scholarly journals Evaluation of the combination of Rapid Diagnostic Tests and microscopy for imported malaria surveillance in Anhui province, China

Author(s):  
Weidong Li ◽  
Xinzhou Zhang ◽  
Jun Feng ◽  
Tao Zhang ◽  
Xian Xu ◽  
...  

Abstract Background In the Anhui province, China, efforts to halt local malaria transmission were successful, with no endemic cases reported since 2014. Contrastingly, imported malaria cases are still being reported, indicating a disease reintroduction risk after years of eradication. To avoid this reintroduction, rapid diagnostic tests (RDTs) were combined with microscopy methods to strengthen malaria surveillance. Herein, we aimed to evaluate the efficacy of this surveillance strategy in a field setting. Methods We conducted a retrospective study using malaria surveillance data from January 2016 to June 2020. Epidemiological characteristics and diagnostic information were analysed using descriptive and comparative statistics. The diagnostic performance of the combined toolbox (RDTs plus microscopy) was evaluated based on its sensitivity, specificity, positive and negative predictive values, and Cohen’s kappa coefficient. Results The combined toolbox displayed a higher overall sensitivity for malaria cases than that of microscopy alone (93.74% vs 89.37%; χ2 = 6.09; p = 0.14). In contrast to its high sensitivity, the combined toolbox had a specificity of 69.66%. The species identification rates of the combined toolbox for P. falciparum, P. vivax, P. ovale, and P. malariae were 83.15%, 65.00%, 42.11%, and 40.00%, respectively. Conclusions The combination of microscopy and RDTs is an effective strategy for malaria surveillance, possibly detecting more P. falciparum infections than microscopy alone. However, the specificity and ability to identify species of the combined toolbox were not optimal. Thus, monitoring malaria cases in non-endemic areas may require employing more than one diagnostic tool in surveillance strategies. Moreover, further understanding of the advantages and disadvantages of different detection methods is necessary for applying optimum combinations in the field setting.

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Tao Zhang ◽  
Shuqi Wang ◽  
Duoquan Wang ◽  
Sarah Auburn ◽  
Shenning Lu ◽  
...  

Abstract Background Although autochthonous malaria cases are no longer reported in Anhui Province, China, imported malaria has become a major health concern. The proportion of reported malaria cases caused by Plasmodium ovale spp. increased to levels higher than expected during 2012 to 2019, and showed two peaks, 19.69% in 2015 and 19.35% in 2018. Methods A case-based retrospective study was performed using data collected from the China Information System for Disease Control and Prevention (CISDCP) and Information System for Parasitic Disease Control and Prevention (ISPDCP) from 2012 to 2019 to assess the trends and differences between Plasmodium ovale curtisi (P. o. curtisi) and Plasmodium ovale wallikeri (P. o. wallikeri). Epidemiological characteristics were analyzed using descriptive statistics. Results Plasmodium o. curtisi and P. o. wallikeri were found to simultaneously circulate in 14 African countries. Among 128 patients infected with P. ovale spp., the proportion of co-infection cases was 10.16%. Six cases of co-infection with P. ovale spp. and P. falciparum were noted, each presenting with two clinical attacks (the first attack was due to P. falciparum and the second was due to P. ovale spp.) at different intervals. Accurate identification of the infecting species was achieved among only 20.00% of cases of P. ovale spp. infection. At the reporting units, 32.17% and 6.96% of cases of P. ovale spp. infection were misdiagnosed as P. vivax and P. falciparum infections, respectively. Conclusion The present results indicate that the potential of P. ovale spp. to co-infect with other Plasmodium species has been previously underestimated, as is the incidence of P. ovale spp. in countries where malaria is endemic. P. o. curtisi may have a long latency period of > 3 years and potentially cause residual foci, thus posing challenges to the elimination of malaria in P. ovale spp.-endemic areas. Considering the low rate of species identification, more sensitive point-of-care detection methods need to be developed for P. ovale spp. and introduced in non-endemic areas.


2018 ◽  
Vol 69 (6) ◽  
pp. 1003-1010 ◽  
Author(s):  
Seble Girma ◽  
James Cheaveau ◽  
Abu Naser Mohon ◽  
Dewdunee Marasinghe ◽  
Ruth Legese ◽  
...  

Abstract Background As the global public-health objectives for malaria evolve from malaria control towards malaria elimination, there is increasing interest in the significance of asymptomatic infections and the optimal diagnostic test to identify them. Method We conducted a cross-sectional study of asymptomatic individuals (N = 562) to determine the epidemiological characteristics associated with asymptomatic malaria. Participants were tested by rapid diagnostic tests (CareStart, Standard Diagnostics [SD] Bioline, and Alere ultrasensitive RDT [uRDT]), loop-mediated isothermal amplification (LAMP), and quantitative reverse transcription polymerase chain reaction (qRT-PCR) to determine malaria positivity. Hemoglobin values were recorded, and anemia was defined as a binary variable, according to World Health Organization guidelines. Results Compared to reference qRT-PCR, LAMP had the highest sensitivity (92.6%, 95% confidence interval [CI] 86.4–96.5), followed by uRDT Alere Malaria (33.9%, 95% CI 25.5–43.1), CareStart Malaria (14.1%, 95% CI 8.4–21.5), microscopy (5.0%, 95% CI 1.8–10.5), and SD Bioline (5.0%, 95% CI 1.8–10.5). For Plasmodium falciparum specimens only, the sensitivity for uRDT Alere Malaria was 50.0% (95% CI 38.8–61.3) and SD Bioline was 7.3% (95% CI 2.7–15.3). Based on multivariate regression analysis with qRT-PCR as the gold standard, for every 3.2% increase in the prevalence of asymptomatic malaria, hemoglobin decreased by 1 gram per deciliter (prevalence ratio 0.968, 95% CI 0.940–0.997; P = .032). Deletions (4.8%) in hrp2 were noted. Conclusions While uRDT Alere Malaria has superior sensitivity to rapid diagnostic tests and microscopy in detecting asymptomatic malaria, LAMP is superior still. Ultrasensitive diagnostics provide the accurate prevalence estimates of asymptomatic malaria required for elimination.


2021 ◽  
Author(s):  
Loveness Mukuka ◽  
Andros Theo ◽  
Mowa Zambwe ◽  
Peter J Chipimo

Objective: To investigate the performance of the HIV RDTs used in Zambia. Method: 2,564 participants aged between 15 and 95 years from two sites in Lusaka province years were tested on OraQuick ADVANCE, Abbot Determine, and then confirmed on Uni-Gold Recombigen. The data from the participants were analyzed using SPSS version 25.0. Results: The 3 RDTs when compared to the 4th generation Abbot Architect results had the following results: OraQuick ADVANCE, Alere Determine and Uni-Gold Ultra, at 95% CI had Sensitivities of: 91.8%, 93.3% and 92.5% respectively. The specificities of OraQuick ADVANCE and Uni-Gold were the same (100.0%; 95% CI: 98.8 -100.0) but slightly different from Alere Determine (99.8%). Positive predictive values at 95% CI were 100% for OraQuick ADVANCE and Uni-Gold and 98.4% for Alere Determine. Negative predictive values (at 95% CIs) were 99.1, 99.2 and 99.1 for OraQuick ADVANCE, Alere Determine, and Uni-Gold Ultra respectively. The results showed that these RDTs could only detect 12 out of every 13 HIV positive results. Conclusion: Third generation RDTs are not effective in detecting acute positive cases. Fourth generation Rapid Tests are required to capture the positive cases being missed out.


2021 ◽  
Author(s):  
Helen R. Savage ◽  
Lorna Finch ◽  
Richard Body ◽  
Rachel L. Watkins ◽  
Gail Hayward ◽  
...  

AbstractObjectivesTo compare self-taken and healthcare worker (HCW)-taken throat/nasal swabs to perform rapid diagnostic tests (RDT) for SARS-CoV-2, and how these compare to RT-PCR. We hypothesised that self-taken samples are non-inferior for use with RDTs and in clinical and research settings could have substantial individual and public health benefit.DesignA prospective diagnostic accuracy evaluation as part of the ‘Facilitating Accelerated Clinical Evaluation of Novel Diagnostic Tests for COVID -19 (FALCON C-19), workstream C (undifferentiated community testing)’.SettingNHS Test and Trace drive-through community PCR testing site (Liverpool, UK). ParticipantsEligible participants 18 years or older with symptoms of COVID-19. 250 participants recruited; one withdrew before analysis.SamplingSelf-administered throat/nasal swab for the Covios® RDT, a trained HCW taken throat/nasal sample for PCR and HCW comparison throat/nasal swab for RDT.Main outcome measuresSensitivity, specificity, and positive and negative predictive values (PPV, NPV) were calculated; comparisons between self-taken and HCW-taken samples used McNemar’s test.ResultsSeventy-five participants (75/249, 30.1%) were positive by RT-PCR. RDTs with self-taken swabs had a sensitivity of 90.5% (67/74, 95% CI: 83.9-97.2), compared to 78.4% (58/74, 95% CI: 69.0-87.8) for HCW-taken swabs (absolute difference 12.2%, 95% CI: 4.7-19.6, p=0.003). Specificity for self-taken swabs was 99.4% (173/174, 95% CI: 98.3-100.0), versus 98.9% (172/174, 95% CI: 97.3-100.0) for HCW-taken swabs (absolute difference 0.6%, 95% CI: 0.5-1.7, p=0.317). The PPV of self-taken RDTs (98.5%, 67/68, 95% CI: 95.7-100.0) and HCW-taken RDTs (96.7%, 58/60, 95% CI 92.1-100.0) were not significantly different (p=0.262). However, the NPV of self-taken swab RDTs was significantly higher (96.1%, 173/180, 95% CI: 93.2-98.9) than HCW-taken RDTs (91.5%, 172/188, 95% CI 87.5-95.5, p=0.003).ConclusionSelf-taken swabs for COVID-19 testing offer substantial individual benefits in terms of convenience, accuracy, and reduced risk of transmitting infection. Our results demonstrate that self-taken throat/nasal samples can be used by lay individuals as part of rapid testing programmes for symptomatic adults.Trial RegistrationIRAS ID:28422, clinical trial ID: NCT04408170SummaryWhat is already known on this topic?Rapid diagnostic tests (RDTs)for SARS-CoV-2 Ag are a cheaper point-of-care alternative to RT-PCR for diagnosing COVID-19 disease.The accuracy of tests can vary dependent on sampling technique, test processing and reading of results.What this study adds?Self-taken throat-nasal swabs for RDTs can be used by symptomatic adults to give reliable results to diagnose SARS-CoV-2.Self-sampling can be implemented with little training and no assistance.


2020 ◽  
Author(s):  
Tao Zhang ◽  
Shuqi Wang ◽  
Duoquan Wang ◽  
Sarah Auburn ◽  
Shenning Lu ◽  
...  

Abstract BackgroundAlthough autochthonous malaria cases are no longer reported in Anhui Province, China, imported malaria has become a major health concern. The proportion of reported malaria cases caused by Plasmodium ovale spp. increased to levels higher than expected during 2012 to 2019, and showed two peaks, 19.69 % in 2015 and 19.35 % in 2018.MethodsA case-based retrospective study was performed using data collected from the China Information System for Disease Control and Prevention (CISDCP) and Information System for Parasitic Disease Control and Prevention (ISPDCP) from 2012 to 2019 to assess the trends and differences between Plasmodium ovale curtisi (P. o. curtisi) and Plasmodium ovale wallikeri (P. o. wallikeri). Epidemiological characteristics were analyzed using descriptive statistics.ResultsP. ovale curtisi and P. ovale wallikeri were found to simultaneously circulate in 14 African countries. Among 128 patients infected with P. ovale spp., the proportion of co-infection cases was 10.16%. Six cases of co-infection with P. ovale spp. and P. falciparum were noted, each presenting with two clinical attacks (the first attack was due to P. falciparum and the second was due to P. ovale spp.) at different intervals. Accurate identification of the infecting species was achieved among only 20.00% of cases of P. ovale spp. infection. At the reporting units, 32.17% and 6.96% of cases of P. ovale spp. infection were misdiagnosed as P. vivax and P. falciparum infections, respectively. ConclusionThe present results indicate that the potential of P. ovale spp. to co-infect with other Plasmodium species has been previously underestimated, as is the incidence of P. ovale spp. in countries where malaria is endemic. P. o. curtisi may have a long latency period of >3 years and potentially cause residual foci, thus posing challenges to the elimination of malaria in P. ovale spp.-endemic areas. Considering the low rate of species identification, more sensitive point-of-care detection methods need to be developed for P. ovale spp. and introduced in non-endemic areas.


2020 ◽  
Author(s):  
Tao Zhang ◽  
Shuqi Wang ◽  
Duoquan Wang ◽  
Sarah Auburn ◽  
Shenning Lu ◽  
...  

Abstract Background Although autochthonous malaria cases are no longer reported in Anhui Province, China, imported malaria has become a major health concern. The proportion of reported malaria cases caused by Plasmodium ovale spp. increased to levels higher than expected during 2012 to 2019, and showed two peaks, 19.69% in 2015 and 19.35% in 2018. Methods We conducted a case-based retrospective study, using data collected from the China Information System for Disease Control and Prevention and Information System for Parasitic Disease Control and Prevention from 2012–2019, to describe the trends and differences between P. o. curtisi and P. o. wallikeri. Epidemiological characteristics were analyzed using descriptive statistics. Results P. ovale curtisi and P. ovale wallikeri were found simultaneously circulating in 14 African countries. Among 128 patients infected with P. ovale spp., the proportion of mixed infection cases was 10.16%. Six cases of co-infection by P. ovale and P. falciparum were observed, each presenting with two clinical attacks (the first attack was due to P. falciparum and the second was due to P. ovale spp.) at different intervals. Accurate identification of the infecting species was achieved in only 20.00% of cases with P. ovale infection. At the reporting units, 32.17% and 6.96% of P. ovale spp. cases were misdiagnosed as P. vivax and P. falciparum, respectively. Conclusion Our finding indicates that the ability of P. ovale spp. to co-infect with other malarial species has been previously underestimated and providing rational evidence for the existence of hypnozoites in P. ovale spp. P. o. curtisi and P. o. wallikeri circulate simultaneously in Africa, and the incidence of P. ovale spp. is probably also underestimated in these source countries where the disease is endemic. Given the low rate of species identification, more sensitive point-of-care detection methods need to be developed for P. ovale spp., and introduced in non-endemic areas.


2018 ◽  
Vol 30 (4) ◽  
pp. 323-328 ◽  
Author(s):  
Margaret P Kasaro ◽  
Samuel Bosomprah ◽  
Melanie M Taylor ◽  
Ntazana Sindano ◽  
Caroline Phiri ◽  
...  

This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ≥1:4 were used to define active syphilis detection. Acceptability and feasibility were assessed using self-reported questionnaires. For Chembio, the HIV sensitivity was 90.6% (95%CI = 87.4, 93.0) and specificity was 97.2% (95%CI = 96.2, 97.8); syphilis sensitivity was 68.6% (95%CI = 61.9, 74.6) and specificity was 98.5% (95%CI = 97.8, 98.9). For SD Bioline, HIV sensitivity was 89.4% (95%CI = 86.1, 92.0) and specificity was 96.3% (95%CI = 95.3, 97.1); syphilis sensitivity was 66.2% (95%CI = 59.4, 72.4) and specificity was 97.2% (95%CI = 96.4, 97.9). Using the reference for active syphilis, syphilis sensitivity was 84.7% (95%CI = 76.1, 90.6) for Chembio and 81.6% (95%CI = 72.7, 88.1) for SD Bioline. Both rapid diagnostic tests were assessed as highly acceptable and feasible. In a field setting, the performance of both rapid diagnostic tests was comparable to other published field evaluations and each was rated highly acceptable and feasible. These findings can be used to guide further research and proposed scale up in antenatal clinic settings.


2014 ◽  
Vol 3 (1) ◽  
Author(s):  
Innocent C. Omalu ◽  
George Uzoaga ◽  
Israel Kayode Olayemi ◽  
Charles Mgbemena ◽  
Suleiman Hassan ◽  
...  

The global impact of malaria has spurred interest in developing prompt and accurate diagnostic strategies to provide an effective management of the disease. The aim of this study was to compare rapid diagnostic tests (RDTs) for malaria with routine microscopy. Samples were collected randomly from 364 febrile out-patients with clinical suspicion of malaria from four hospitals in North Central Nigeria. Results from the rapid diagnostic kits were analysed and compared to those obtained by general microscopy. Of the 364 out-patients involved in the study, 218 (59.89%) tested positive for <em>Plasmodium falciparum</em> by RDTs, whereas 263 (72.256%) tested positive by microscopy. There are significant differences (P&lt;0.05) in infection rates between RDT and microscopy. The sensitivity, specificity and negative predictive values of RDTs compared to microscopy are low, while the positive predictive value is high. Evaluation of RDTs against the parasite-positive panel with parasite densities of &lt;1000 parasites/μL, between 1000-5000 parasites/μL and above 5000 parasites/ μL was 11.73, 30.61, 57.65% for RDTs compared to 6.11, 27.95 and 65.94% for microscopy, respectively. Test line intensity increases with increase in parasite densities for both methods.


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