scholarly journals Quality Assurance (QA) Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A cross-sectional prospective study.

Author(s):  
Metuschelah Habimana

Abstract Background Currently, malaria rapid diagnostic tests (mRDTs) are increasingly used for the diagnosis of malaria, particularly in communities where microscopy-based diagnosis is not practical. However, the diagnostic accuracy of mRDTs performed by community health workers (CHWs) remains unknown. This study was conducted to determine the accuracy of mRDT results performed by CHWs in Ngoma district, eastern province of Rwanda. Method This was a cross sectional prospective study. A total of 420 blood samples of patients self-reported to CHWs for malaria diagnosis were collected and analyzed by CHWs using mRDT, and quality control tests were performed by using microscopy as a reference test. The study was conducted from 22 April to 08 July 2021. Results Among the 420 patients, 234 (55.71%) were females, and 186 (44.29%) were males. Malaria test positivity was 2.62% by using mRDT and 1.67% by using microscopic tests. The sensitivity and specificity of mRDT were 85.71% and 98.78%, respectively. The negative predictive value, positive predictive value and accuracy of mRDTs were 99.75%, 54.54% and 98.57%, respectively. The sensitivity of mRDT was below the WHO recommended sensitivity (>95%), although the specificity (98.78%) was within the WHO recommended specificity (>=90). There was substantial agreement between the mRDT and malaria microscopic test results, k=0.642. Conclusion mRDTs continue to be an appropriate choice for malaria diagnosis in the absence of microscopy.

2021 ◽  
Author(s):  
MSc Field Epi Metuschelah HABIMANA ◽  
NDAHINDWA ◽  
MSc UMUHOZA Stella Matutina ◽  
OMOLO ◽  
MSc Schifra UWAMUNGU ◽  
...  

Abstract Background Currently, malaria rapid diagnostic tests (mRDTs) are increasingly used for diagnosis of malaria, particularly in community where microscopy-based diagnosis is not practical. However, the diagnostic accuracy of mRDTs performed by the community health workers (CHWs) remains unknown. This study was conducted to determine the accuracy of mRDT results performed by CHWs in Ngoma district, eastern province of Rwanda. Method This was a cross sectional prospective study. 420 blood samples of patients self-reported to CHWs for malaria diagnosis were collected and analyzed by CHWs using mRDT and quality control tests were performed by using microscopy as a reference test. The study was conducted from 22nd April to 08th July, 2021. Results Among the 420 patients, 234 (55.71%) were females and 186 (44.29%) were males. Malaria test positivity was 2.62% by using mRDT and 1.67% by using microscopic test. The sensitivity and specificity of mRDT were 85.71% and 98.78% respectively. Negative predictive value, positive predictive value and accuracy of mRDTs were 99.75%, 54.54% and 98.57% respectively. Sensitivity of mRDT was below the WHO recommended sensitivity (>95%) although the specificity (98.78%) was within the WHO recommended specificity (>=90). There was a substantial agreement between mRDT and malaria microscopic test results, k=0.642. Conclusion mRDTs continue to be an appropriate choice for malaria diagnosis in the absence of microscopy.


2021 ◽  
Author(s):  
Metuschelah Habimana ◽  
Vedaste NDAHINDWA ◽  
Matutina Stella UMUHOZA ◽  
Jared OMOLO ◽  
Schifra UWAMUNGU ◽  
...  

Abstract Background Currently, malaria rapid diagnostic tests (mRDTs) are increasingly used for diagnosis of malaria, particularly in community where microscopy-based diagnosis is not practical. However, the diagnostic accuracy of mRDTs performed by the community health workers (CHWs) remains unknown. This study was conducted to determine the accuracy of mRDT results performed by CHWs in Ngoma district, eastern province of Rwanda. Method This was a cross sectional prospective study. 420 blood samples of patients self-reported to CHWs for malaria diagnosis were collected and analyzed by CHWs using mRDT and quality control tests were performed by using microscopy as a reference test. The study was conducted from 22nd April to 08th July, 2021. Results Among the 420 patients, 234 (55.71%) were females and 186 (44.29%) were males. Malaria test positivity was 2.62% by using mRDT and 1.67% by using microscopic test. The sensitivity and specificity of mRDT were 85.71% and 98.78% respectively. Negative predictive value, positive predictive value and accuracy of mRDTs were 99.75%, 54.54% and 98.57% respectively. Sensitivity of mRDT was below the WHO recommended sensitivity (>95%) although the specificity (98.78%) was within the WHO recommended specificity (>=90). There was a substantial agreement between mRDT and malaria microscopic test results, k=0.642. Conclusion mRDTs continue to be an appropriate choice for malaria diagnosis in the absence of microscopy.


2021 ◽  
Author(s):  
Tobius Mutabazi ◽  
Emmanuel Arinaitwe ◽  
Alex Ndyabakira ◽  
Emmanuel Sendaula ◽  
Alex Kakeeto ◽  
...  

Abstract Introduction: Although microscopy remains the gold standard for malaria diagnosis, little is known about its accuracy in the private health facilities in Uganda. We evaluated the accuracy of malaria microscopy, and factors associated with inaccurate smear results at private health facilities in Entebbe Municipality, Uganda.Methods: Between April and May 2018, all patients referred for a malaria smear in 16 private health facilities in Entebbe municipality were screened, and 321 patients were enrolled. A questionnaire was administered to collect demographic and clinical information, facility-based smear results were recorded from the participant’s consultation notes, and a research slide was obtained for expert microscopy. A health facility assessment was conducted, and information on experience in performing malaria microscopy was collected from all facility personnel reading smears and the data was linked to the participant’s clinic visit. Results: The prevalence of malaria parasitemia was 15.0% by expert microscopy. The sensitivity, specificity and negative predictive value of the facility-based microscopy were high (95.8%, 90.1% and 99.2% respectively). However; the positive predictive value (PPV) was low with 27/73 (63%) patients diagnosed with malaria not having the disease. Majority of the inaccurate results were from 2 of the 23 laboratory personnel reading the smears. The factors associated with inaccurate smear readings included being read by a technician; 1) who had less than 5 years’ experience in reading malaria smears (adjusted Odds Ratio [OR] = 9.74, 95% Confidence Interval [CI] (1.06 – 89.5), p-value=0.04), and 2) who was examining less than 5 smears a day (OR = 38.8, 95% CI 9.65- 156, p-value <0.001).Conclusion: The accuracy of malaria microscopy in this setting was high, although one third of the patients diagnosed with malaria did not have the disease. Majority of the errors in smear readings were made by two laboratory personnel, with the main factor associated with inaccurate smear results being low experience in malaria microscopy. In-service training may be sufficient to eliminate inaccurate smear results in this setting, and these private facilities would be ideal model facilities to improve the quality of malaria microscopy in Uganda especially in the public sector.


2021 ◽  
Author(s):  
Bokretsion Gidey ◽  
Desalegn Nega ◽  
Adugna Abera ◽  
Abnet Abebe ◽  
Sindew Mekasha ◽  
...  

Abstract Background: In Ethiopia, malaria cases are declining as a result of proven interventions and in 2017, the country launched a malaria elimination strategy in targeted settings. Accurate malaria diagnosis and prompt treatment are the key components of the strategy to prevent morbidity and stop the continuation of transmission. However, the quality of microscopic diagnosis in general is deteriorating as malaria burden declines. Therefore, this study was carried out to evaluate the competency of microscopists and the performance of health facilities on malaria microscopic diagnosis.Methods: A cross-sectional study was conducted from August 1st to September 30th, 2019 in nine regional states and one city administration. A standard checklist was used for on-site evaluation, archived patient slides were re-checked, and proficiency of microscopists was tested using WHO certified slides from the national slide bank at the Ethiopian Public Health Institute (EPHI). The strength of agreement, the sensitivity, the specificity, and the positive and negative predictive values were calculated.Results: In this study, 102 health facilities (84 health centers and 18 hospitals) were included; from which, 202 laboratory professionals participated. In slide re-checking, moderate agreement (Agreement: 76.0%; Kappa: 0.41) was observed between experts and microscopists on malaria detection in all health facilities. The sensitivity and specificity of routine slide reading and the re-checking results were 78.1% and 80.7%, respectively. Likewise, positive predictive value of 65.1% and negative predictive value of 88.8% were scored in the routine diagnosis. By panel testing, a substantial overall agreement (A: 91.8%; K: 0.79) was observed between microscopists and experts in detecting malaria parasites. The sensitivity and specificity in the detection of malaria parasites was 92.7% and 89.1%, respectively. Furthermore, in identifying species, a slight agreement (A: 57%; K: 0.18) was observed between microscopists and experts. Conclusion: The study found significant false positive and false negative results in routine microscopy on slide re-checking of Plasmodium parasites. Moreover, reduced grade in parasite species identification was reported on the panel tests. Therefore, implementing comprehensive malaria microscopy mentorship, in-service training, and supportive supervision are the key strategies to improve the overall performance of health facilities in malaria microscopy.


2019 ◽  
Author(s):  
Joanne D Stekler ◽  
Lauren R Violette ◽  
Hollie A Clark ◽  
Sarah J McDougal ◽  
Lisa A Niemann ◽  
...  

BACKGROUND HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. OBJECTIVE This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. METHODS Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle &amp; King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. RESULTS Between September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. CONCLUSIONS Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. INTERNATIONAL REGISTERED REPORT RR1-10.2196/16332


2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Abiodun Ogunniyi ◽  
Magbagbeola David Dairo ◽  
Hannah Dada-Adegbola ◽  
Ikeoluwapo O. Ajayi ◽  
Adebola Olayinka ◽  
...  

Background. Unavailability of accurate, rapid, reliable, and cost-effective malaria diagnostic instruments constitutes major a challenge to malaria elimination. We validated alternative malaria diagnostic instruments and assessed their comparative cost-effectiveness. Method. Using a cross-sectional study design, 502 patients with malaria symptoms at selected health facilities in Ibadan between January and April 2014 were recruited consecutively. We examined malaria parasites using Cyscope®, QBC, and CareStart™ and results were compared to light microscopy (LM). Validity was determined by assessing sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Costs per hour of use for instruments and turnaround time were determined. Result. Sensitivity of the instruments was 76.0% (CareStart), 95.0% (Cyscope), and 98.1% (QBC). Specificity was 96.0% (CareStart), 87.3% (Cyscope), and 85.5% (QBC). PPV were 65.2%, 67.5%, and 84.7%, while NPV were 93.6%, 98.6%, and 99.4% for CareStart, Cyscope, and QBC with Kappa values of 0.75 (CI = 0.68–0.82) for CareStart, 0.72 (CI = 0.65–0.78) for Cyscope, and 0.71 (CI = 0.64–0.77) for QBC. Average cost per hour of use was the lowest ($2.04) with the Cyscope. Turnaround time was the fastest with Cyscope (5 minutes). Conclusion. Cyscope fluorescent microscope had the shortest turnaround time and is the most cost-effective of all the malaria diagnostic instruments evaluated.


2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Tobius Mutabazi ◽  
Emmanuel Arinaitwe ◽  
Alex Ndyabakira ◽  
Emmanuel Sendaula ◽  
Alex Kakeeto ◽  
...  

Abstract Background Although microscopy remains the gold standard for malaria diagnosis, little is known about its accuracy in the private health facilities in Uganda. This study evaluated the accuracy of malaria microscopy, and factors associated with inaccurate smear results at private health facilities in Entebbe Municipality, Uganda. Methods Between April and May 2018, all patients referred for a malaria smear in 16 private health facilities in Entebbe municipality were screened, and 321 patients were enrolled. A questionnaire was administered to collect demographic and clinical information, facility-based smear results were recorded from the participant’s consultation notes, and a research slide was obtained for expert microscopy during exit interview. A health facility assessment was conducted, and information on experience in performing malaria microscopy was collected from all facility personnel reading smears and the data was linked to the participant’s clinic visit. Results The test positivity rate of malaria parasitaemia was 15.0% by expert microscopy. The sensitivity, specificity and negative predictive value of the facility-based microscopy were high (95.8%, 90.1 and 99.2%, respectively). However; the positive predictive value (PPV) was low with 27/73 (63%) patients diagnosed with malaria not having the disease. Majority of the inaccurate results were from 2 of the 23 laboratory personnel reading the smears. The factors associated with inaccurate smear readings included being read by a technician; (1) who had less than 5 years’ experience in reading malaria smears (adjusted Odds Ratio [aOR] = 9.74, 95% confidence interval [CI] (1.06–89.5), p-value = 0.04), and (2) who was examining less than 5 smears a day (aOR = 38.8, 95% CI 9.65–156, p-value < 0.001). Conclusions The accuracy of malaria microscopy in this setting was high, although one third of the patients diagnosed with malaria did not have the disease. Majority of the errors in smear readings were made by two laboratory personnel, with the main factor associated with inaccurate smear results being low experience in malaria microscopy. In-service training may be sufficient to eliminate inaccurate smear results in this setting, and these private facilities would be ideal model facilities to improve the quality of malaria microscopy in Uganda especially in the public sector where accuracy is still poor.


2016 ◽  
Vol 55 (1) ◽  
pp. 253-263 ◽  
Author(s):  
Wellington A. Oyibo ◽  
Nnenna Ezeigwe ◽  
Godwin Ntadom ◽  
Oladipo O. Oladosu ◽  
Kaitlin Rainwater-Loveth ◽  
...  

ABSTRACTThe need to expand malaria diagnosis capabilities alongside policy requirements for mandatory testing before treatment motivates exploration of noninvasive rapid diagnostic tests (RDTs). We report the outcome of the first cross-sectional, single-blind clinical performance evaluation of a urine malaria test (UMT) for diagnosis ofPlasmodium falciparummalaria in febrile patients. Matched urine and finger-prick blood samples from participants ≥2 years of age with fever (axillary temperature of ≥37.5°C) or with a history of fever in the preceding 48 h were tested with UMT and microscopy (as the gold standard). BinaxNOW (Pf and Pan versions) blood RDTs were done to assess relative performance. Urinalysis and rheumatoid factor (RF) tests were conducted to evaluate possible interference. Diagnostic performance characteristics were computed at 95% confidence intervals (CIs). Of 1,800 participants screened, 1,691 were enrolled; of these 566 (34%) were febrile, and 1,125 (66%) were afebrile. Among enrolled participants, 341 (20%) tested positive by microscopy, 419 (25%) were positive by UMT, 676 (40%) were positive by BinaxNOW Pf, and 368 (22%) were positive by BinaxNow Pan. UMT sensitivity among febrile patients (for whom the test was indicated) was 85%, and specificity was 84%. Among febrile children ≤5 years of age, UMT sensitivity was 93%, and specificity was 83%. The area under the receiver-operator characteristic curve (AUC) of UMT (0.84) was not significantly different from that of BinaxNOW Pf (0.86) or of BinaxNOW Pan (0.87), indicating that the tests do not differ in overall performance. Gender, seasons, and RF did not impact UMT performance. Leukocytes, hematuria, and urobilinogen concentrations in urine were associated with lower UMT specificities. UMT performance was comparable to that of the BinaxNOW Pf/Pan tests, making UMT a promising tool to expand malaria testing in public and private health care settings where there are challenges to blood-based malaria diagnosis testing.


2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Bokretsion Gidey ◽  
Desalegn Nega ◽  
Adugna Abera ◽  
Abnet Abebe ◽  
Sindew Mekasha ◽  
...  

Abstract Background In Ethiopia, malaria cases are declining as a result of proven interventions, and in 2017 the country launched a malaria elimination strategy in targeted settings. Accurate malaria diagnosis and prompt treatment are the key components of the strategy to prevent morbidity and stop the continuation of transmission. However, the quality of microscopic diagnosis in general is deteriorating as malaria burden declines. This study was carried out to evaluate the competency of microscopists and the performance of health facilities on malaria microscopic diagnosis. Methods A cross-sectional study was conducted from 1 August to 30 September, 2019 in 9 regional states and one city administration. A standard checklist was used for on-site evaluation, archived patient slides were re-checked and proficiency of microscopists was tested using a WHO-certified set of slides from the national slide bank at the Ethiopian Public Health Institute (EPHI). The strength of agreement, sensitivity, specificity, and positive and negative predictive values were calculated. Results In this study, 102 health facilities (84 health centres and 18 hospitals) were included, from which 202 laboratory professionals participated. In slide re-checking, moderate agreement (agreement (A): 76.0%; Kappa (K): 0.41) was observed between experts and microscopists on malaria detection in all health facilities. The sensitivity and specificity of routine slide reading and the re-checking results were 78.1 and 80.7%, respectively. Likewise, positive predictive value of 65.1% and negative predictive value of 88.8% were scored in the routine diagnosis. By panel testing, a substantial overall agreement (A: 91.8%; K: 0.79) was observed between microscopists and experts in detecting malaria parasites. The sensitivity and specificity in the detection of malaria parasites was 92.7 and 89.1%, respectively. In identifying species, a slight agreement (A: 57%; K: 0.18) was observed between microscopists and experts. Conclusion The study found significant false positive and false negative results in routine microscopy on slide re-checking of Plasmodium parasites. Moreover, reduced grade in parasite species identification was reported on the panel tests. Implementing comprehensive malaria microscopy mentorship, in-service training and supportive supervision are key strategies to improve the overall performance of health facilities in malaria microscopy.


2021 ◽  
Vol 5 (1) ◽  
pp. 20
Author(s):  
Lia Woro Andini

Wanita menjelang menopause akan mengalami penurunan berbagai fungsi tubuh, sehingga akan berdampak pada ketidaknyamanan dalam menjalani kehidupannya. Untuk itu diperlukan sikap positif dengan diimbangi oleh informasi atau pengetahuan yang cukup, sehingga wanita lebih siap dalam menghadapi menopause baik siap secara fisik, mental, dan spiritual. Kesiapan sangat penting dimiliki wanita menjelang menopause baik pada wanita yang bekerja maupun yang tidak bekerja namun sejauh ini masih sedikit laporan terkait perbedaan tingkat kesiapan menghadapi menopause antara wanita yang bekerja dengan yang tidak bekerja. Tujuan Penelitian: mengetahui perbedaan tingkat kesiapan menghadapi menopause antara wanita yang bekerja dengan yang tidak bekerja. Metode: Penelitian ini menggunakan desain komparatif dengan pendekatan cross-sectional. Teknik pengambilan sampel menggunakan teknik purposive sampling dengan jumlah sampel 57 responden. Instrumen penelitian ini adalah kuesioner kesiapan menghadapi menopause yang diadopsi dari penelitian Hidayatiningtyas yang valid dan reliabel. Hasil penelitian dianalisis dengan menggunakan uji Mann Whitney. Hasil: 58,6% wanita tidak bekerja memiliki kesiapan cukup dan 27,6% memiliki kesiapan kurang. Sedangkan pada wanita yang bekerja, 60% memiliki kesiapan cukup dan 32,1% memiliki kesiapan baik. Ada perbedaan bermakna pada kesiapan menghadapi menopause antara wanita yang bekerja dengan yang tidak bekerja (p=0,022). Diskusi: Pada wanita yang bekerja memiliki kesiapan yang lebih baik dibandingkan dengan wanita yang tidak bekerja.  Hal ini karena wanita yang bekerja cenderung memiliki pandangan dan cara berpikir yang lebih luas sehingga akan memiliki pengetahuan yang cukup, salah satunya dalam hal kesiapan menghadapi menopause.  Kesimpulan: Petugas kesehatan disarankan dapat memberikan pendidikan kesehatan dalam rangka menyiapkan wanita pra menopause menghadapi masa menopause.  Bagi wanita, khususnya yang tidak bekerja, diharapkan mempersiapkan diri menghadapi menopause dengan aktif mencari informasi.Kata Kunci: Menopause, wanita bekerja Differences in Menopause Readiness Levels Between Working and Non-Working WomenABSTRACTMenopause-approaching women will experience a decrease in various body functions, which will cause discomfort in living their lives. Therefore, it requires a balance between a positive attitude and sufficient information or knowledge so that women are better prepared to face menopause physically, mentally, and spiritually. Readiness is crucial for women before menopause, both for working and non-working women. However, to date, there are few reports related to differences in the levels of readiness to face menopause between working and non-working women. Objective: to reveal the difference in readiness levels to face menopause between working and non-working women. Methods: This research employed a comparative design with a cross-sectional approach. Samples were taken using the purposive sampling technique with a sample size of 57 respondents. The instrument used in this research was a valid and reliable questionnaire of readiness to face menopause adopted from Hidayatiningtyas. The results of the research were analyzed using the Mann-Whitney test. Results: 58.6% of non-working women had sufficient readiness and 27.6% had insufficient readiness. Meanwhile, 60% of working women had sufficient readiness and 32.1% had good readiness. There was a significant difference in readiness to face menopause between working and non-working women (p = 0.022). Discussion: Working women are more prepared to face menopause than non-working women. This is because working women tend to have broader views and ways of thinking so that they will have sufficient knowledge, one of which is in terms of readiness to face menopause.  Conclusion: It is advised that health workers provide health education to prepare pre-menopausal women to face menopause. Moreover, it is expected that women, particularly those who do not work, prepare for menopause by actively seeking information.Keywords: Menopause, working women


Sign in / Sign up

Export Citation Format

Share Document