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OBJECTIVE: To perform critical methodological assessments on designs, outcomes, quality and implementation limitations of studies evaluating the impact of malaria rapid diagnostic tests (mRDTs) on patient-important outcomes in sub-Saharan Africa. DESIGN: A systematic review of study methods. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, African Index Medicus and clinical trial registries were searched up to May 2022. ELIGIBILITY CRITERIA: Primary quantitative studies that compared mRDTs to alternative diagnostic tests for malaria on patient-important outcomes within sub-Sahara Africa. DATA EXTRACTION AND SYNTHESIS: Studies were sought by an information specialist and two independent reviewers screened for eligible records and extracted data using a predesigned form using Covidence. Methodological quality was assessed using the National Institutes of Health tools. Descriptive statistics and thematic analysis guided by the Supporting the Use of Research Evidence framework were used for analysis. Findings were presented narratively, graphically and by quality ratings. RESULTS: Our search yielded 4717 studies, of which we included 24 quantitative studies; (15, 62.5%) experimental, (5, 20.8%) quasi-experimental and (4, 16.7%) observational studies. Most studies (17, 70.8%) were conducted within government-owned facilities. Of the 24 included studies, (21, 87.5%) measured the therapeutic impact of mRDTs. Prescription patterns were the most reported outcome (20, 83.3%). Only (13, 54.2%) of all studies reported statistically significant findings, in which (11, 45.8%) demonstrated mRDTs' potential to reduce over-prescription of antimalarials. Most studies (17, 70.8%) were of good methodological quality; however, reporting sample size justification needs improvement. Implementation limitations reported were mostly about health system constraints, the unacceptability of the test by the patients and low trust among health providers. CONCLUSION: Impact evaluations of mRDTs in sub-Saharan Africa are mostly randomised trials measuring mRDTs' effect on therapeutic outcomes in real-life settings. Though their methodological quality remains good, process evaluations can be incorporated to assess how contextual concerns influence their interpretation and implementation. PROSPERO REGISTRATION NUMBER: CRD42018083816.
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Pruebas Diagnósticas de Rutina , Malaria , Humanos , África del Sur del Sahara , Malaria/diagnóstico , Malaria/tratamiento farmacológico , Prueba de Diagnóstico RápidoRESUMEN
BACKGROUND: Accurate diagnosis and timely treatment are crucial in combating malaria. METHODS: A total of 449 samples were screened for Plasmodium falciparum infection by expert microscopy, qPCR, and three RDTs, namely Rapigen Biocredit Malaria Ag Pf (detecting HRP2 and pLDH on separate bands), Abbott NxTek Eliminate Malaria Ag Pf (detecting HRP2), and SD Bioline Malaria Ag Pf (detecting HRP2). hrp2/3 deletion typing was done by digital PCR. RESULTS: 45.7% (205/449) individuals tested positive by qPCR for P. falciparum with a mean parasite density of 12.5 parasites/µL. Using qPCR as reference, the sensitivity of microscopy was 28.3% (58/205), the Biocredit RDT was 52.2% (107/205), the NxTek RDT was 49.3% (101/205), and the Bioline RDT was 39.5% (81/205). When only samples with densities > 20 parasites/µL were included (n = 89), sensitivity of 62.9% (56/89) by microscopy, 88.8% (79/89) by Biocredit, 88.8% (79/89) by NxTek, and 78.7% (70/89) by Bioline were obtained. All three RDTs demonstrated specificities > 95%. The limits of detection (95% probability that a sample tested positive) was 4393 parasites/µL (microscopy), 56 parasites/µL (Biocredit, considering either HRP2 or pLDH), 84 parasites/µL (NxTek), and 331 parasites/µL (Bioline). None of the three qPCR-confirmed P. falciparum positive samples, identified solely through the pLDH target, or eight samples negative for all RDTs but qPCR-positive at densities > 20 parasites/µL carried hrp2/3 deletions. CONCLUSION: The Biocredit and NxTek RDTs demonstrated comparable diagnostic efficacies. All three RDTs performed better than microscopy.
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Pruebas Diagnósticas de Rutina , Malaria Falciparum , Plasmodium falciparum , Sensibilidad y Especificidad , Malaria Falciparum/diagnóstico , Malaria Falciparum/parasitología , Humanos , Plasmodium falciparum/aislamiento & purificación , Plasmodium falciparum/genética , Ghana , Pruebas Diagnósticas de Rutina/métodos , Preescolar , Adolescente , Adulto , Niño , Adulto Joven , Femenino , Persona de Mediana Edad , Masculino , Microscopía/métodos , Lactante , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Anciano , Anciano de 80 o más Años , Prueba de Diagnóstico RápidoRESUMEN
Sickle cell diseases (SCD) are the most common genetic disorders with significant morbidity and mortality worldwide, including in India. The high prevalence of this disorder in many geographical regions calls for the use of a point-of-care rapid diagnostic test (RDT) for early screening and management of the diagnosed cases to reduce the allied clinical severity. In view of this, the present study was undertaken for the validation of a point-of-care RDT kit (SICKLECHECKTM) for the screening of SCD. This validation and diagnostic accuracy study was conducted among the cases advised for screening of SCD. For validation, all the recruited cases were investigated for both the SICKLECHECKTM RDT kit and HPLC (Variant-II) considering HPLC as a gold standard. A total of 400 cases were screened for both tests. For the presence and absence of sickle cell hemoglobin in the samples, SICKLECHECKTM RDT kit results showed a sensitivity and specificity of 99.39% and 98.73% respectively with references to HPLC findings. For the detection of the 'AS' pattern, the SICKLECHECKTM RDT kit has shown a sensitivity and specificity of 99.07% and 98.81% respectively. For the detection of the 'SS' pattern, the SICKLECHECKTM RDT kit has shown a sensitivity and specificity of 97.92% and 100.0% respectively. Cases with ß thalassemia trait, hemoglobin E trait, hemoglobin Lepore trait and trait for hereditary-persistence-of-fetal-hemoglobin (high HbF %) diagnosed in HPLC were resulted with 'AA' pattern in SICKLECHECKTM RDT kit. The high sensitivity and specificity of the SICKLECHECKTM RDT kit insist on its use as a point-of-care screening tool for SCD especially where there is a lack of laboratory facilities as well as in hospital-based set-up requiring immediate diagnosis and management of SCD. However, for further confirmation, the samples should be analyzed with other gold standard techniques like HPLC.
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Anemia de Células Falciformes , Prueba de Diagnóstico Rápido , Juego de Reactivos para Diagnóstico , Adolescente , Adulto , Niño , Femenino , Humanos , Masculino , Adulto Joven , Anemia de Células Falciformes/diagnóstico , Anemia de Células Falciformes/epidemiología , Anemia de Células Falciformes/sangre , Cromatografía Líquida de Alta Presión/métodos , Hemoglobina Falciforme/análisis , Hemoglobina Falciforme/genética , Tamizaje Masivo/métodos , Sensibilidad y EspecificidadRESUMEN
Chagas disease, caused by Trypanosoma cruzi, affects millions of people globally and is associated with significant underdiagnosis and undertreatment. Current diagnostic algorithms face challenges in remote regions. We aimed to review the potential of rapid diagnostic tests (RDTs) for screening or diagnosing chronic Chagas disease in endemic areas. An expert panel representing scientific and academic institutions from the Americas convened with the aim of discussing the use of RDTs. The study employed the nominal group technique, gathering insights from diverse experts during a 3-day meeting. Panel discussions covered RDT application, research protocols, and regulatory mechanisms. The results indicate that RDTs play a crucial role in surveillance and screening, although limitations in sensitivity and specificity exist. The expert group recommends standardized protocols, emphasizes the importance of cost-effectiveness assessments, and highlights the need to consider geographic validation. Despite these challenges, RDTs present a promising avenue for improving Chagas disease diagnosis in resource-limited settings. Future research and a collaborative approach are deemed essential for effective implementation.
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Enfermedad de Chagas , Pruebas Diagnósticas de Rutina , Trypanosoma cruzi , Enfermedad de Chagas/diagnóstico , Humanos , Pruebas Diagnósticas de Rutina/métodos , Trypanosoma cruzi/aislamiento & purificación , Enfermedad Crónica , Sensibilidad y Especificidad , Prueba de Diagnóstico RápidoRESUMEN
Regular monitoring of malaria rapid diagnostic tests (RDTs) for the management of uncomplicated malaria in healthcare facilities is a key factor in improving diagnostic quality and ensuring better case management. This study aimed to assess the performance of five RDTs (Standard Q Malaria P.f Ag and Standard Q Malaria P.f/Pan (SD Biosensor, Korea), One Step Malaria HRP2/pLDH (P.f/Pan) (Guangzhou Wondfo Biotech Co., Ltd., China), Malaria Pf/Pan (B&O Pharm, France), and Malaria test P.f/pan (Das Labor, Germany)) in two healthcare facilities in Abidjan. This cross-sectional study was conducted between September and October 2022. Overall, 250 patients suffering from uncomplicated malaria were included with a predominance of female patients (56.6%). The mean age was 22.3 years (SD = 20.6; range, 0.17-73). Of the patients tested, forty-six (46) tested positive for thick smears, reflecting a prevalence of 18.5%. Plasmodium falciparum was the most commonly detected species (93.5%). The geometric mean parasitemia was 6,111.80 parasites/µl (SD = 80,026.93) (range: 116-412461). The sensitivity ranged from 95.24% to 95.65%, whereas the specificity ranged from 93.07 to 94.09% for all five tests evaluated. The false positive rate of the tests was less than 10%. No invalid test results were reported. Two-thirds of P. malariae cases detected by microscopy showed also positive results with all the RDTs. All five RDTs showed 100% sensitivity at low parasitemia levels (< 1,000 parasites/µl blood) including three cases of parasites < 200 parasites/µl blood. This study demonstrated the importance of monitoring the performance of RDTs in clinical samples.
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Pruebas Diagnósticas de Rutina , Malaria , Humanos , Côte d'Ivoire/epidemiología , Femenino , Adulto , Persona de Mediana Edad , Adolescente , Adulto Joven , Masculino , Estudios Transversales , Preescolar , Niño , Malaria/diagnóstico , Lactante , Pruebas Diagnósticas de Rutina/métodos , Anciano , Sensibilidad y Especificidad , Instituciones de Salud , Prueba de Diagnóstico RápidoRESUMEN
Strongyloides stercoralis in humans often presents as a chronic asymptomatic infection. Diagnosis can be challenging due to the limited sensitivity of faecal-based parasitological techniques. A prototype lateral flow rapid diagnostic test (RDT) for the detection of specific antibodies against Strongyloides stercoralis (SsRapid) was evaluated using 143 samples from the serum bank of the Swiss Tropical and Public Health Institute. Group 1 (n = 30) comprised serum samples from larvae-positive individuals; the RDT's diagnostic sensitivity was 97 % (29/30). Group II comprised serum samples from patients with other parasitic infections (n = 86) and Swiss blood donors (n = 27); the RDT's diagnostic specificity for this group was 90 % (102/113). The RDT showed good diagnostic performance and is a promising point-of-care test for detecting human Strongyloides stercoralis infection.
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Anticuerpos Antihelmínticos , Sensibilidad y Especificidad , Strongyloides stercoralis , Estrongiloidiasis , Strongyloides stercoralis/inmunología , Strongyloides stercoralis/aislamiento & purificación , Estrongiloidiasis/diagnóstico , Animales , Humanos , Anticuerpos Antihelmínticos/sangre , Pruebas Diagnósticas de Rutina/métodos , Suiza , Prueba de Diagnóstico RápidoRESUMEN
BACKGROUND: Sporotrichosis is a chronic granulomatous infection of the skin and subcutaneous tissue that can affect any organ through lymphatic spread. The prevalence of sporotrichosis infections is increasing and its treatment is challenging as there are no unified and standard diagnostic techniques or antifungal medications. Controlling further spread requires a rapid diagnosis. Assessment of clinical symptoms, histological analysis, serological testing, and pathogen culture are all necessary for the diagnosis of sporotrichosis. However, these procedures are unable to identify the species. The development of safe, reliable, and species-specific diagnostic techniques is essential. OBJECTIVE: To establish and evaluate a new quantitative real-time PCR assay for the rapid diagnosis of sporotrichosis and to identify relevant species. METHODS: Polymorphisms in calmodulin (CAL) gene sequences and the internal transcribed spacer (ITS) were used in a quantitative real-time PCR assay to identify S. globosa, S. schenckii, and non-target species. RESULTS: The quantitative real-time PCR assay had 100% sensitivity and specificity. The limit of detection was 6 fg/µl. Thirty-four clinical specimens were verified to be infected with S. globosa with a 100% positive detection rate. CONCLUSIONS: The quantitative PCR technique developed in this study is a quick, accurate, and targeted method of identifying S. globosa based on polymorphisms in CAL sequences and ITS. It can be used for a prompt clinical diagnosis to identify S. globosa in clinical specimens from patients with sporotrichosis.
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Calmodulina , Reacción en Cadena en Tiempo Real de la Polimerasa , Sensibilidad y Especificidad , Sporothrix , Esporotricosis , Esporotricosis/diagnóstico , Esporotricosis/microbiología , Sporothrix/genética , Sporothrix/aislamiento & purificación , Humanos , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Calmodulina/genética , Asia , ADN de Hongos/genética , Técnicas de Diagnóstico Molecular/métodos , Prueba de Diagnóstico RápidoRESUMEN
BACKGROUND: This study aimed to demonstrate that the genomic material of SARS-CoV-2 can be isolated from strips of COVID-19 rapid diagnostic test cassettes. METHOD: It was a prospective cross-sectional study involving patients admitted to treatment centers and sampling sites in the city of Conakry, Guinea. A total of 121 patients were double sampled, and 9 more patients were tested only for RDT. PCR was conducted according to the protocol of the RunMei kit. Sequencing was performed by using the illumina COVIDSeq protocol. Nine COVID-19 RDTs without nasopharyngeal swabs were in addition tested. RESULT: Among the 130 COVID-19 RDTs, forty-seven were macroscopically positive, whereas seventy-two were positive according to PCR using RDT strip, while among the 121 VTM swabs, sixty-four were positive. Among eighty-three negative COVID-19 RDTs, twenty-seven were positive by PCR using RDT strip with a geometric mean Ct value of 32.49 cycles. Compared to those of PCR using VTM, the sensitivity and specificity of PCR using RDT strip were estimated to be 100% and 85.96%, respectively, with 93.39% test accuracy. Among the fifteen COVID-19 RDT extracts eligible for sequencing, eleven had sequences identical to those obtained via the standard method, with coverage between 75 and 99.6%. CONCLUSION: These results show that COVID-19 RDTs can be used as biological material for the genomic surveillance of SARS-CoV-2.
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Prueba de Ácido Nucleico para COVID-19 , COVID-19 , ARN Viral , SARS-CoV-2 , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , COVID-19/diagnóstico , COVID-19/virología , Prueba de Ácido Nucleico para COVID-19/métodos , Estudios Transversales , Pruebas Diagnósticas de Rutina/métodos , Genoma Viral/genética , Nasofaringe/virología , Estudios Prospectivos , Prueba de Diagnóstico Rápido/instrumentación , Tiras Reactivas , ARN Viral/genética , ARN Viral/aislamiento & purificación , SARS-CoV-2/genética , SARS-CoV-2/aislamiento & purificación , Sensibilidad y EspecificidadRESUMEN
Combination COVID-19/influenza rapid tests provide a way to quickly and accurately differentiate between the two infections. The goal of this economic evaluation was to assess the cost and health benefits of a combination COVID-19/influenza Rapid Diagnostic Test (RDT) vs. current standard-of-care in the Brazilian private healthcare setting. A dual decision tree model was developed to estimate the impact of rapid differentiation of COVID-19 and influenza in a hypothetical cohort of 1,000 adults with influenza-like illness in an ambulatory healthcare setting. The model compared the use of a combination COVID-19/influenza RDT to Brazil standard diagnostic practice of a COVID-19 RDT and presumptive influenza diagnosis. Different levels of influenza prevalence were modeled with co-infection estimated as a function of the COVID-19 prevalence. Outcomes included accuracy of diagnosis, antiviral prescriptions and healthcare resource use (hospital bed days and ICU occupancy). Depending on influenza prevalence, considering 1,000 patients with influenza-like illness, a combination RDT compared to standard practice was estimated to result in between 88 and 149 fewer missed diagnoses of influenza (including co-infection), 161 to 185 fewer cases of over-diagnosis of influenza; a 24 to 34% reduction in hospital bed days and a 16 to 26% reduction in ICU days. In the base case scenario (20% influenza, 5% COVID-19), the combination RDT was estimated to result in cohort cost savings of $99. Based upon a de novo economic model, this analysis indicates that use of a combination RDT could positively impact influenza antiviral prescriptions and lower healthcare resource use.
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COVID-19 , Gripe Humana , Humanos , COVID-19/diagnóstico , Brasil/epidemiología , Gripe Humana/diagnóstico , Gripe Humana/economía , Análisis Costo-Beneficio , Adulto , SARS-CoV-2 , Prueba de COVID-19/economía , Prueba de COVID-19/métodos , Coinfección , Prueba de Diagnóstico RápidoRESUMEN
It is difficult to differentiate between coronavirus disease 2019 (COVID-19) and influenza based on the symptoms. In the present study, a newly developed antigen rapid diagnostic test (Ag-RDT) called Panbio™ COVID-19/Flu A&B that can simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B virus was evaluated. Its accuracy was evaluated using 235 pairs of nasopharyngeal samples collected from patients with respiratory symptoms and fever (>37.5°C). Reverse transcription polymerase chain reaction was used as a reference method to evaluate the accuracy of the SARS-CoV-2 detection. We confirmed the accuracy of the developed Ag-RDT against the Omicron variant where the sensitivity and specificity were 94.8% and 100%, respectively. In addition, to identify the influenza A virus, a noninferiority test was conducted using a commercial Ag-RDT, which has a sensitivity and specificity in comparison with viral culture of 94.8% and 98.4%, respectively. The positive and negative predictive values for influenza A virus were 98.5% and 98.1%, respectively, for the Panbio COVID-19/Flu A&B test. The evaluation of this newly developed Ag-RDT using clinical samples suggests that it has a high efficacy in clinical settings.
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Antígenos Virales , COVID-19 , Virus de la Influenza A , Virus de la Influenza B , Gripe Humana , Prueba de Diagnóstico Rápido , SARS-CoV-2 , Adolescente , Adulto , Niño , Preescolar , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Antígenos Virales/inmunología , COVID-19/diagnóstico , COVID-19/inmunología , COVID-19/virología , Prueba Serológica para COVID-19/métodos , Virus de la Influenza A/inmunología , Virus de la Influenza A/aislamiento & purificación , Virus de la Influenza B/inmunología , Virus de la Influenza B/aislamiento & purificación , Gripe Humana/diagnóstico , Gripe Humana/virología , Gripe Humana/inmunología , Nasofaringe/virología , Prueba de Diagnóstico Rápido/instrumentación , SARS-CoV-2/inmunología , SARS-CoV-2/genética , Sensibilidad y Especificidad , Recién Nacido , LactanteRESUMEN
Paper-based rapid diagnostic tests (RDTs) are an essential component of modern healthcare, particularly for the management of infectious diseases. Despite their utility, these capillary-driven RDTs are compromised by high failure rates, primarily caused by user error. This limits their utility in complex assays that require multiple user operations. Here, we demonstrate how this issue can be directly addressed through continuous electrochemical monitoring of reagent flow inside an RDT using embedded graphenized electrodes. Our method relies on applying short voltage pulses and measuring variations in capacitive discharge currents to precisely determine the flow times of injected samples and reagents. This information is reported to the user, guiding them through the testing process, highlighting failure cases and ultimately decreasing errors. Significantly, the same electrodes can be used to quantify electrochemical signals from immunoassays, providing an integrated solution for both monitoring assays and reporting results. We demonstrate the applicability of this approach in a serology test for the detection of anti-SARS-CoV-2 IgG in clinical serum samples. This method paves the way towards "smart" RDTs able to continuously monitor the testing process and improve the robustness of point-of-care diagnostics.
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COVID-19 , Técnicas Electroquímicas , Papel , SARS-CoV-2 , Humanos , Técnicas Electroquímicas/instrumentación , Técnicas Electroquímicas/métodos , SARS-CoV-2/aislamiento & purificación , SARS-CoV-2/inmunología , COVID-19/diagnóstico , COVID-19/sangre , COVID-19/virología , Inmunoglobulina G/sangre , Inmunoglobulina G/análisis , Anticuerpos Antivirales/sangre , Anticuerpos Antivirales/inmunología , Electrodos , Inmunoensayo/instrumentación , Inmunoensayo/métodos , Prueba de Diagnóstico RápidoRESUMEN
All malaria-endemic countries in the Region of the Americas have taken on the challenge of eliminating the disease and have focused their health programs and strategies on that goal. This technical note provides guidance on actions to expand access to malaria diagnosis and treatment. Access to diagnosis is the foundation of the entire response to the disease. Despite repeated calls and efforts emphasizing the importance of early diagnosis and treatment for malaria elimination in the Americas, significant gaps remain. Lack of detection and/or late detection of cases undoubtedly continue to be factors that perpetuate malaria transmission in the Region. In areas with malaria transmission, diagnosis and treatment need to be available as close to people as possible: at the first point of contact with the health system, and in hard-to-reach areas, within the community itself. The Pan American Health Organization (PAHO) proposes a framework for action to improve access to malaria diagnosis and treatment based on expanded access to diagnosis, including expanded use of rapid diagnostic tests (RDTs) and immediate comprehensive treatment. This framework considers diagnostic methods and antimalarial drugs to be public goods. To achieve this change in malaria operations, it will be necessary to involve many more actors from the health system, affected communities, and society in general in malaria diagnosis and treatment. This strategy calls for an expansion of the diagnosis-treatment (DT) component of the Diagnosis, Treatment, Investigation, and Response (DT-IR) strategy that PAHO and partners in the Region have been promoting for malaria elimination in the Americas.
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Malaria , Prueba de Diagnóstico Rápido , Diagnóstico Precoz , Tiempo de Tratamiento , Enfermedades Transmitidas por VectoresRESUMEN
We aimed to assess the performance of Ag-RDT and RT-qPCR with regard to detecting infectious SARS-CoV-2 in cell cultures, as their diagnostic test accuracy (DTA) compared to virus isolation remains largely unknown. We searched three databases up to 15 December 2021 for DTA studies. The bivariate model was used to synthesise the estimates. Risk of bias was assessed using QUADAS-2/C. Twenty studies (2605 respiratory samples) using cell culture and at least one molecular test were identified. All studies were at high or unclear risk of bias in at least one domain. Three comparative DTA studies reported results on Ag-RDT and RT-qPCR against cell culture. Two studies evaluated RT-qPCR against cell culture only. Fifteen studies evaluated Ag-RDT against cell culture as reference standard in RT-qPCR-positive samples. For Ag-RDT, summary sensitivity was 93% (95% CI 78; 98%) and specificity 87% (95% CI 70; 95%). For RT-qPCR, summary sensitivity (continuity-corrected) was 98% (95% CI 95; 99%) and specificity 45% (95% CI 28; 63%). In studies relying on RT-qPCR-positive subsamples (n = 15), the summary sensitivity of Ag-RDT was 93% (95% CI 92; 93%) and specificity 63% (95% CI 63; 63%). Ag-RDT show moderately high sensitivity, detecting most but not all samples demonstrated to be infectious based on virus isolation. Although RT-qPCR exhibits high sensitivity across studies, its low specificity to indicate infectivity raises the question of its general superiority in all clinical settings. Study findings should be interpreted with caution due to the risk of bias, heterogeneity and the imperfect reference standard for infectivity.
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COVID-19 , SARS-CoV-2 , Sensibilidad y Especificidad , Humanos , SARS-CoV-2/aislamiento & purificación , SARS-CoV-2/genética , SARS-CoV-2/patogenicidad , COVID-19/diagnóstico , COVID-19/virología , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/métodos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/normas , Técnicas de Cultivo de Célula/métodos , Prueba de COVID-19/métodos , Prueba de Ácido Nucleico para COVID-19/métodos , Prueba de Diagnóstico RápidoRESUMEN
Private medicine retailers (PMRs) such as pharmacies and drug stores account for a substantial share of treatment-seeking for fever and malaria, but there are widespread concerns about quality of care, including inadequate access to malaria rapid diagnostic tests (RDTs) and artemisinin-based combination therapies (ACTs). This review synthesizes evidence on the effectiveness of interventions to improve malaria case management in PMRs in sub-Saharan Africa (PROSPERO #2021:CRD42021253564). We included quantitative studies evaluating interventions supporting RDT and/or ACT sales by PMR staff, with a historical or contemporaneous control group, and outcomes related to care received. We searched Medline Ovid, Embase Ovid, Global Health Ovid, Econlit Ovid and the Cochrane Library; unpublished studies were identified by contacting key informants. We conducted a narrative synthesis by intervention category. We included 41 papers, relating to 34 studies. There was strong evidence that small and large-scale ACT subsidy programmes (without RDTs) increased the market share of quality-assured ACT in PMRs, including among rural and poorer groups, with increases of over 30 percentage points in most settings. Interventions to introduce or enhance RDT use in PMRs led to RDT uptake among febrile clients of over two-thirds and dispensing according to RDT result of over three quarters, though some studies had much poorer results. Introducing Integrated Community Case Management (iCCM) was also effective in improving malaria case management. However, there were no eligible studies on RDT or iCCM implementation at large scale. There was limited evidence that PMR accreditation (without RDTs) increased ACT uptake. Key evidence gaps include evaluations of RDTs and iCCM at large scale, evaluations of interventions including use of digital technologies, and robust studies of accreditation and other broader PMR interventions.
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Antimaláricos , Artemisininas , Manejo de Caso , Malaria , Humanos , Malaria/tratamiento farmacológico , Malaria/diagnóstico , Artemisininas/uso terapéutico , África del Sur del Sahara/epidemiología , Antimaláricos/uso terapéutico , Pruebas Diagnósticas de Rutina/métodos , Farmacias , Quimioterapia Combinada , Prueba de Diagnóstico RápidoRESUMEN
BACKGROUND: Rapid diagnostic tests (RDTs) for coronavirus disease (COVID) are used in low- and middle-income countries (LMICs) to inform treatment decisions. However, to date, it is unclear when this use is cost-effective. Existing analyses are limited to a narrow set of countries and uses. The aim of this study is to assess the cost-effectiveness of COVID RDTs to inform the treatment of patients with severe illness in LMICs, considering real world practice. METHODS AND FINDINGS: We assessed the cost-effectiveness of COVID testing across LMICs using a decision tree model, differentiating results by country income level, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) prevalence, and testing scenario (none, RDTs, polymerase chain reaction tests-PCRs and combinations). LMIC experts defined realistic care pathways and treatment options. Using a healthcare provider perspective and net monetary benefit approach, we assessed both intended (COVID symptom alleviation) and unintended (treatment side effects) health and economic impacts for each testing scenario. We included the side effects of corticosteroids, which are often the only available treatment for COVID. Because side effects depend both on the treatment and the patient's underlying illness (COVID or COVID-like illnesses, such as influenza), we considered the prevalence of COVID-like illnesses in our analyses. We found that SARS-CoV-2 testing of patients with severe COVID-like illness can be cost-effective in all LMICs, though only in some circumstances. High influenza prevalence among suspected COVID cases improves cost-effectiveness, since incorrectly provided corticosteroids may worsen influenza outcomes. In low- and some lower-middle-income countries, only patients with a high index of suspicion for COVID should be tested with RDTs, while other patients should be presumed to not have COVID. In some lower-middle-income and upper-middle-income countries, suspected severe COVID cases should almost always be tested. Further, in these settings, negative test results in patients with a high initial index of suspicion should be confirmed through PCR and, during influenza outbreaks, positive results in patients with a low initial index of suspicion should also be confirmed with a PCR. The use of interleukin-6 receptor blockers, when supported by testing, may also be cost-effective in higher-income LMICs. The cost at which they would be cost-effective in low-income countries ($162 to $406 per treatment course) is below current prices. The primary limitation of our analysis is substantial uncertainty around some of the parameters in our model due to limited data, most notably on current COVID mortality with standard of care, and insufficient evidence on the impact of corticosteroids on patients with severe influenza. CONCLUSIONS: COVID testing can be cost-effective to inform treatment of LMIC patients with severe COVID-like disease. The optimal algorithm is driven by country income level and health budgets, the level of suspicion that the patient may have COVID, and influenza prevalence. Further research to better characterize the unintended effects of corticosteroids, particularly on influenza cases, could improve decision making around the treatment of those with COVID-like symptoms in LMICs.
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COVID-19 , Análisis Costo-Beneficio , Países en Desarrollo , SARS-CoV-2 , Humanos , COVID-19/diagnóstico , COVID-19/epidemiología , COVID-19/economía , Enfermedad Crítica/economía , Prueba de COVID-19/economía , Prueba de COVID-19/métodos , Árboles de Decisión , Prueba de Diagnóstico RápidoRESUMEN
The global malaria epidemic is still severe. Because of simple procedures, rapid detection and accuracy results, rapid diagnostic test (RDT) has become the most important and the most widely used diagnostic tool for malaria prevention and control. However, deletions in the RDT target Plasmodium falciparum histidine-rich protein 2/3 (Pfhrp2/3) genes may cause false-negative results of RDT, which has been included as one of the four biological threats to global malaria elimination. This article reviews the applications of RDT in the global malaria diagnosis, analyzes the threats and challenges caused by Pfhrp2/3 gene deletion, proposes methods for monitoring Pfhrp2/3 gene deletion, and summarizes the causes and countermeasures of negative RDT detections, so as to provide insights into consolidation of malaria elimination achievements in China and contributions to global malaria elimination.
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Antígenos de Protozoos , Eliminación de Gen , Malaria Falciparum , Plasmodium falciparum , Proteínas Protozoarias , Proteínas Protozoarias/genética , Humanos , Antígenos de Protozoos/genética , Plasmodium falciparum/genética , Malaria Falciparum/diagnóstico , Malaria Falciparum/prevención & control , Malaria Falciparum/parasitología , Pruebas Diagnósticas de Rutina/métodos , China/epidemiología , Prueba de Diagnóstico RápidoRESUMEN
BACKGROUND: Southern African countries have the largest global burden of HIV and syphilis, with a high prevalence among women of reproductive age. Although antenatal screening is standard of care, syphilis screening has generally lagged behind HIV screening. We aimed to evaluate the performance and operational characteristics of two commercial dual HIV/syphilis point-of-care tests (POCTs) for simultaneous maternal HIV/syphilis screening. METHODS: A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and Zambia. POCT results using capillary fingerprick blood were compared to reference laboratory syphilis and HIV serological assays. RESULTS: Three thousand four hundred twelve consenting pregnant women aged ≥ 18 years were enrolled. The prevalence of treponemal antibody seropositivity and HIV infection ranged from 3.7 to 9.9% (n = 253) and 17.8 to 21.3% (n = 643), respectively. Pooled sensitivity for syphilis compared to the reference assay was 66.0% (95%CI 57.7-73.4) with SD Bioline and 67.9% (95%CI 58.2-76.3) with Chembio. Pooled specificity for syphilis was above 98% with both POCTs. The sensitivities of SD Bioline and Chembio assays were 78.0% (95%CI 68.6-85.7) and 81.0% (95%CI 71.9-88.2), respectively compared to an active syphilis case definition of treponemal test positive with a rapid plasma reagin titre of ≥ 8. The negative predictive values (NPVs) based on various prevalence estimates for syphilis with both assays ranged from 97 to 99%. The pooled sensitivity for HIV was 92.1% (95%CI 89.4-94.2) with SD Bioline; and 91.5% (95%CI 88.2-93.9) with Chembio. The pooled specificities for HIV were 97.2% (95%CI 94.8-98.5) with SD Bioline and 96.7% (95%CI 95.1-97.8) with Chembio. The NPV based on various prevalence estimates for HIV with both assays was approximately 98%. Most participating women (91%) preferred dual POCTs over two single POCTs for HIV and syphilis, and healthcare providers gave favourable feedback on the utility of both assays at PHC level. CONCLUSIONS: Based on the need to improve antenatal screening coverage for syphilis, dual HIV/syphilis POCTs could be effectively incorporated into antenatal testing algorithms to enhance efforts towards elimination of mother-to-child transmission of these infections.
Asunto(s)
Infecciones por VIH , Complicaciones Infecciosas del Embarazo , Sensibilidad y Especificidad , Sífilis , Humanos , Zambia/epidemiología , Femenino , Sífilis/diagnóstico , Sífilis/epidemiología , Infecciones por VIH/diagnóstico , Infecciones por VIH/epidemiología , Embarazo , Sudáfrica/epidemiología , Adulto , Adulto Joven , Complicaciones Infecciosas del Embarazo/diagnóstico , Complicaciones Infecciosas del Embarazo/epidemiología , Adolescente , Sistemas de Atención de Punto , Atención Primaria de Salud , Pruebas en el Punto de Atención , Prevalencia , Tamizaje Masivo/métodos , Atención Prenatal , Pruebas Diagnósticas de Rutina/métodos , Prueba de Diagnóstico RápidoRESUMEN
BACKGROUND: The recommendation of universal diagnostic testing before malaria treatment aimed to address the problem of over-treatment with artemisinin-based combination therapy and the heightened risk of selection pressure and drug resistance and the use of malaria rapid diagnostic test (MRDT) was a key strategy, particularly among primary healthcare (PHC) workers whose access to and use of other forms of diagnostic testing were virtually absent. However, the use of MRDT can only remedy over-treatment when health workers respond appropriately to negative MRDT results by not prescribing anti-malarial drugs. This study assessed the use of MRDT and anti-malarial drug prescription practices, and the predictors, among PHC workers in Ebonyi state, Nigeria. METHODS: We conducted an analytical cross-sectional questionnaire survey, among consenting PHC workers involved in the diagnosis and treatment of malaria, from January 15, 2020 to February 5, 2020. Data was collected via structured self-administered questionnaire and analysed using descriptive statistics and bivariate and multivariate generalized estimating equations. RESULTS: Of the 490 participants surveyed: 81.4% usually/routinely used MRDT for malaria diagnosis and 18.6% usually used only clinical symptoms; 78.0% used MRDT for malaria diagnosis for all/most of their patients suspected of having malaria in the preceding month while 22.0% used MRDT for none/few/some; 74.9% had good anti-malarial drug prescription practice; and 68.0% reported appropriate response to negative MRDT results (never/rarely prescribed anti-malarial drugs for the patients) while 32.0% reported inappropriate response (sometimes/often/always prescribed anti-malarial drugs). The identified predictor(s): of the use of MRDT was working in health facilities supported by the United States' President's Malaria Initiative (PMI-supported health facilities); of good anti-malarial drug prescription practice were having good opinion about MRDT, having good knowledge about malaria diagnosis and MRDT, being a health attendant, working in PMI-supported health facilities, and increase in age; and of appropriate response to negative MRDT results was having good opinion about MRDT. CONCLUSIONS: The evidence indicate the need for, and highlight factors to be considered by, further policy actions and interventions for optimal use of MRDT and anti-malarial drug prescription practices among the PHC workers in Ebonyi state, Nigeria, and similar settings.
Asunto(s)
Antimaláricos , Pruebas Diagnósticas de Rutina , Personal de Salud , Malaria , Atención Primaria de Salud , Humanos , Nigeria , Antimaláricos/uso terapéutico , Estudios Transversales , Malaria/tratamiento farmacológico , Malaria/diagnóstico , Femenino , Adulto , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Prescripciones de Medicamentos/estadística & datos numéricos , Prueba de Diagnóstico RápidoRESUMEN
Koi(Cyprinus carpio) is an ornamental variety of common carp frequently kept as pets. Given their long lifespan, neoplasia, albeit uncommon, may occur in these animals, and only a few studies have faced their cytological diagnosis. In the present case, a koi carp was referred to the clinicians due to coelomic swelling. The carp underwent surgery, which revealed an enlargement of both testes. Testicular samples were cytologically and histologically examined. The lesion was diagnosed as a seminoma since it was composed of round, large, atypical, and often multinucleated cells with round central nuclei and moderate cytoplasm. These tumors had the same appearance as seminomas in mammals and should be considered among differential diagnoses when coelomic swelling occurs in koi carp. Seminomas in koi carp are diagnosed histologically, but cytology, a rapid and cheap exam executable in all veterinary clinical facilities, could be a relevant preliminary diagnostic tool that may influence the entire diagnostic process.