Rapid Diagnostic Tests For Diagnosis Research Articles

Evaluation of a haemozoin-based rapid diagnostic test for diagnosis of imported malaria during the phase of prevention of reestablishment in Sri Lanka

BackgroundSri Lanka, an island nation, has eliminated endemic malaria transmission. Maintaining elimination in the continued presence of vectors requires vigilance in screening people travelling from high malaria-risk areas and a rapid response with focal screening for infections identified in the community. Such screening requires accurate and very rapid assays that enable an immediate response. Both microscopy and rapid diagnostic tests (RDTs) have limitations including sensitivity and speed in screening large numbers, while polymerase chain reaction (PCR) is practical only as laboratory confirmation. This study assessed the utility of ‘Gazelle’, a novel rapid malaria assay based on magneto-optical detection of haemozoin, a by-product of malaria parasite metabolism.MethodsBetween October 2020 and March 2021, two groups of individuals were screened for malaria by four methods, namely, microscopy, Rapid Diagnostic Test (RDT), Gazelle and PCR. Passive case detection was carried out for confirmation of diagnosis amongst individuals suspected of having malaria. Individuals at high-risk of acquiring malaria, namely persons returning from malaria endemic countries, were screened by active case detection.ResultsOf the 440 individuals screened for malaria, nine malaria positives were diagnosed by PCR, microscopy and the HRP2 band of RDT, which included five Plasmodium falciparum infections, two Plasmodium ovale, and one each of Plasmodium vivax and Plasmodium malariae. Gazelle correctly detected the P. vivax, P. ovale and P. malariae infections within the 2 min test time, but did not detect two P. falciparum infections giving a sensitivity of 77.8%. Specificity was 100%.DiscussionThe Gazelle, a portable bench top device proved useful to screen a large number of blood samples for non-falciparum parasites within 5 minutes of sample input. Species differentiation, and improvement in P. falciparum detection, will be important to broaden utility.

Diagnostic accuracy of antigen-detection rapid diagnostic tests for diagnosis of COVID-19 in low-and middle-income countries: A systematic review and meta-analysis.

Antigen detection rapid diagnostic tests (Ag-RDTs) used for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein are inexpensive, faster and easy to use alternative of Nucleic Acid Amplification Test (NAAT) for diagnosis of Coronavirus disease 2019 (COVID-19). In this systematic review and meta-analysis, we assessed the diagnostic accuracy of Ag-RDTs in low and middle-income countries (LMICs). We included studies that evaluated the diagnostic accuracy of Ag-RDTs (sensitivity and specificity) against reverse transcription-polymerase chain reaction (RT-PCR) as a reference standard. The study population comprised of people living in LMICs irrespective of age and gender, who had undergone testing for COVID-19. We included peer reviewed prospective or retrospective cohort studies, cross-sectional studies, case control studies, randomized clinical trials (RCTs) as well as non-randomized experimental studies which addressed the review question. A systematic search was conducted in PubMed, CINAHL, Embase, Scopus, and Google Scholar to identify studies published between 1 January, 2020 and 15 August, 2021. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool was used to assess the methodological quality of studies. The analysis was done using Review Manager 5.4 and R software 4.0.2. From the total of 12 diagnostic accuracy studies with 4,817 study participants, pooled sensitivity and specificity were 78.2% and 99.5% respectively. Sensitivity was marginally higher in subgroup analysis based on studies with low risk of bias and applicability concerns (78.9%) and studies using SD Biosensor Ag-RDT (79.4%). However, an inverse relation between cycle threshold (Ct) and sensitivity of Ag-RDT was not seen. The review demonstrated pooled sensitivity value approaching the minimum performance requirement for diagnosis of COVID-19 by WHO with specificity value meeting the specified requirement. Ag-RDTs, therefore have the potential to be used as a screening tool for SARS-CoV-2 detection in low resource settings where RT-PCR might not be readily accessible. However, false negative results need to be interpreted with caution.

Performance of a Histidine Rich Protein-2 Based (First Response) and a p-Lactate Dehydrogenase-based (Optimal) Rapid Diagnostic Test for Diagnosis of Malaria in Patients With Pediatric Sickle Cell Disease.

Rapid diagnostic tests (RDTs) have been extensively evaluated and play an important role in malaria diagnosis. However, the accuracy of RDTs for malaria diagnosis in patients with sickle cell disease (SCD) is unknown. We compared the performance of a histidine rich protein 2 (HRP-2)-based RDT (First Response) and a lactate dehydrogenase (LDH)-based RDT (Optimal) with routine microscopy as reference standard in 445 children with SCD and an acute febrile illness in Accra, Ghana. The overall sensitivity, specificity, and positive and negative predictive values of the HRP-2-based RDTs were 100%, 95.7%, 73.8%, and 100%, respectively. Comparable values for the LDH-based RDTs were 91.7%, 99.5%, 95.7%, and 99.0%, respectively. A total of 423 results were true in both tests, 1 result was false in both tests, 16 results were false in the HRP-2 test only, and 5 were false in the LDH test only (McNemar test, P = .03). At follow-up, 73.7% (28/38), 52.6% (20/38), 48.6% (17/35), and 13.2% (5/38) of study participants were HRP-2 positive on days 14, 28, 35, and 42, respectively, compared with 0%, 2.6% (1/38), 2.9% (1/35), and 2.6% (1/38) for LDH. The HRP2-based RDT fulfilled World Health Organization criteria for malaria diagnosis in patients with SCD and may provide diagnostic evidence for treatment to begin in cases in which treatment would otherwise have begun presumptively based on symptoms, whereas LDH-based RDTs may be more suitable as a confirmatory test in low-parasitemic subgroups, such as patients with SCD.

COMPARISON OF FOURTH GENERATION ELISA AND RAPID DIAGNOSTIC TEST FOR DIAGNOSIS OF HEPATITIS C VIRUS(HCV) INFECTION IN A TERTIARY CARE HOSPITAL.

Introduction:Hepatitis C virus (HCV) infection has emerged as one of the major global health challenge affecting about 2 - 3% of the world population. Epidemiological studies have shown that HCV infection is a major risk factor for development of Acute hepatitis,chronic liver disease,cirrhosis and Hepatocellular carcinoma (HCC).Early diagnosis of HCV is important to link hepatitis testing to care and treatment initiation. Aim:To compare sensitivity and specificity of rapid diagnostic test (RDT) with fourth generation ELISA Material and Method: This study was conducted in the Department of Microbiology at Atal Bihari Vajpayee Institute of Medical Sciences (formerly Post Graduate Institute of Medical Education and Research) and Dr Ram Manohar Lohia Hospital from January 2018 to December 2018.Blood samples of patients suspected with hepatitis were tested using ELISA and rapid diagnostic test Results: In our study 26378 blood samples were tested for HCV,using fourth generation ELISA.Of these,581(2.20%) samples were found to be positive by ELISA.These HCV positive samples along with equal number of ELISA negative samples were tested by rapid diagnostic test. Sensitivity and specificity of the rapid diagnostic test was found to be 72.98 % and 100% respectively. Discussion:Rapid diagnostic test can be used during emergency hours but their results must be followed by ELISA test results in a tertiary care hospital.Reporting of false negative results should be minimized for rapid linkage to treatment initiation and to avoid silent transmission of infection.

A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study.

BackgroundRapid diagnostic tests (RDTs) have become widely used in low-resource settings for leptospirosis diagnostic. This study aims to evaluate the diagnostic performance of the five commercially available RDTs to detect human IgM against Leptospira spp. in Thai population.Methodology/Principal findingsNinety-nine serum samples from Leptospirosis suspicious patients were tested with five RDTs, including Medical Science Public Health, Leptocheck-WB, SD bioline, TRUSTline, and J.Mitra. The case definition was based on MAT, qPCR, and culture results. Diagnostic accuracy was determined based on the first day of enrollment in an overall analysis and stratified according to days post-onset of fever. The five RDTs had overall sensitivity ranging from 1.8% to 75% and specificity ranging from 52.3% to 97.7%. Leptocheck-WB had high sensitivity of 75.0%. The sensitivity of five RDTs increased on days 4–6 post-onset of fever, while the specificity of all tests remained relatively stable at different days post-onset of fever.Conclusions/SignificanceThe tested RDTs showed low sensitivity. Therefore, based on the present study, five commercially available RDTs might not be an appropriate test for acute leptospirosis screening in the Thai population.

Assessment of ASHA for knowledge, diagnosis and treatment on malaria in Mandla district of Madhya Pradesh as part of the malaria elimination demonstration project

Background The role of Accredited Social Health Activist (ASHA) in the health care delivery services at the periphery level is crucial for achieving disease prevention, control and elimination goals. The objective of the study was to assess the knowledge, attitude, practices, priorities and capability of ASHA related to malaria diagnosis and treatment as part of the Malaria Elimination Demonstration Project in 1233 villages of district Mandla, Madhya Pradesh.MethodsA cross sectional study was conducted using a fully structured, pre-tested interview schedule during June and July 2017 (before the field operations of MEDP were started). Two hundred twenty (17%) of the total ASHAs were selected for the interview from the 9 developmental blocks of Mandla district.ResultsKnowledge, Attitude and Practices (KAP) study revealed that most ASHAs knew that mosquitoes are the main agent for spread of malaria (97.7%). They mostly used Rapid Diagnostic Test (RDT) for diagnosis (91.8%). The majority (87.3%) correctly identified negative RDT result while only 15% and 10.5%, respectively, identified Plasmodium vivax and Plasmodium falciparum positive cases correctly. Further analysis showed that 85% ASHAs used chloroquine, 44.5% used artemisinin-based combination therapy (ACT), and 55.5% used primaquine for treatment of malaria. It was also found that only 38.2% ASHA gave PQ for 14 days in cases of P. vivax. At the time of the interview, 19.1% ASHAs did not have any RDTs for diagnosis and 47.7% reported not having ACT for treatment of P. falciparum malaria.ConclusionsThis study has revealed that ASHAs in the test district were not adequately trained or stocked for malaria parasite species identification and treatment, which are the major components of malaria elimination programme. This study has, therefore, revealed a need for training ASHAs on testing by RDT and proper treatment regimen for P. vivax and P. falciparum.

Comparative Study Of Blood Culture with Rapid Diagnostic Tests for Diagnosis Of Enteric Fever In A Tertiary Centre Of NE-India.

Introduction: Enteric fever is a global health problem and is also endemic in India. The laboratory diagnosis of enteric fever is very important mainly because in post-antibiotic era most cases are treated empirically and investigated for various causes of PUO including enteric fever. A fast, reliable, and easy to perform serodiagnostic test with a higher sensitivity and specificity is required for rapid diagnosis and management of typhoid cases, thereby enabling clinicians to initiate an early therapy, reducing morbidity and its complications.
 Aim : The study was performed to evaluate the performance of Widal test and Typhidot, a lateral flow immunoassay test.
 Materials and Methods: This study was carried out in the Department of Microbiology in a tertiary care center for 1 year (August 2016– July2017). A total of 110 blood samples were collected from patients (cases) clinically suspected of enteric fever. Culture and Serological tests were done in all the 110 cases. Salmonella isolation was done by conventional methods of culture. Demonstration of presence of anitibodies were done by Widal tests using commercially available kits. Typhidot, a lateral flow immunoassay, was used to test and detect IgM and IgG antibodies against the outer membrane protein (OMP) of the Salmonella Typhi. The performances of the tests were compared, and diagnostic accuracy determined.
 Results : Out of 110 cases, highest percentage of positive cases were found by Typhidot test (29.09%) followed by Widal test (23.63%) . 18.18% cases were confirmed by blood culture. Taking blood culture as gold standard , it was found that Widal test had a sensitivity of 30% and specificity of 78% and Typhidot had a sensitivity of 75% and specificity of 81%.
 Conclusion : Though definitive diagnosis of enteric fever is isolation of the causative organism from the patient, Widal test and Typhidot test are important diagnostic tools in the medical set up. Typhidot is fast becoming a practical alternative to Widal test. Typhidot test had a fairly good sensitivity and specificity, whereas Widal test had good specificity but a lower sensitivity.

Comparison of Malaria Rapid Diagnostic Test Kit and Microscopy

Malaria is the most common single diagnosis made in many countries in Africa. Microscopy is the gold standard for laboratory diagnosis of malaria parasite, but it requires adequate training and the time to get results is longer than that for Rapid Diagnostic Tests (RDTs). Use of RDTs is an alternative diagnostic method. This method is quick and easy to carry out. This study examined 412 blood samples of patients who met the study inclusion criteria from the health centres. All of the samples obtained were tested by SD Bioline malaria Ag P.f test commonly available in Nigeria and parasite count was done from thick film prepared. The results obtained were presented as a proportion positive in comparison to the total number of participants enrolled. Of the 412 enrollees, 284 were tested positive with malaria using the RDT, 400 were tested positive with microscopy and 12 were negative using microscopy and RDT. This study confirms the superior sensitivity of microscopy to RDTs in diagnosis of malaria. Although RDTs are very useful for quick diagnosis of malaria, particularly in areas where access to the use of microscopy is not available, the possibility of a low performance by RDTs in malaria diagnosis should be emphasized on health practitioners and microcopy should be encouraged as much as possible.

A Phase III Diagnostic Accuracy Study of a Rapid Diagnostic Test for Diagnosis of Second-Stage Human African Trypanosomiasis in the Democratic Republic of the Congo

ObjectivesTo estimate the diagnostic accuracy of HAT Sero K-SeT for the field diagnosis of second-stage human African trypanosomiasis (HAT). DesignA phase III diagnostic accuracy design. Consecutive patients with symptoms clinically suggestive of HAT were prospectively enrolled. We compared results of the index test HAT Sero K-SeT with those of a composite reference standard: demonstration of trypanosomes in cerebrospinal fluid (CSF), or trypanosomes detected in any other body fluid AND white blood cell count in CSF >5/μl. SettingRural hospital in the Democratic Republic of the Congo. ParticipantsAll patients above five years old presenting at Mosango hospital with a neurological problem of recent onset at the exclusion of trauma. Interventionsn.a. Main Outcome MeasuresSensitivity and specificity of HAT Sero K-SeT test. ResultsThe sensitivity of the HAT Sero K-SeT was 8/8 or 100.0% (95% confidence interval: 67.6 to 100.0%) and the specificity was 258/266 or 97.0% (94.2% to 98.5%). ConclusionThe high sensitivity of the HAT Sero K-SeT is in line with previously published estimates, though the sample of HAT cases in this study was small. The specificity estimate was very high and precise. This test, when negative, allows the clinician to rule out HAT in a clinical suspect in a hospital setting in this endemic region.

Comparative analysis of two rapid diagnostic tests for diagnosis of malaria in children, Gombe, north-east Nigeria

This study aims at comparing the diagnostic efficiencies of two commercially available kits for detecting Plasmodium falciparum infection in urine and blood of febrile patients for malaria diagnosis. This was an observational study in which matched blood and urine from symptomatic patients were tested for malaria using two rapid tests, with microscopy as gold standard. This was carried out in the pediatric clinic of Federal Teaching Hospital Gombe, North-east Nigeria were children enrolled who presented with fever (≥ 37.5oC). Thick films were prepared, stained and examined for malaria parasite under the microscope using the oil immersion objective while urine samples as well as blood were taken and immediately tested using Rapid Diagnostic Tests. With the blood smear microscopy as standard, the disease prevalence was 64% and sensitivity for both the UMT and SD Bio line (Blood RDT) was 85.7% respectively. However the diagnostic efficiency of this two test showed an 86.4% for UMT and 81.8% for SD-Bioline RDTs while the UMT had a specificity of 87.5% and 75% for SD Bio-line as well as the positive and negative predictive values were 92.3%, 85.7% and 77.8%, 75% respectively.These rapid diagnostic kits showed moderate level of sensitivity (85.7%) compared with blood smear microscopy (100%) as they show considerable acceptable levels above 80% in the effective diagnosis of malaria.Keywords: Diagnostic kits; Plasmodium falciparum; pediatric; prevalence; microscopy

Evaluation of the performances of twelve rapid diagnostic tests for diagnosis of HIV infection in Yaounde, Cameroon

According to the WHO/UNAIDS recommendations, an acceptable HIV rapid diagnostic tests (RDTs) has to perform a sensitivity≥99% and a specificity≥98%. Given the constant release of new RDTs for HIV testing in the market and the high HIV genetic diversity in Cameroon, it is interesting to monitor their performances in that setting.A total of 240 HIV positive (including 219 HIV-1 M, 15 HIV-1 O, 1 HIV-1 N, 1 HIV-1 M/O recombinant and 4 HIV-2) and 240 HIV negative plasma samples were used to evaluate twelve routinely used RDTs in Cameroon. A reference algorithm combining Enzyme Immunoassays and nucleic acid testing was used as gold standard.The sensitivity, specificity, positive predictive value, and negative predictive value of the twelve RDTs evaluated varied between 93.7 and 100%; 95.8 and 100%; 96.0 and 100%, and 94.1 and 100%, respectively. Five out of the twelve RDTs could not detect some HIV-1 O variants, one of them failed to detect an HIV-2 variant while all them efficiently detected HIV-1 N and HIV M/O recombinant.Our findings underscore the need to monitor the performances of RDTs to be used for HIV testing in Cameroon using locally obtained well-characterized samples panels.

The Validity of Rapid Malaria Test and Microscopy in Detecting Malaria in a Preelimination Region of Egypt.

Background. Malaria is a leading cause of morbidity and mortality worldwide. Rapid and accurate diagnosis of malaria would improve control measures and reduce morbidity and mortality. Objective. The aim of this study was to assess the prevalence of malaria in high risk foci in Egypt and the effectiveness of rapid diagnostic tests in diagnosis and subsequently control of malaria. Methodology. A total number of 600 cases of both sexes with different ages were included in the present study. Cases were included in 2 groups; first group (500 cases) were randomly selected from households in Fayoum Governorate and second group (100 cases) were admitted to Fayoum Fever Hospital with signs suggestive of malaria. Cases were subjected to detailed history taking, clinical examination, microscopic examination of thin and thick blood films, and immunological test to detect plasmodial antigens. Results. A total of 3 positive cases were detected by rapid diagnostic tests (RDTs). Out of these 3 cases, one case was positive for malaria parasite by microscopic examination of blood films. All positive cases in the study had history of travel to malaria endemic areas. Conclusion. RDTs are simple and effective for rapid diagnosis of malaria to help in implication of control measures in different localities.

Prospective Evaluation of Three Rapid Diagnostic Tests for Diagnosis of Human Leptospirosis

BackgroundDiagnosis of leptospirosis by the microscopic agglutination test (MAT) or by culture is confined to specialized laboratories. Although ELISA techniques are more common, they still require laboratory facilities. Rapid Diagnostic Tests (RDTs) can be used for easy point-of-care diagnosis. This study aims to evaluate the diagnostic performance of the RDTs LeptoTek Dri Dot, LeptoTek Lateral Flow, and Leptocheck-WB, prospectively.MethodologyDuring 2001 to 2012, one or two of the RDTs at the same time have been applied prior to routine diagnostics (MAT, ELISA and culture) on serum specimens from participants sent in for leptospirosis diagnosis. The case definition was based on MAT, ELISA and culture results. Participants not fulfilling the case definition were considered not to have leptospirosis. The diagnostic accuracy was determined based on the 1st submitted sample and paired samples, either in an overall analysis or stratified according to days post onset of illness.ResultsThe overall sensitivity and specificity for the LeptoTek Dri Dot was 75% respectively 96%, for the LeptoTek Lateral Flow 78% respectively 95%, and for the Leptocheck-WB 78% respectively 98%. Based on the 1st submitted sample the sensitivity was low (51% for LeptoTek Dri Dot, 69% for LeptoTek Lateral Flow, and 55% for Leptocheck-WB), but substantially increased when the results of paired samples were combined, although accompanied by a lower specificity (82% respectively 91% for LeptoTek Dri Dot, 86% respectively 84% for LeptoTek Lateral Flow, and 80% respectively 93% for Leptocheck-WB).ConclusionsAll three tests present antibody tests contributing to the diagnosis of leptospirosis, thus supporting clinical suspicion and contributing to awareness. Since the overall sensitivity of the tested RDTs did not exceed 80%, one should be cautious to rely only on an RDT result, and confirmation by reference tests is strongly recommended.

Evaluation of the Sensitivity of a pLDH-Based and an Aldolase-Based Rapid Diagnostic Test for Diagnosis of Uncomplicated and Severe Malaria Caused by PCR-Confirmed Plasmodium knowlesi, Plasmodium falciparum, and Plasmodium vivax

Plasmodium knowlesi can cause severe and fatal human malaria in Southeast Asia. Rapid diagnosis of all Plasmodium species is essential for initiation of effective treatment. Rapid diagnostic tests (RDTs) are sensitive for detection of uncomplicated and severe falciparum malaria but have not been systematically evaluated in knowlesi malaria. At a tertiary referral hospital in Sabah, Malaysia, we prospectively evaluated the sensitivity of two combination RDTs for the diagnosis of uncomplicated and severe malaria from all three potentially fatal Plasmodium species, using a pan-Plasmodium lactate dehydrogenase (pLDH)-P. falciparum histidine-rich protein 2 (PfHRP2) RDT (First Response) and a pan-Plasmodium aldolase-PfHRP2 RDT (ParaHIT). Among 293 hospitalized adults with PCR-confirmed Plasmodium monoinfection, the sensitivity of the pLDH component of the pLDH-PfHRP2 RDT was 74% (95/129; 95% confidence interval [CI], 65 to 80%), 91% (110/121; 95% CI, 84 to 95%), and 95% (41/43; 95% CI, 85 to 99%) for PCR-confirmed P. knowlesi, P. falciparum, and P. vivax infections, respectively, and 88% (30/34; 95% CI, 73 to 95%), 90% (38/42; 95% CI, 78 to 96%), and 100% (12/12; 95% CI, 76 to 100%) among patients tested before antimalarial treatment was begun. Sensitivity in severe malaria was 95% (36/38; 95% CI, 83 to 99), 100% (13/13; 95% CI, 77 to 100), and 100% (7/7; 95% CI, 65 to 100%), respectively. The aldolase component of the aldolase-PfHRP2 RDT performed poorly in all Plasmodium species. The pLDH-based RDT was highly sensitive for the diagnosis of severe malaria from all species; however, neither the pLDH- nor aldolase-based RDT demonstrated sufficiently high overall sensitivity for P. knowlesi. More sensitive RDTs are needed in regions of P. knowlesi endemicity.

Use of Rapid Diagnostic Tests for Diagnosis of Malaria in the United States

In the September issue of this journal, performance of BinaxNOW for the diagnosis of malaria in a major U.S. academic medical center was reported ([1][1]). Herein, we report performance of this test in a second large academic medical center in the United States. BinaxNOW was introduced at our

Specificity of malaria rapid diagnostic tests is affected by Trypanosoma brucei gambiense sleeping sickness

Background In endemic settings, diagnosis of malaria increasingly relies on the use of rapid diagnostic tests (RDTs) instead of microscopic examinations. False positivity of such RDTs is poorly documented, although it may be particularly relevant in infections for which the differential diagnosis includes malaria, such as sleeping sickness, a fatal but treatable disease caused by Trypanosoma brucei parasite subspecies. We therefore examined the effect of Trypanosoma brucei gambiense sleeping sickness on the specificity of malaria RDTs. Materials and methods Blood samples of 117 sleeping sickness patients and 117 matched non-sleeping sickness controls were prospectively collected in the Democratic Republic of the Congo. Reference malaria diagnosis was based on microscopy corrected by a four primer real-time PCR. Ten commonly used rapid diagnostic tests for malaria were evaluated including three two-band tests and seven three-band tests, based on the detection of Pf-HRP-2, Pf-pLDH and/or pan-pLDH antigens of Plasmodium. Results Specificity of RDTs for diagnosis of malaria in controls was between 97.5 and 100% and was between 11.3 and 98.8% in sleeping sickness patients. For seven out of 10 RDTs, specificity was significantly lower in sleeping sickness patients compared to controls. Decreased specificity of malaria RDTs in sleeping sickness was mainly caused by false positivity of the pan-pLDH test lines, but also occurred frequently for the HRP-2 test lines.The Pf-pLDH test lines were not affected. Conclusions

Performance of three multi-species rapid diagnostic tests for diagnosis of Plasmodium falciparum and Plasmodium vivax malaria in Oromia Regional State, Ethiopia

BackgroundMalaria transmission in Ethiopia is unstable and variable, caused by both Plasmodium falciparum and Plasmodium vivax. The Federal Ministry of Health (FMoH) is scaling up parasitological diagnosis of malaria at all levels of the health system; at peripheral health facilities this will be through use of rapid diagnostic tests (RDTs). The present study compared three RDT products to provide the FMoH with evidence to guide appropriate product selection.MethodsPerformance of three multi-species (pf-HRP2/pan-pLDH and pf-HRP2/aldolase) RDTs (CareStart®, ParaScreen® and ICT Combo®) was compared with 'gold standard' microscopy at three health centres in Jimma zone, Oromia Regional State. Ease of RDT use by health extension workers was assessed at community health posts. RDT heat stability was tested in a controlled laboratory setting according to WHO procedures.ResultsA total of 2,383 patients with suspected malaria were enrolled between May and July 2009, 23.2% of whom were found to be infected with Plasmodium parasites by microscopy. All three RDTs were equally sensitive in detecting P. falciparum or mixed infection: 85.6% (95% confidence interval 81.2-89.4). RDT specificity was similar for detection of P. falciparum or mixed infection at around 92%. For detecting P. vivax infection, all three RDTs had similar sensitivity in the range of 82.5 to 85.0%. CareStart had higher specificity in detecting P. vivax (97.2%) than both ParaScreen and ICT Combo (p < 0.001 and p = 0.05, respectively). Health extension workers preferred CareStart and ParaScreen to ICT Combo due to the clear labelling of bands on the cassette, while the 'lab in a pack' style of CareStart was the preferred design. ParaScreen and CareStart passed all heat stability testing, while ICT Combo did not perform as well.ConclusionsCareStart appeared to be the most appropriate option for use at health posts in Ethiopia, considering the combination of quantitative performance, ease of use and heat stability. When new products become available, the choice of multi-species RDT for Ethiopia should be regularly re-evaluated, as it would be desirable to identify a test with higher sensitivity than the ones evaluated here.

Performance of four rapid diagnostic tests for diagnosis of falciparum and non-falciparum malaria in endemic areas of Gondar region, Northern Ethiopia

Performance of four rapid diagnostic tests for diagnosis of falciparum and non-falciparum malaria in endemic areas of Gondar region, Northern Ethiopia

Evaluation of the performance of CareStart™ Malaria Pf/Pv Combo rapid diagnostic test for the diagnosis of malaria in Jimma, southwestern Ethiopia

Objective To evaluate the diagnostic performance of CareStart™ Malaria Pf/Pv Combo test relative to microscopy, for the diagnosis of falciparum and vivax malaria in Ethiopia. Methods Two hundred and forty febrile patients visiting the Serbo health center in Jimma zone, southwestern Ethiopia, were involved in this study in 2008. Giemsa-stained thin and thick blood smears were prepared and microscopically examined under a 100× oil immersion microscope objective for Plasmodium species identification and determination of parasitemia respectively. CareStart™ Malaria Pf/Pv Combo test was performed as per the manufacturers’ instruction. Findings The validity of CareStart™ Malaria Pf/Pv Combo test for the diagnosis of Plasmodium was very good with a sensitivity of 95.8%, specificity of 100%, positive predictive value of 100% and negative predictive value of 96%. The test performed equally well for the identification of Plasmodium falciparum and P. vivax. The diagnostic performance of this CareStart™ test is comparable to light microscopy of thin and thick blood smears. Conclusion Although CareStart™ Malaria Pf/Pv Combo test and blood microscopy have comparable diagnostic performance for Plasmodium detection, the CareStart™ test has the added advantage of being simple to interpret, cost-efficient, and hence it is preferable to use this rapid diagnostic test for malaria diagnosis in areas where microscopy is not accessible and during times of malaria epidemics that are observed approximately every 4–5 years in Ethiopia.

Feasibility and acceptability of home-based management of malaria strategy adapted to Sudan's conditions using artemisinin-based combination therapy and rapid diagnostic test

BackgroundMalaria remains a major public health problem especially in sub-Saharan Africa. Despite the efforts exerted to provide effective anti-malarial drugs, still some communities suffer from getting access to these services due to many barriers. This research aimed to assess the feasibility and acceptability of home-based management of malaria (HMM) strategy using artemisinin-based combination therapy (ACT) for treatment and rapid diagnostic test (RDT) for diagnosis.MethodsThis is a study conducted in 20 villages in Um Adara area, South Kordofan state, Sudan. Two-thirds (66%) of the study community were seeking treatment from heath facilities, which were more than 5 km far from their villages with marked inaccessibility during rainy season. Volunteers (one per village) were trained on using RDTs for diagnosis and artesunate plus sulphadoxine-pyrimethamine for treating malaria patients, as well as referral of severe and non-malaria cases. A system for supply and monitoring was established based on the rural health centre, which acted as a link between the volunteers and the health system. Advocacy for the policy was done through different tools. Volunteers worked on non-monetary incentives but only a consultation fee of One Sudanese Pound (equivalent to US$0.5).Pre- and post-intervention assessment was done using household survey, focus group discussion with the community leaders, structured interview with the volunteers, and records and reports analysis.Results and discussionThe overall adherence of volunteers to the project protocol in treating and referring cases was accepted that was only one of the 20 volunteers did not comply with the study guidelines. Although the use of RDTs seemed to have improved the level of accuracy and trust in the diagnosis, 30% of volunteers did not rely on the negative RDT results when treating fever cases. Almost all (94.7%) the volunteers felt that they were satisfied with the spiritual outcome of their new tasks. As well, volunteers have initiated advocacy campaigns supported by their village health committees which were found to have a positive role to play in the project that proved their acceptability of the HMM design. The planned system for supply was found to be effective. The project was found to improve the accessibility to ACTs from 25% to 64.7% and the treatment seeking behaviour from 83.3% to 100% before- and after the HMM implementation respectivly.ConclusionThe evaluation of the project identified the feasibility of the planned model in Sudan's condition. Moreover, the communities as well as the volunteers found to be satisfied with and supportive to the system and the outcome. The problem of treating other febrile cases when diagnosis is not malaria and other non-fever cases needs to be addressed as well.