculating the sensitivity and positive proportion in comparison to polymerase chain reaction (PCR) and conventional malaria RDTs. Results: We find that across 18 studies, in prevalence surveys, the mean sensitivity of the HS-RDT is estimated to be 56.1% (95% confidence interval [CI] 46.9-65.4%) compared to 44.3% (95% CI 32.6-56.0%) for a conventional RDT (co-RDT) when using nucleic acid amplification techniques as the reference standard. In studies where prevalence was estimated using both the HS-RDT and a co-RDT, we found that prevalence was on average 46% higher using a HS-RDT compared to a co-RDT. For use in clinical diagnosis and screening pregnant women, the HS-RDT was not significantly more sensitive than a co-RDT. Conclusions: Overall, the evidence presented here suggests that the HS-RDT is more sensitive in asymptomatic populations and could provide a marginal improvement in clinical diagnosis and screening pregnant women. Although the HS-RDT has limited temperature stability and shelf-life claims compared to co-RDTs, there is no evidence to suggest, given this test has the same cost as current RDTs, it would have any negative impacts in terms of malaria misdiagnosis if it were widely used in all four population groups explored here. (© 2022. The Author(s).) |
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| معلومات مُعتمدة: | OPP1135840 Bill and Melinda Gates Foundation |
| فهرسة مساهمة: | Keywords: Cross-sectional surveys; HS-RDT; Malaria diagnosis; Rapid diagnostic test |
| المشرفين على المادة: | 0 (Antigens, Protozoan) 0 (Protozoan Proteins) |
| تواريخ الأحداث: | Date Created: 20220205 Date Completed: 20220208 Latest Revision: 20220208 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC8815208 |
| DOI: | 10.1186/s12879-021-07023-5 |
| PMID: | 35120441 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1471-2334 |
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| DOI: | 10.1186/s12879-021-07023-5 |