Whole Blood Stimulation Assay as a Treatment Outcome Monitoring Tool for VL Patients in Ethiopia: A Pilot Evaluation.

Visceral leishmaniasis (VL) is a lethal disease if left untreated. Current treatments produce variable rates of treatment failure and toxicity without sterile cure, rendering treatment efficacy monitoring essential. To avoid repeated invasive tissue aspirates as well as empirical treatment, there is a need for new tools that allow a less-invasive and early assessment of treatment efficacy in the field. Cross-sectional studies have suggested levels of cytokines/chemokines after whole blood stimulation as good markers of cure, but longitudinal studies are lacking. In this study, we followed 13 active VL cases in an endemic area in Ethiopia by measuring the production of IFN-γ, TNF-α, IP-10, IL-2, IL-10, MCP-1, and MIG before, during, and at the end of treatment. After 24 hours of stimulation of whole blood with soluble Leishmania antigen, we observed an early, robust, and incremental increase of IFN-γ, TNF-α, and IP-10 levels in all patients during treatment. Moreover, based on the IFN-γ levels that showed an average 13-fold increase from the time of diagnosis until the end of treatment, we could almost perfectly discriminate active from cured status. Similar concentrations and patterns were found in stimulation assays with the two main Leishmania species. The levels of IFN-γ, IP-10, or TNF-α also seemed to be inversely associated with the parasite load at baseline. Despite a 1/10 drop in concentrations, similar patterns were observed in IFN-γ and IP-10 levels when dried plasma spots were stored at 4°C for an average of 225 days. All the above evidence suggests a detectable restoration of cell-mediated immunity in VL and its association with parasite clearance. With a potential application in rural settings by means of dried plasma spots, we recommend to further explore the early diagnostic value of such assays for treatment efficacy monitoring in large cohort studies including treatment failure cases.

Seroprevalence and associated risk factors for HIV, Hepatitis B and C among blood Donors in South Gondar District blood Bank, Northwest Ethiopia.

BACKGROUND: Despite the undeniable significance of blood transfusion in saving a millions life in emergencies and medical treatment, the quality of blood faced challenges from transfusion-transmitted infections (TTIs) such as HIV (human immunodeficiency virus), HBV (hepatitis B virus) and HCV (hepatitis C virus). This cross-sectional study was undertaken with the aim of determining the seroprevalence and risk factors of HIV, HBV, and HCV among blood donors. METHODS: An institutional based cross-sectional study was conducted at Debre Tabor district hospital from January 2017 to February 2018. Blood samples from volunteer donors collected; serum separated and screened with ELISA tests for detection of anti-HIV, hepatitis-B surface antigen (HBsAg) and anti-HCV. Fishers' exact test was employed to see the association between variables as well logistic regression tests were applied to identify potential risk factors. P-value of less than 0.05 was considered as statistically significant. RESULT: A total of 310 volunteer donors were included in the study. The proportion of blood donors having at least one viral-TTI was 12.6% while the magnitudes of HIV, HBV, and HCV were 2.6, 5.8 and 4.2%, respectively. Educational status and multiple sexual behaviors are significantly associated with HIV acquisition whilst marital status was significantly associated with HBsAg seropositivity. CONCLUSION: Seroprevalence of transfusion-transmissible infections was high and alarming therefore proper screening of donated blood with test methods having better diagnostic performance should be employed. Also encouragement of blood donation from voluntary donors and creating awareness on the general public regarding HIV, HBsAg and HCV transmission and prevention should be strengthen.

Rubella virus infections and immune status among pregnant women before the introduction of rubella vaccine in Amhara Regional State, Ethiopia.

BACKGROUND: Rubella and its associated congenital anomalies have been greatly reduced in most developed countries through use of the rubella vaccine. However, the magnitude of the problem is underestimated and there are no well-established rubella/congenital rubella syndrome prevention and control strategies in many developing countries, including Ethiopia. The aim of this study was to determine the prevalence of rubella virus infections among pregnant women and their immune status before the introduction of rubella vaccine in Amhara Regional State, Ethiopia. METHODS: A prospective cross-sectional study was conducted among pregnant women in Dessie, Felege-Hiwot, and University of Gondar referral hospitals, from December 2015 to February 2017. After obtaining written informed consent, socio-demographic data, reproductive history, clinical manifestations, and the possible risk factors for rubella virus infections were collected using a structured questionnaire. The laboratory analysis of rubella-specific antibodies was done using an enzyme-linked immunoassay method on venous blood samples. Data were entered and analyzed using IBM SPSS Statistics version 20. Binary logistic regression was used to determine the strength of association between the dependent variables and covariates. RESULTS: A total of 600 pregnant women were included in the study. Their mean age was 26.4±5years (range 16-40 years). The overall seroprevalence of rubella infection was 89%. Of the total study participants, 9.5% were positive for rubella-specific IgM antibody, which indicates acute/recent rubella virus infection. In contrast, 79.5% of them had protective levels of rubella-specific IgG antibody and were immune as a result of previous wild-type rubella infection. However, 11% of the pregnant women were negative for both rubella-specific antibodies; these women represent the susceptible group. CONCLUSIONS: A large number of pregnant women had acute/recent rubella virus infections at the time of data collection, indicating that the virus is endemic in the study area. More than a tenth of pregnant women were found to be susceptible to acquiring the infection in future pregnancies, with the possible risk of rubella-associated congenital anomalies. Hence screening of all women of child-bearing age before conception and during pregnancy might reduce the devastating effects of the virus on the developing fetus.

Anemia and thrombocytopenia in the cohort of HIV-infected adults in northwest Ethiopia: a facility-based cross-sectional study.

BACKGROUND: Anemia and thrombocytopenia are frequent hematological abnormalities in patients with human immunodeficiency virus (HIV) infection and have been associated with increased morbidity and mortality. However, there is a paucity of data on the prevalence and correlates of these hematological abnormalities among HIV infected adults in Ethiopia. The aim of this study was to determine the prevalence and correlates of anemia and thrombocytopenia in a cohort of HIV-1 infected adults in northwest Ethiopia. METHODS: A total of 320 HIV-infected adults were enrolled into the study, from March 2016 to July 2016. Sociodemographic and clinical characteristics of the study participants were recorded. Blood samples were collected from each patient to determine hematological and immunological parameters. A binary logistic regression model was fitted to identify factors associated with each hematological abnormality. The odds ratio with a 95% confidence interval was calculated. A p-value <0.05 was considered statistically significant. RESULTS: Out of 320 HIV-1 positive participants, 203 (63.4%) were female. Overall, anemia was found in 25% (95% CI: 20.23 - 29.8%) of the study participants, of whom 2.5% (n=2) had severe and 21.2% (n=17) had moderate anemia. About 83.8% (67/80) anemic patients were on highly active antiretroviral therapy (HAART) for a minimum of six months, and 31 of them were receiving Zidovudine (AZT)-based HAART regimen. Multivariable logistic regression analysis showed that being HAART-naïve (AOR= 5.5, 95% CI: 1.5-19.9) and having CD4 count below 200 cells/µl (AOR= 2.4, 95% CI: 1.3-4.9) were independent and significant predictors of anemia. Thrombocytopenia was noted in 6.3% (95% CI: 3.58-8.9%) of the study participants. Sixty percent of thrombocytopenic (n=12) subjects were over the age of 40 years. CONCLUSION: We found an overall high prevalence of anemia in the cohort of HIV-infected adults in northwest Ethiopia. HAART naïve subjects and those with CD4 count less than 200 cells/µl were found to be at higher risk for developing anemia. This data has an important implication for management of hematological abnormalities in HIV patients and highlights the need for early initiation of HAART to reduce the burden of anemia.

Magnitude of Anemia in Geriatric Population Visiting Outpatient Department at the University of Gondar Referral Hospital, Northwest Ethiopia: Implication for Community-Based Screening.

OBJECTIVE: This study is aimed at assessing the magnitude and its associated factors of anemia in geriatric population visiting outpatient department at the University of Gondar referral hospital, northwest Ethiopia. METHOD: A cross-sectional study was conducted among elder patients in Gondar town, North Gondar District, in May 2013. A total of 200 randomly selected geriatric population participated in the study. Summary statistics were computed and presented in tables and figure. Both bivariate and multivariable binary logistic regression were fitted to identify associated factors. A P value < 0.05 was considered as statistically significant. RESULT: The median age of the study participants was 65 years (Interquartile range (IQR): 8 years). The prevalence of anemia in the geriatric patients was 54.5% (n = 109), of which 61.5% (n = 67) were males. Mild type anemia was predominant, 55.96% (n = 61). Geriatric patients with an elevated erythrocyte sedimentation rate (AOR = 9.04, 95% CI: 4.2-19.7) and who are vegetarians (AOR = 2.2, 95% CI: 1.03-4.71) were at high risk of developing anemia. CONCLUSION: The magnitude of anemia was high in geriatrics. Mild anemia was the predominant type. Vegetarians and geriatrics with elevated erythrocyte sedimentation rate were more likely to develop anemia. Hence, early diagnosis and management of anemia have paramount importance to prevent adverse outcomes in geriatrics.

Agreement between Direct Fluorescent Microscopy and Ziehl-Neelsen Concentration Techniques in Detection of Pulmonary Tuberculosis in Northwest Ethiopia.

BACKGROUND: The sensitivity of smear microscopy for diagnosis of tuberculosis might be improved through treatment of sputum with sodium hypochlorite and application of fluorescent microscopy. This study aimed to determine the agreement between direct Fluorescent Microscopy and Ziehl-Neelsen concentration technique by their ability of detecting acid fast bacilli in resource poor settings. METHODS: A cross sectional study was conducted at Gondar University Referral Hospital, Northwest Ethiopia. Three sputum specimens were collected from consecutive TB suspects. Direct and concentrated sputum smears were air-dried, heat-fixed and stained by auramine O and Ziehl-Neelsen staining techniques respectively. The stained slides were examined for acid fast bacilli using direct Fluorescent Microscopy and Ziehl-Neelsen concentration techniques. RESULTS: Of 293 specimens, 4.4% and 2.4 % were AFB positive by direct fluorescent microscopy and Ziehl-Neelsen bleach concentrated techniques respectively. There was high percentage of tuberculosis positivity from early morning sputum samples (2.4%) compared to first spot (1.4%) and second spot (1.7%) sputum samples when using Ziehl-Neelsen sodium hypochlorite concentration technique. A moderate agreement was seen between the two methods (Kappa=0.484, P value<0.001). CONCLUSION: Direct fluorescent microscopy has shown high positivity rate compared to Ziehl-Neelsen concentration technique. A moderate agreement was seen between the two methods. Thus, Ziehl-Neelsen bleach sedimentation technique is recommended for detection of pulmonary tuberculosis at peripheral health service level when Fluorescent Microscopy is not available.

Vitamin D deficiency among newly diagnosed tuberculosis patients and their household contacts: a comparative cross-sectional study.

BACKGROUND: Recent studies suggest that the incidence and severity of tuberculosis is associated with low levels of vitamin D. Even though individuals living in Ethiopia have a high exposure to sunlight which is a source of vitamin D, tuberculosis is still one of the major causes of morbidity and mortality in the country. Therefore, this study aimed to determine the prevalence and associated factors of vitamin D deficiency in newly diagnosed tuberculosis patients, household contacts and community controls in Gondar, Ethiopia. METHODS: A comparative cross-sectional study design was conducted. Blood samples were collected from newly diagnosed smear positive pulmonary TB patients, their household contacts and community controls. Serum 25(OH)-vitamin D3 was determined by an Enzyme Linked Immunosorbent Assay. A serum level of 25(OH)-vitamin D3 below < 50 nmol/L was defined as vitamin D deficiency and <25 nmol/L as severe vitamin D deficiency. RESULTS: A total of 126 newly diagnosed smear positive TB patients, 57 house hold contacts and 70 apparently community controls were included in the study. The mean ± SD age (years) of TB patients, house hold contacts and community controls was 29.8 ± 11.9, 24.3 ± 14.7 and 27.3 ± 7.6 respectively. Ninety out of 126 (71.4%) TB patients were underweight with a BMI of < 18.5 kg/m2. The mean 25(OH)-vitamin D3 level of TB patients (30.1 ± 19.3 nmol/L) was significantly lower than community controls (38.5 ± 20.9 nmol/L, P = 0.005 and household contacts (37.7 ± 12.8 nmol/L, P =0.031).). The prevalence of vitamin D deficiency was higher in TB patients (83.3%) than in community controls (67.1%, P = 0.009). The prevalence of vitamin D deficiency was also found higher in household contacts (80.7%). Severe vitamin D deficiency was observed in 53%(67/126), 30% (21/70), 19.3%(11/57) of TB patients, community controls and household contacts respectively. Low BMI (AOR = 2.13; 95%CI: 1.02, 3.28) and being positive for tuberculosis (AOR = 1.93; 95%CI: 1.06, 2.86) were significant predictors of severe vitamin D deficiency. CONCLUSION: High prevalence of vitamin D deficiency was found among newly diagnosed TB patients and in their household contacts. The present study warrants further studies to determine the role of vitamin D supplementation in the prevention and treatment of tuberculosis in Ethiopia.

Immunological and hematological reference intervals among HIV-seronegative pregnant women in northwest Ethiopia.

BACKGROUND: Pregnancy is a state characterized by profound physiological hematological changes. However, hematological reference intervals being used in clinical practice in Ethiopia are derived from nonlocal general populations, despite the significant variations reported previously. The aim of this study was to determine the immunological and hematological reference intervals in healthy pregnancy among HIV-seronegative pregnant women in northwest Ethiopia. MATERIALS AND METHODS: A total of 200 healthy, HIV-seronegative pregnant women were enrolled from February 2015 to June 2015 in a cross-sectional study setting at Gondar University Hospital. Sociodemographic and obstetric data were collected using a structured questionnaire. Blood samples collected from each participant were used to define the immunological and hematological parameters. The mean, median, and 95% interval values were calculated for the immunological and hematological parameters. P-value <0.05 was considered statistically significant for all variables. RESULTS: This study found that there were changes in CD4+ T-cell count, platelet count, and hematocrit (HCT) values as pregnancy advances. The calculated combined reference intervals for the absolute CD4+ T-cell count and platelet count were 712.47-760.67 and 221.25-240.14, respectively. A progressive decline in the platelet count was observed as pregnancy advanced, with 95% intervals of 224.53-253.21, 209.50-237.38, and 213.70-247.86 in the first, second, and third trimesters, respectively (P=0.27). There was a statistically significant increase in mean (±standard deviation [SD]) HCT with gestational age, being 39.18±6.70, 41.96±3.70, and 40.53±3.77 in the first, second, and third trimesters, respectively (P=0.03). The overall 95% interval for hemoglobin (HB) concentration was 12.99-13.36 g/dL, HCT 40.19%-41.49%, mean corpuscular volume (MCV) 93.33-94.63 fL, and mean corpuscular hemoglobin (MCH) 28.88-34.81 pg. Compared with the reference ranges derived from other studies, we found considerable variations in CD4+T-cell count, HB, HCT, and MCV values. CONCLUSION: The findings of this study highlight the differences in immunohematological profile among pregnant women and nonpregnant women from Ethiopia and other countries, in addition to suggesting the need for such establishment of local reference values for different populations.

Seroprevalence of human immunodeficiency virus among voluntary counseling and testing clients at the University of Gondar Teaching Hospital, Northwest Ethiopia.

BACKGROUND: The epidemiology of human immunodeficiency virus (HIV) infection in Ethiopia varies with regions, study population, and time. Thus, timely information on HIV epidemiology is critical for the combat of the epidemic. In this study, we aim to update HIV prevalence and risk factors among voluntary counseling and testing (VCT) clients at the University of Gondar Teaching Hospital, Northwest Ethiopia. METHODS: A total of 2,120 VCT clients' records from September 2007 to August 2010 were analyzed retrospectively. Bivariate logistic regression analysis was used to identify significant predictors. Odds ratio (OR) and 95% confidence intervals (CIs) were calculated. Statistical significance was set at P-value <0.05. RESULTS: Of 2,120 VCT clients, 363 (17.1%) were seropositive for HIV. A higher rate of HIV positivity was observed among female clients (20.4%) than that in male clients (14.0%) (OR 1.58, 95% CI 1.26-1.98, P=0.00). Widowed (95% CI 10.42-34.92, P=0.00), married (95% CI 3.42-5.94, P=0.00), divorced (95% CI 2.79-5.32, P=0.00), and illiterate (95% CI 2.33-5.47, P=0.00) clients were associated with HIV infection with the odds ratios of 19.07, 4.51, 3.85, and 3.57, respectively. Clients within the age category of 35-49 years (OR 5.03, 95% CI 3.56-7.12, P=0.00) and above the age of 50 years (OR 4.99, 95% CI 2.67-9.34, P=0.00) were more likely to be infected with HIV. CONCLUSION: HIV is still the major concern of public health in the Gondar area as evidenced by our data. Being female, widowed, married, illiterate, and older age were the identified risk factors for HIV infection. Thus, consideration of these factors in future intervention and clinical practice is recommended.

A 5-year trend of Helicobacter pylori seroprevalence among dyspeptic patients at Bahir Dar Felege Hiwot Referral Hospital, Northwest Ethiopia.

BACKGROUND: Helicobacter pylori infection is a major public health problem affecting half of the world's population. The prevalence of H. pylori varies in different societies and geographical locations. Thus, timely information on H. pylori epidemiology is critical to combat this infection. This study aimed to determine the seroprevalence and trend of H. pylori infection over a period of 5 years among dyspeptic patients at Bahir Dar Felege Hiwot Referral Hospital, Northwest Ethiopia. METHODS: A retrospective analysis of consecutive dyspeptic patients' records covering the period between January 2009 and December 2013 was conducted. The hospital laboratory generated the data by a serological method of detecting the antibodies for H. pylori from serum by a one-step rapid test device. Chi-square analysis was used to identify significant predictors. A P-value of <0.05 was considered as statistically significant. RESULTS: Among all the study subjects, 2,733 (41.6%) were found to be seropositive. The seroprevalence was significantly higher in males (43.2%) than in females (39.9%) (χ2=9; P=0.002). In terms of age groups of the patients, high rates of H. pylori were found among the participants older than 60 years (57%) (χ2=36.6; P≤0.00001). The trend analysis of H. pylori prevalence revealed a fluctuating prevalence; it was 44.5% in the year 2009 and decreased to 34% and 40% in the years 2010 and 2011, respectively. However, there was an increment to 52.5% in the year 2012, and then it decreased to 30.2% in the year 2013. CONCLUSION: This study showed high seroprevalence of H. pylori among the dyspeptic patients in Bahir Dar Felege Hiwot Referral Hospital. The trend of the seroprevalence varied from year to year in the 5 consecutive years. Considering this, designing appropriate prevention and control strategies is mandatory.

Prevalence and clinical correlates of Schistosoma mansoni co-infection among malaria infected patients, Northwest Ethiopia.

BACKGROUND: In Ethiopia, where malaria and schistosomiasis are co-endemic, co-infections are expected to be high. However, data about the prevalence of malaria-schistosomiasis co-infection and their clinical correlation is lacking. Therefore, the aim of this study was to assess prevalence of Schistosoma mansoni co-infection and associated clinical correlates in malaria patients. METHODS: A cross-sectional study was conducted in 2013 at Chwahit Health Center, in northwest Ethiopia. Blood film positive malaria patients (N = 205) were recruited for the study. Clinical, parasitological, hematological, and biochemical parameters were assessed from every study participant. Stool samples were also collected and processed with Kato-Katz technique to diagnose and classify intensity of Schistosoma mansoni. RESULTS: The prevalence of Schistosoma mansoni and malaria co-infection was 19.5%. The age group of 16-20 years old was significantly associated with co-infection. Co-infected patients with a moderate-heavy egg burden of Schistosoma mansoni had significantly high mean Plasmodium parasitemia. On the other hand, age group of 6-10 years old and moderate-heavy Schistosoma mansoni co-infection were significantly associated with severe malaria. CONCLUSIONS: Prevalence of malaria and Schistosoma mansoni co-infection in the study area was considerably high. Severity of malaria and parasitemia of Plasmodium were associated with certain age groups and intensity of concurrent Schistosoma mansoni. Further study is needed to explore the underlying mechanisms of interaction between malaria and Schistosoma mansoni.

Prevalence of tuberculosis and treatment outcome among university students in Northwest Ethiopia: a retrospective study.

BACKGROUND: Universities tend to be highly congregate settings, both in the classroom and in residences, and thus provide special opportunities for large number of persons to be exposed to a person with tuberculosis (TB). Despite the high prevalence of TB in Ethiopia, the TB prevalence and the treatment outcome among students have never been studied. Therefore, this study was aimed at determining the prevalence and treatment outcome of TB among students at University of Gondar from January 2007 to December 2011. METHODS: Data on age, sex, TB type, category, and treatment outcome of students with TB was collected from medical records of University of Gondar Hospital, TB Directly Observed Treatment Short Course (DOTS) clinic. All TB cases diagnosed with smear, culture, and/or radiography were included in the study. RESULTS: During the five year study period in the university, there were an average of 36 students with TB per year out of a mean of 10,036 enrolled students. Smear positive pulmonary TB, smear negative pulmonary TB, and extra pulmonary TB, respectively, were observed in 46 (25.4%), 81 (44.8%) and 54 (29.8%) of the cases. The prevalence of all forms of TB per 100,000 populations in the University ranged from 297.6 in 2009 to 404 in 2011, respectively. The prevalence of TB in the Social Sciences and Humanities Faculty was higher than the one observed in the Medical College. The overall treatment outcome was classified as cured in 36 (19.9%), completed in 91 (50.3%), defaulted in 9 (5%), failed in 3 (1.7%), died in 1 (0.6%), and transferred out in 41 (22.7%) of the cases. Treatment success rate (TSR) among students in University was generally low ranging from 58.1% in 2009 to 82.9% in 2011 with a mean TSR of 70.2%. CONCLUSION: The prevalence of TB is higher in comparison to the national figure among students in University of Gondar. Active surveillance systems could be important to get a clear picture of the TB situation in such settings. Assessing the factors associated with the high prevalence to gear the TB control strategy could also be essential.

Establishment of Normal Reference Intervals for CD3(+), CD4(+), CD8(+), and CD4(+) to CD8(+) Ratio of T Lymphocytes in HIV Negative Adults from University of Gondar Hospital, North West Ethiopia.

Background. Reference values for the CD3(+), CD4(+), CD8(+), and CD4(+) to CD8(+) ratio T lymphocyte subsets are adopted from textbooks. But for appropriate diagnosis, treatment, and follow-up of patients, correct interpretations of the laboratory results from normal reference interval are mandatory. This study was, therefore, planned to establish normal reference interval for T lymphocytes subset count and CD4(+) to CD8(+) ratio. Methods. A cross-sectional study was conducted on apparently healthy adult individuals who visited voluntary counseling and HIV testing clinic Gondar University Hospital from April to May, 2013. Whole blood was analyzed using fluorescence-activated cell sorting (BD FACS, San Jose, CA) machine to enumerate the T-cell subpopulations. Results. Out of the total 320 study participants, 161 (50.3%) were men and 159 (49.7%) were women. The normal reference intervals were (655-2,823 cells/µL), (321-1,389 cells/µL), and (220-1,664 cells/µL) for CD3(+), CD4(+), and CD8(+) T lymphocyte subsets, respectively, and CD4(+) to CD8(+) ratio was 0.5-2.5. Conclusion. The overall CD3(+) T lymphocytes reference interval in the current study was wide; low CD4(+) T lymphocytes, CD4 to CD8 ratio, and high CD8(+) T lymphocytes values were observed.

Determining the severity of Plasmodium falciparum malaria in Ethiopia.

BACKGROUND: In the majority of health centers in Ethiopia, the severity of falciparum malaria has been determined by parasitemia alone. However, it has been suggested that the use of peripheral infected RBC counts as an indicator of disease severity by itself is insufficient. Therefore, this study was performed to assess the severity of falciparum malaria infection in three Ethiopian localities with epidemic malaria and to compare the usual severe malaria determination technique (parasitemia) used in Ethiopia with other malaria severity determination parameters: circulatory collapse, cerebral malaria and severe anemia. METHODS: Blood samples were collected from 400 individuals to examine the presence of falciparum malaria in the Awash, Metehara and Ziway areas of Ethiopia. Data on cerebral malaria, circulatory collapse and severe anemia were collected from 210 falciparum malaria patients. RESULTS: Of the 400 individuals examined, 210 were positive for falciparum malaria, and 190 were negative and served as healthy controls (HC). Severe anemia (18 patients, 8.57%) and circulatory collapse (25 patients, 11.90%) were the common features associated with severe falciparum malaria. Additionally, the detection of severe malaria was comparable using parasitemia, circulatory collapse or anemia. CONCLUSION: The findings of this study demonstrated comparable capacity for detecting severe falciparum malaria using circulatory collapse, severe anemia or parasitemia. Therefore, in addition to parasitemia, assessing severity of falciparum malaria using circulatory collapse and severe anemia will facilitate the diagnosis and management of malaria in Ethiopia.

Comparison of CareStart™ HRP2/pLDH COMBO rapid malaria test with light microscopy in north-west Ethiopia.

BACKGROUND: In Ethiopia, light microscopy is the gold standard for malaria diagnosis although it is not available in most peripheral health facilities. It is time consuming, requires trained personnel and needs careful preparation and application of reagents to ensure quality results. This study was aimed at testing the diagnostic performance of CareStart™ malaria rapid diagnostic test (RDT) with reference to light microscopy for the diagnosis of falciparum and vivax malaria in Ethiopia. METHODS: Blood samples were collected from 254 patients suspected to have malaria at Kola Diba Health Center in the late malaria transmission peak season from November 2011 to December 2011. The samples were examined immediately by light microscopy and the RDT (CareStart™ Malaria HRP2/pLDH COMBO Test kit). Statistical analysis was performed using SPSS version 16 and the JavaStat two-way contingency table analysis. RESULTS: The overall sensitivity and specificity of CareStartTM RDT was found to be 95% (90-97.9%, 95% CI) and 94.2% (90.9-96%, 95% CI), respectively. The sensitivity of the CareStartTM RDT for Plasmodium falciparum or mixed infection was calculated to be 92.9% (82.5-98%, 95%CI) while a sensitivity of 90.9% (74.1-98.4%, 95%CI) was found for non-falciparum species. The specificity for P. falciparum or mixed infections was found to be 95.4% (92.5-96.8%, 95%CI) while it was 97.3% (94.8-98.4%, 95%CI) for non-falciparum species. There was an excellent agreement between the two tests with a kappa value of 0.918. CONCLUSION: The CareStartTM RDT test showed good sensitivity and specificity with an excellent agreement to the reference light microscopy. The RDT could therefore be used in place of light microscopy, which in poor set-ups cannot be used routinely.