Reference Intervals for Common Renal and Liver Function Clinical Chemistry Parameters Among Apparently Healthy Pregnant and Non-pregnant Women in South Wollo Zone, Amhara National Regional State, Northeast Ethiopia.

Background: Physiological changes during pregnancy cause alterations in concentration of biochemical analytes. Thus, locally established pregnancy-specific reference intervals are important for accurate diagnosis, treatment, and prognosis of diseases. The objective of the study was to establish reference interval for the common renal and liver function clinical chemistry parameters among pregnant and non-pregnant women of South Wollo zone, Ethiopia. Methods: A community-based cross-sectional study was conducted on a total of 323 apparently healthy study participants randomly selected from South Wollo zone, Ethiopia, from April to June 2019. Medical history, physical examination and sociodemography were collected by using questionnaire. Liver and renal function clinical chemistry tests were done using A25 Biosystems, clinical chemistry analyzer. After the exclusion of outliers, Kolmogorov-Smirnov test was used to check its normality. The 95% RI with 95% confidence interval was established using the nonparametric method. The significance of differences was evaluated using Mann-Whitney U test. Result: There was statistically significant variation between pregnant and non-pregnant women in values of albumin, T. protein, ALP, urea and creatinine, but not for AST, ALT, bilirubin (direct) and bilirubin (total). Reference intervals established for pregnant women includes albumin 26.14-42.87g/L, total protein 48.52-74.71 g/L, AST 2.4-43.6 U/L, ALT 0.94-28.35 U/L, ALP 21.2-337 U/L, bilirubin (direct) 0.03-0.32 mg/dL, bilirubin (total) 0.26-0.94 mg/dL, creatinine 0.29-0.87 mg/dL, urea 7.17-20.82 mg/dL. Albumin: 32.81-47.87, total protein: 56.71-83.9 U/L, AST: 4.2-37.1 U/L, ALT: 2.69-41.18 U/L, ALP: 3.22-278.7 U/L, bilirubin (direct) 0.1-0.51 mg/dL, bilirubin (total) 0.24-1.06 mg/dL, creatinine 0.44-1.00 mg/dL, urea 8.07-27.87 mg/dL for non-pregnant women. Conclusion: The study showed marked difference in albumin, total protein, alkaline phosphatase, urea and creatinine. Therefore, physiological adaptations of pregnancy should be considered when interpreting liver and renal function tests in a pregnant woman.

Household knowledge, practice and treatment seeking behaviors towards cutaneous leishmaniasis in the endemic rural communities of Ganta- afeshum district, Tigrai, northern Ethiopia, 2019: a cross-sectional study.

BACKGROUND: Cutaneous leishmaniasis is endemic to Ethiopia. However, the prevention and control efforts of leishmaniasis remain unfocused with clear knowledge and practice gaps within the country. Thus, a house to house survey has been carried out to assess the knowledge, practice and treatment-seeking behavior of households towards cutaneous leishmaniasis in the rural communities of Tigrai region, northern Ethiopia. METHODS: A community-based cross-sectional house-to-house survey was conducted in two selected rural villages of Ganta-afeshum district, Tigrai, northern Ethiopia in 2019. A simple random sampling technique was employed to select the participants. Household heads were interviewed using a pre-tested semi-structured questionnaire. Epi info version 7.0 was used for data entry and the data were imported to SPSS version 23 for analysis. Chi-square test (χ2) was used to test the association between the independent variables and the knowledge and practice status of the study participants. P-value < 0.05 was used to declare a statistically significant association among the variables. RESULTS: In our study, most of the participants (78%) stated that cutaneous leishmaniasis is a health problem in the area. Three hundred eighty (99.5%) participants responded that the most common clinical presentation of cutaneous leishmaniasis is a lesion on the face. All of the study participants did not know the mode of cutaneous leishmaniasis transmission, and had never heard of the sand fly. A majority of the participants were unaware of the main prevention methods for cutaneous leishmaniasis. Lastly, traditional medicine was used in 90% of the study households with a previous history for cutaneous leishmaniasis. CONCLUSION: There is a lack of awareness regarding the transmission of cutaneous leishmaniasis in Ganta-afeshum, Ethiopia, where the majority of individuals are unfamiliar with the sand fly vector. Prevention methods for cutaneous leishmaniasis were unavailable among the community. Therefore, health education programs concerning cutaneous leishmaniasis transmission, prevention, and treatment in the area should be rigorously implemented.

Epidemiology and sex differences of podoconiosis in Ethiopia: A systemic review and meta-analysis.

OBJECTIVES: Podoconiosis is a poorly understood neglected tropical disease which results in a high socio-economic burden. In Ethiopia, despite the high prevalence, morbidity, and socio-economic impacts, little information is available about the disease. Thus, this review aimed to assess the effect of sex differences and pooled prevalence of podoconiosis in Ethiopia. STUDY SETTING: Ethiopia is a country located in East Africa. METHODS: Published literature on the prevalence of podoconiosis in Ethiopia was searched through MEDLINE/PubMed, Cochrane Library, Goggle scholar, and Global Health. Studies conducted in humans, open access, and met 50% threshold on the quality assessment checklist score adopted from Joanna Briggs Institute were eligible for inclusion. Data were extracted using first author, year of publication, participants' population, setting (urban/rural), study design, podoconiosis infection among males, the total number of males, podoconiosis infection among females, the total number of females, and context using Microsoft™ Excel. R statistical software version 3.6.1 was utilized to carry out the meta-analysis. The protocol of this review is registered in the PROSPERO international prospective register of systematic reviews and assigned a registration number of CRD 42020154697. RESULTS: We performed heterogeneity, sensitivity, and publication bias analysis for the included articles. We identified 229 records, of which 11 studies met the inclusion criteria. The pooled prevalence of podoconiosis in Ethiopia was 6% [95% CI: 5%; 6%]. Subgroup analysis by setting indicated slightly higher prevalence in rural settings. The odds of podoconiosis infection among female is 1.15 times that of males" The effect of sex on podoconiosis was sub-grouped by study setting and the odds of females were 1.29 times at increased risk of acquiring podoconiosis than males (p < 0.01) in rural settings. CONCLUSIONS: The prevalence of podoconiosis in Ethiopia is high. This review suggested that females are at higher risk of developing podoconiosis than males, particularly in rural communities which has health promotion and awareness implications regarding protective wear.

Assessment of knowledge, practice, and status of food handlers toward Salmonella, Shigella, and intestinal parasites: A cross-sectional study in Tigrai prison centers, Ethiopia.

BACKGROUND: Unsafe food becomes a global public health and economic threat to humans. The health status, personal hygiene, knowledge, and practice of food handlers have crucial impact on food contamination. Hence, this study is aimed at assessing the knowledge, practice, and prevalence of Salmonella, Shigella, and intestinal parasites among food handlers in Eastern Tigrai prison centers, Northern Ethiopia. METHODS: An institutional-based cross-sectional study was carried out from April to September 2019 among food handlers in Eastern Tigrai prison centers, Northern Ethiopia. A structured questionnaire was used to collect the demographic characteristics, the knowledge, and the practice of the study participants. Direct wet mount and formol-ether concentration techniques were applied to identify intestinal parasites. Culture and biochemical tests were used to isolate the Salmonella and the Shigella species. Additionally, antimicrobial susceptibility tests to selected antibiotics were performed using Kirby-Baur disk diffusion method. We used SPSS version 23 software for statistical analysis. RESULTS: Thirty-seven (62.7%, 37/59) of the participants had harbored one or more intestinal parasites. The protozoan Entamoeba histolytica/dispar was detected among 23.7% (14/59) of the study participants who provided stool specimen. Besides, 6.8% (4/59) of the samples were positive for either Salmonella or Shigella species. The Salmonella isolates (n = 2) were sensitive to Gentamicin, Ciprofloxacin, Ceftriaxone, and Clarithromycin but resistant to Amoxicillin, Ampicillin, and Amoxicillin/clavulanic acid. Similarly, the two Shigella isolates were susceptible to Gentamicin, Ciprofloxacin, and Ceftriaxone but showed resistance to Amoxicillin, Tetracycline, and Chloramphenicol. Further, 60.6% (40/66) of the participants had good level of knowledge, and 51.5% (34/66) had good level of practice on foodborne diseases and on food safety. CONCLUSIONS: We conclude that foodborne pathogens are significant health problems in the study areas. Regular health education and training programs among the food handlers are demanded to tackle foodborne diseases at the prison centers.

Community based hematological reference intervals among apparently healthy adolescents aged 12-17 years in Mekelle city, Tigrai, northern Ethiopia: A cross sectional study.

BACKGROUND: Hematological reference intervals are important in clinical and diagnostic management for the assessment of health and disease conditions. Hematological reference intervals are better to be established based on gender and age differences as these are among the main affecting factors. OBJECTIVE: The aim of this study was to establish hematological reference intervals among apparently healthy adolescents aged 12-17 years in Mekelle City, Tigrai, Northern Ethiopia, 2019. METHOD: A community-based cross-sectional study was conducted in 249 adolescents aged 12-17 years from December 2018 to May 2019. About 4ml of blood sample was collected from each study participant using vacutainer tube containing K2EDTA. Hematological parameters were analyzed using Sysmex KX-21N hematology analyzer (Sysmex Corporation Kobe, Japan). Data were entered and analyzed using SPSS version 23. Both parametric and non-parametric analyses were used to calculate the median and 95% of reference intervals. The 97.5th and 2.5th percentiles were calculated using descriptive statistics for the upper and lower reference limits of the study participants. Differences in reference intervals between male and female participants were evaluated using the Mann-Whitney U test. RESULT: Among the 249 participants 122 (49%) were males and 127 (51%) were females with the median age of 14.5 (range 12 to 17) years were recruited in this study. The median and the 95% reference intervals of hematological parameters were determined. The 95% RIs were: Red blood cells (1012/Liter) 4.6-5.9 (Males) and 4.3-5.6 (Females), White blood cells (109/Liter) 2.9-9.6 (Males) and 3.4-10.2 (Females), Hemoglobin (g/dl) 12.6-17.1 (Males) and 12-15.4 (Females), Platelets (109/Liter) 138-364 (Males) and 151-462 (Females). Almost all of the hematological parameters showed significant differences (p<0.05) across gender. CONCLUSION: The hematological reference intervals established in this study showed a difference based on gender. We suggest preparing and using distinct local reference intervals for males and females separately.

Alteration of Clinical Chemistry Parameters Among Visceral Leishmaniasis Patients in Western Tigrai, Ethiopia, 2018/2019: A Comparative Cross-Sectional Study.

BACKGROUND: Visceral leishmaniasis causes alterations of lipid metabolism and it is associated with hypocholesterolemia and severe hypertriglyceridemia. Hepatic dysfunction and life-threatening hepatitis are associated with visceral leishmaniasis. Kidney damage is frequently associated with increased morbidity and mortality in visceral leishmaniasis patients. METHODS: A cross-sectional study was carried out to assess the alterations of clinical chemistry parameters among visceral leishmaniasis patients attending Kahsay Abera and Mearg hospitals, Northwest Ethiopia. A total of 100 visceral leishmaniasis patients and 100 healthy controls without visceral leishmaniasis were selected by using convenient sampling techniques. Data were entered and analyzed using statistical package for social sciences (SPSS) version 23. RESULTS: Results were showed that the mean value of serum aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, and triglyceride was significantly higher in visceral leishmaniasis patients than in apparently healthy controls, but the mean value of serum urea and total cholesterol was significantly lower in visceral leishmaniasis patients than healthy controls. CONCLUSION: The finding of this study concluded that visceral leishmaniasis causes significant alterations of clinical chemistry tests like liver and lipid profile tests compared to healthy controls.

Community based reference interval of selected clinical chemistry parameters among apparently healthy Adolescents in Mekelle City, Tigrai, Northern Ethiopia.

BACKGROUND: Locally established clinical laboratory reference intervals (RIs) are required to interpret laboratory test results for screening, diagnosis and prognosis. The objective of this study was establishing reference interval of clinical chemistry parameters among apparently healthy adolescents aged between 12 and 17 years in Mekelle, Tigrai, northern part of Ethiopia. METHODS: Community based cross sectional study was employed from December 2018 to March 2019 in Mekelle city among 172 males and 172 females based on Multi stage sampling technique. Blood samples were tested for Fasting blood sugar (FBS), alanine aminino transferase (ALT), aspartate amino transferase (AST), alkaline phosphatase (ALP), Creatinine, urea, total protein, albumin (ALB), direct and indirect bilirubin (BIL.D and BIL.T) using 25 Bio system clinical chemistry analyzer. Results were analyzed using SPSS version 23 software and based on the Clinical Laboratory Standard Institute (CLSI)/ International Federation of Clinical Chemistry (IFCC) C 28-A3 Guideline which defines the reference interval as the 95% central range of 2.5th and 97.5th percentiles. Mann Whitney U test, descriptive statistics and box and whisker were statistical tools used for analysis. RESULTS: This study observed statistically significant differences between males and females in ALP, ALT, AST, Urea and Creatinine Reference intervals. The established reference intervals for males and females, respectively, were: ALP (U/L) 79.48-492.12 versus 63.56-253.34, ALT (U/L) 4.54-23.69 versus 5.1-20.03, AST 15.7-39.1 versus 13.3-28.5, Urea (mg/dL) 9.33-24.99 versus 7.43-23.11, and Creatinine (mg/dL) 0.393-0.957 versus 0.301-0.846. The combined RIs for Total Protein (g/dL) was 6.08-7.85, ALB (g/dL) 4.42-5.46, FBS(mg/dL) 65-110, BIL.D (mg/dL) 0.033-0.532, and BIL.T (mg/dL) 0.106-0.812. CONCLUSIONS: The result showed marked difference among sex and with the company derived values for selected clinical chemistry parameters. Thus, use of age and sex specific locally established reference intervals for clinical chemistry parameters is recommended.

Nocardiosis in HIV seropositive clinically suspected pulmonary tuberculosis patients.

To determine the frequency of nocardiosis in HIV-positive individuals clinically suspected of having tuberculosis (TB), 140 sputum samples were collected and processed by Gram stain, modified Ziehl-Neelsen staining and by culture on Lowenstein Jensen medium. Four (2.85%) patients were positive for nocardia by microscopy and five (3.6%) had positive culture for Nocardia asterioides. In areas where HIV-associated TB is common, some patients diagnosed as smear-negative pulmonary TB will actually have nocardiosis. Clinicians should be aware of this entity in HIV/immunocompromised patients with respiratory infections who fail to respond to antituberculous treatment.

Factors Affecting Quality of Laboratory Services in Public and Private Health Facilities in Addis Ababa, Ethiopia.

BACKGROUND: Quality laboratory service is an essential component of health care system but in Sub-Saharan Africa such as Ethiopia, laboratories quality system remains weak due to several factors and it needs more attention to strengthen its capacity and quality system. METHODOLOGY: A cross sectional study was conducted using a questionnaire to assess factors affecting the quality of laboratory service at private and public health institutions in Addis Ababa. RESULTS: A total of 213 laboratory professionals participated in the study and 131 (61.5%) participants had bachelor degree. Majority, 133 (62.4%), of the professionals did not attend any work related training. Seventy five (35.2%) respondents believed that their laboratories did not provide quality laboratory services and the major reported factors affecting provision of quality services were shortage of resources (64.3%), poor management support (57.3%), poor equipment quality (53.4%), high workload (41.1%), lack of equipment calibration (38.3%) and lack of knowledge (23.3%). Moreover logistic regression analysis showed that provision of quality laboratory service was significantly associated with result verification (AOR=9.21, 95% CI=2.26, 37.48), internal quality control (AOR= 6.11, 95% CI=2.11, 17.70), turnaround time (AOR=5.11, 95% CI=1.94, 13.46), shortage of equipment (AOR=7.76, 95% CI=2.55, 23.66), communication with clinicians (AOR=3.24, 95% CI=1.25, 8.41) and lack of job description (AOR=3.67, 95% CI=1.319, 10.22). CONCLUSION: In conclusion, the major factors that affecting the quality of laboratory service were associated with poor human resource management, poor resources provision, poor management commitment, ineffective communication system and lack of well-established quality management system.

Implementation and Evaluation of a Blended Learning Course on Tuberculosis for Front-Line Health Care Professionals.

OBJECTIVES: To implement and evaluate the effectiveness of a 10-module blended learning course on tuberculosis diagnosis for Ethiopian health care professionals. METHODS: This implementation science research was conducted within the routine in-service training for health care professionals in Ethiopia. A combined web-based and face-to-face acid-fast bacilli microscopy course was designed and its applicability studied after 6 weeks of enrollment of 108 medical laboratory professionals. A survey was conducted to capture participants' feedback on the course. RESULTS: Of 108 participants enrolled, 81 attended and 73 (90%) completed the course; 72 (94%) had no experience taking online courses. Mean percentages of quizzes, assignments/exercises, and hands-on scores were 88%, 70%, and 95%, respectively. No significant differences were found in scores between participants from public, private, and nongovernmental health facilities ( P = .386) or between higher and lower level facilities ( P = .533). Participants' overall satisfaction with the course was 88%. CONCLUSIONS: Blended learning was an effective pedagogic approach for this category of professionals because of the crucial need for hands-on training for practicing and translating knowledge into skills. This approach also had the advantages of keeping the costs of the entire course low and reaching a greater number of participants, all without significant disruption of work schedules.

Progress and Challenges for Implementation of the Common Market for Eastern and Southern Africa Policy on Biotechnology and Biosafety.

In 2001, the Meeting of the COMESA Ministers of Agriculture raised concerns that proliferation of genetically modified organisms (GMOs) could impact significantly on trade and food security in the region. This triggered studies on a regional approach to biotechnology and biosafety policy in Eastern and Southern Africa. The studies and stakeholder consultations revealed that farm incomes would increase if they switched from conventional varieties of cotton and maize to genetically modified (GM) counterparts. Commercial risks associated with exports to GM sensitive destinations, e.g., EU were negligible. Intra-regional trade would be affected since exports of GM sensitive commodities, such as maize, cotton, and soya bean, mainly go to other African countries. These findings justified the need to consider a regional approach to biosafety and led to the drafting of a regional policy in 2009. The draft policies were discussed in regional and national workshops between 2010 and 2012 for wider ownership. The workshops involved key stakeholders including ministries of agriculture, trade, environment, national biosafety focal points, biosafety competent authorities, academia, seed traders, millers, the media, food relief agencies, the industry, civil society, competent authorities, and political opinion leaders. The COMESA Council of Ministers in February 2014 adopted the COMESA policy on biotechnology and biosafety that takes into account the sovereign right of each member state. Key provisions of the policy include recognition of the benefits and risks associated with GMOs; establishment of a regional-level biosafety risk-assessment system; national-level final decision, and capacity building assistance to member states. The policies are the first regional effort in Africa to develop a coordinated mechanism for handling biosafety issues related to GMO use. A regional approach to biotechnology and biosafety is expected to foster inter-country cooperation through the sharing of knowledge, expertise, experiences, and resources.

The status of medical laboratory towards of AFRO-WHO accreditation process in government and private health facilities in Addis Ababa, Ethiopia.

INTRODUCTION: The World Health Organization Regional Office for Africa (WHO AFRO) introduces a step wise incremental accreditation approach to improving quality of laboratory and it is a new initiative in Ethiopia and activities are performed for implementation of accreditation program. METHODS: Descriptive cross sectional study was conducted in 30 laboratory facilities including 6 laboratory sections to determine their status towards of accreditation using WHO AFRO accreditation checklist and 213 laboratory professionals were interviewed to assess their knowledge on quality system essentials and accreditation in Addis Ababa Ethiopia. RESULTS: Out of 30 laboratory facilities 1 private laboratory scored 156 (62%) points, which is the minimum required point for WHO accreditation and the least score was 32 (12.8%) points from government laboratory. The assessment finding from each section indicate that 2 Clinical chemistry (55.2% & 62.8%), 2 Hematology (55.2% & 62.8%), 2 Serology (55.2% & 62.8%), 2 Microbiology (55.2% & 62.4%), 1 Parasitology (62.8%) & 1 Urinalysis (61.6%) sections scored the minimum required point for WHO accreditation. The average score for government laboratories was 78.2 (31.2%) points, of these 6 laboratories were under accreditation process with 106.2 (42.5%) average score, while the private laboratories had 71.2 (28.5%) average score. Of 213 respondents 197 (92.5%) professionals had a knowledge on quality system essentials whereas 155 (72.8%) respondents on accreditation. CONCLUSION: Although majority of the laboratory professionals had knowledge on quality system and accreditation, laboratories professionals were not able to practice the quality system properly and most of the laboratories had poor status towards the WHO accreditation process. Thus government as well as stakeholders should integrate accreditation program into planning and health policy.

Antiretroviral treatment associated hyperglycemia and dyslipidemia among HIV infected patients at Burayu Health Center, Addis Ababa, Ethiopia: a cross-sectional comparative study.

BACKGROUND: The effects of highly active antiretroviral therapy (HAART) on glucose and lipid metabolism among sub-Saharan Africans, for whom access to antiretroviral therapy is expanding, remain largely unknown. Therefore, the aim of this study was to assess antiretroviral treatment associated hyperglycemia and dyslipidemia among HIV infected patients at Burayu health center, Addis Ababa, Ethiopia. METHODS: A cross-sectional comparative study was conducted among HIV infected adults at Burayu Health Center, Addis Ababa, Ethiopia from September, 2011 to May, 2012. Equal number of HAART naïve and HAART initiated patients (n = 126 each) were included in the study. Demographic data were collected using a well-structured questionnaire. Total cholesterol (TC), Triglyceride (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) and glucose were determined. The data were analyzed using SPSS version 20 software. RESULT: Of 252 study participants, 72.2% were females; mean age was 35.3 years; mean Body Mass Index (BMI) was 21.4(kg/m2); mean time living with the virus was 20.6 months and 15.5% were TB-HIV co-infected. The prevalence of hyperglycemia, increased LDL-C hypercholesterolemia, hypertriglyceridemia and decreased HDL-C were 7.9%, 23%, 42.1%, 46.8% and 50.8% in HAART and 5.6%, 7.1%, 11.1%, 31% and 73% in non-HAART groups, respectively. First line antiretrovirals were drugs containing 2 nucleoside backbones (from Zidovudine/Stavudine/Lamivudine/Tenofovir) with either Nevirapine or Efavirenz. There was statistically significant increase in serum lipid profile levels among HAART initiated patients than HAART naïve individuals (p =0.01 for TG and <0.001 for others). CONCLUSION: First-line HAART is associated with potentially atherogenic lipid profile levels in patients with HIV infection compared to untreated patients. This indicates glucose and lipid profile levels need to be monitored regularly in HIV infected patients taking antiretroviral treatment.

Assessment of laboratory logistics management information system practice for HIV/AIDS and tuberculosis laboratory commodities in selected public health facilities in Addis Ababa, Ethiopia.

INTRODUCTION: Logistics management information system for health commodities remained poorly implemented in most of developing countries. To assess the status of laboratory logistics management information system for HIV/AIDS and tuberculosis laboratory commodities in public health facilities in Addis Ababa. METHODS: A cross-sectional descriptive study was conducted from September 2010-January 2011 at selected public health facilities. A stratified random sampling method was used to include a total of 43 facilities which, were investigated through quantitative methods using structured questionnaires interviews. Focus group discussion with the designated supply chain managers and key informant interviews were conducted for the qualitative method. RESULTS: There exists a well-designed logistics system for laboratory commodities with trained pharmacy personnel, distributed standard LMIS formats and established inventory control procedures. However, majority of laboratory professionals were not trained in LMIS. Majority of the facilities (60.5%) were stocked out for at least one ART monitoring and TB laboratory reagents and the highest stock out rate was for chemistry reagents. Expired ART monitoring laboratory commodities were found in 25 (73.5%) of facilities. Fifty percent (50%) of the assessed hospitals and 54% of health centers were currently using stock/bin cards for all HIV/AIDS and TB laboratory commodities in main pharmacy store, among these only 25% and 20.8% of them were updated with accurate information matching with the physical count done at the time of visit for hospitals and health centers respectively. CONCLUSION: Even though there exists a well designed laboratory LMIS, keeping quality stock/bin cards and LMIS reports were very low. Key ART monitoring laboratory commodities were stock out at many facilities at the day of visit and during the past six months. Based on findings, training of laboratory personnel's managing laboratory commodities and keeping accurate inventory control procedures were recommended.

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 100x 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.