SMS photograph-based external quality assessment of reading and interpretation of malaria rapid diagnostic tests in the Democratic Republic of the Congo.

BACKGROUND: The present External Quality Assessment (EQA) assessed reading and interpretation of malaria rapid diagnostic tests (RDTs) in the Democratic Republic of the Congo (DRC). METHODS: The EQA consisted of (i) 10 high-resolution printed photographs displaying cassettes with real-life results and multiple choice questions (MCQ) addressing individual health workers (HW), and (ii) a questionnaire on RDT use addressing the laboratory of health facilities (HF). Answers were transmitted through short message services (SMS). RESULTS: The EQA comprised 2344 HW and 1028 HF covering 10/11 provinces in DRC. Overall, median HW score (sum of correct answers on 10 MCQ photographs for each HW) was 9.0 (interquartile range 7.5 - 10); MCQ scores (the % of correct answers for a particular photograph) ranged from 54.8% to 91.6%. Most common errors were (i) reading or interpreting faint or weak line intensities as negative (3.3%, 7.2%, 24.3% and 29.1% for 4 MCQ photographs), (ii) failure to distinguish the correct Plasmodium species (3.4% to 7.0%), (iii) missing invalid test results (8.4% and 23.6%) and (iv) missing negative test results (10.0% and 12.4%). HW who were trained less than 12 months ago had best MCQ scores for 7/10 photographs as well as a significantly higher proportion of 10/10 scores, but absolute differences in MCQ scores were small. HW who had participated in a previous EQA performed significantly better for 4/10 photographs compared to those who had not. Except for two photographs, MCQ scores were comparable for all levels of the HF hierarchy and non-laboratory staff (HW from health posts) had similar performance as to laboratory staff. Main findings of the questionnaire were (i) use of other RDT products than recommended by the national malaria control programme (nearly 20% of participating HF), (ii) lack of training for a third (33.6%) of HF, (iii) high proportions (two-thirds, 66.5%) of HF reporting stock-outs. CONCLUSIONS: The present EQA revealed common errors in RDT reading and interpretation by HW in DRC. Performances of non-laboratory and laboratory staff were similar and dedicated training was shown to improve HW competence although to a moderate extent. Problems in supply, distribution and training of RDTs were detected.

External quality assessment of Giemsa-stained blood film microscopy for the diagnosis of malaria and sleeping sickness in the Democratic Republic of the Congo.

OBJECTIVE: To report the findings of a second external quality assessment of Giemsa-stained blood film microscopy in the Democratic Republic of the Congo, performed one year after the first. METHODS: A panel of four slides was delivered to diagnostic laboratories in all provinces of the country. The slides contained: (i) Plasmodium falciparum gametocytes; (ii) P. falciparum trophozoites (reference density: 113,530 per µl); (iii) Trypanosoma brucei subspecies; and (iv) no parasites. FINDINGS: Of 356 laboratories contacted, 277 (77.8%) responded. Overall, 35.0% of the laboratories reported all four slides correctly but 14.1% reported correct results for 1 or 0 slides. Major errors included not diagnosing trypanosomiasis (50.4%), not recognizing P. falciparum gametocytes (17.5%) and diagnosing malaria from the slide with no parasites (19.0%). The frequency of serious errors in assessing parasite density and in reporting false-positive results was lower than in the previous external quality assessment: 17.2% and 52.3%, respectively, (P < 0.001) for parasite density and 19.0% and 33.3%, respectively, (P < 0.001) for false-positive results. Laboratories that participated in the previous quality assessment performed better than first-time participants and laboratories in provinces with a high number of sleeping sickness cases recognized trypanosomes more frequently (57.0% versus 31.2%, P < 0.001). Malaria rapid diagnostic tests were used by 44.3% of laboratories, almost double the proportion observed in the previous quality assessment. CONCLUSION: The overall quality of blood film microscopy was poor but was improved by participation in external quality assessments. The failure to recognize trypanosomes in a country where sleeping sickness is endemic is a concern.

External quality assessment of malaria microscopy in the Democratic Republic of the Congo.

BACKGROUND: External quality assessments (EQA) are an alternative to cross-checking of blood slides in the quality control of malaria microscopy. This study reports the findings of an EQA of malaria microscopy in the Democratic Republic of the Congo (DRC). METHODS: After validation, an EQA slide panel and a questionnaire were delivered to diagnostic laboratories in four provinces of DRC. The panel included three samples for diagnosis (sample 1: Plasmodium falciparum, 177,000/µl, sample 2: P. falciparum, 2,500/µl, sample 3: no parasites seen), one didactic sample (Howell-Jolly bodies) and one sample for assessing the quality of staining. Participating laboratories were addressed and selected through the network of the National Tuberculosis Control Programme. Participants were asked to return the responses together with a stained thin and thick blood film for evaluation of Giemsa stain quality. RESULTS: Among 174 participants (response rate 95.1%), 26.2% scored samples 1, 2 and 3 correctly and 34.3%, 21.5% and 5.8% of participants reported major errors in one, two or three samples respectively. Major errors included reporting "no malaria" or "non-falciparum malaria" for Plasmodium falciparum-positive samples 1 and 2 (16.1% and 34.9% of participants respectively) and "P. falciparum" for Plasmodium negative sample 3 (24.0%). Howell-Jolly bodies (didactic sample) were not recognized by any of the participants but reported as "P. falciparum" by 16.7% of participants. With parasite density expressed according to the "plus system", 16.1% and 21.5% of participants scored one "+" different from the reference score for samples 1 and 2 respectively and 9.7% and 2.9% participants scored more than two "+" different. When expressed as counts of asexual parasites/µl, more than two-thirds of results were outside the mean ± 2SD reference values. The quality of the Giemsa stain was poor, with less than 20% slides complying with all criteria assessed. Only one quarter of participants purchase Giemsa stain from suppliers of documented reliability and half of participants use a buffered staining solution. One third of participants had participated in a formal training about malaria diagnosis, half of them earlier than 2007. CONCLUSION: The present EQA revealed a poor quality of malaria microscopy in DRC.

Performance of Microscopy for the Diagnosis of Malaria and Human African Trypanosomiasis by Diagnostic Laboratories in the Democratic Republic of the Congo: Results of a Nation-Wide External Quality Assessment.

The present External Quality Assessment (EQA) assessed microscopy of blood parasites among diagnostic laboratories in the Democratic Republic of the Congo. The EQA addressed 445 participants in 10/11 provinces (October 2013-April 2014). Participants were sent a panel of five slides and asked to return a routinely stained slide which was assessed for quality of preparation and staining. Response rate was 89.9% (400/445). For slide 1 (no parasites), 30.6% participants reported malaria, mostly Plasmodium falciparum. Only 11.0% participants reported slide 2 (Plasmodium malariae) correctly, 71.0% reported "malaria" or "Plasmodium falciparum" (considered acceptable). Slide 3 contained Plasmodium falciparum (109/µl) and Trypanosoma brucei brucei trypomastigotes: they were each reported by 32.5% and 16.5% participants respectively, 6.0% reported both. Slide 4 (Trypanosoma) was recognised by 44.9% participants. Slide 5 (Plasmodium ovale) was correctly reported by 6.2% participants, another 68.8% replied "malaria" or "Plasmodium falciparum" (considered acceptable). Only 13.6% of routine slides returned were correctly prepared and stained. The proportion of correct/acceptable scores for at least 4/5 slides was higher among EQA-experienced participants compared to first time participants (40.9% versus 22.4%, p = 0.001) and higher among those being trained < 2 years ago compared to those who were not (42.9% versus 26.3%, p = 0.01). Among diagnostic laboratories in Democratic Republic of the Congo, performance of blood parasite microscopy including non-falciparum species and Trypanosoma was poor. Recent training and previous EQA participation were associated with a better performance.

Severity of outcomes associated to illnesses funded by GFATM initiative and socio demographic and economic factors associated with HIV/AIDS, TB and malaria mortality in Kinshasa Hospitals, DRC.

BACKGROUND: For the past decades, developing countries have received considerable support to fight infectious illnesses in their homelands. This global effort has tremendously reduced case fatality rates associated with illnesses such as HIV/AIDS, tuberculosis and malaria in many countries. However, this information is still missing in some developing countries, hindering international effort for control programs; we designed this study in effort to close this gap. METHODS: Data on 23,487 inpatients from Kinshasa hospitals were gathered and analyzed using EpiData and SPSS. Major illnesses affecting inpatients were identified; mortality and case fatality rates associated with each such illness were estimated. Case fatality rates associated with each illness were compared between consecutive years. Socio demographic and economic factors associated with mortality due to HIV/AIDS, TB and malaria were investigated using logistic regression. RESULTS: The outstanding findings were that case fatality rates associated with major illnesses were relatively higher in 2008 than in the previous year; inpatients hospitalized for HIV/AIDS, TB and malaria in 2008 were more likely to die than those hospitalized in the previous year. Low socioeconomic status inpatients hospitalized for malaria, HIV/AIDS or TB were more likely to die than high socioeconomic status inpatients (AOR 0.29, 95% CI 0.22-0.40; AOR 0.20, 95%CI0.12-0.33; AOR 0.33, 95%CI 0.21-0.53), even though both groups presumably had access to free life-saving treatment and care. CONCLUSION: These results indicate that while improvement in health indicators greatly depends on funds availability and sustainability, these alone might not be enough in resource poor developing countries. Other factors, i.e., population SES also need to be addressed before needed changes may occur.

False positivity of non-targeted infections in malaria rapid diagnostic tests: the case of human african trypanosomiasis.

BACKGROUND: In endemic settings, diagnosis of malaria increasingly relies on the use of rapid diagnostic tests (RDTs). False positivity of such RDTs is poorly documented, although it is especially relevant in those infections that resemble malaria, such as human African trypanosomiasis (HAT). We therefore examined specificity of malaria RDT products among patients infected with Trypanosoma brucei gambiense. METHODOLOGY/PRINCIPAL FINDINGS: Blood samples of 117 HAT patients and 117 matched non-HAT controls were prospectively collected in the Democratic Republic of the Congo. Reference malaria diagnosis was based on real-time PCR. Ten commonly used malaria RDT products were assessed including three two-band and seven three-band products, targeting HRP-2, Pf-pLDH and/or pan-pLDH antigens. Rheumatoid factor was determined in PCR negative subjects. Specificity of the 10 malaria RDT products varied between 79.5 and 100% in HAT-negative controls and between 11.3 and 98.8% in HAT patients. For seven RDT products, specificity was significantly lower in HAT patients compared to controls. False positive reactions in HAT were mainly observed for pan-pLDH test lines (specificities between 13.8 and 97.5%), but also occurred frequently for the HRP-2 test line (specificities between 67.9 and 98.8%). The Pf-pLDH test line was not affected by false-positive lines in HAT patients (specificities between 97.5 and 100%). False positivity was not associated to rheumatoid factor, detected in 7.6% of controls and 1.2% of HAT patients. CONCLUSIONS/SIGNIFICANCE: Specificity of some malaria RDT products in HAT was surprisingly low, and constitutes a risk for misdiagnosis of a fatal but treatable infection. Our results show the importance to assess RDT specificity in non-targeted infections when evaluating diagnostic tests.

External quality assessment of reading and interpretation of malaria rapid diagnostic tests among 1849 end-users in the Democratic Republic of the Congo through Short Message Service (SMS).

BACKGROUND: Although malaria rapid diagnostic tests (RDT) are simple to perform, they remain subject to errors, mainly related to the post-analytical phase. We organized the first large scale SMS based external quality assessment (EQA) on correct reading and interpretation of photographs of a three-band malaria RDT among laboratory health workers in the Democratic Republic of the Congo (DR Congo). METHODS AND FINDINGS: High resolution EQA photographs of 10 RDT results together with a questionnaire were distributed to health facilities in 9 out of 11 provinces in DR Congo. Each laboratory health worker answered the EQA by Short Message Service (SMS). Filled-in questionnaires from each health facility were sent back to Kinshasa. A total of 1849 laboratory health workers in 1014 health facilities participated. Most frequent errors in RDT reading were i) failure to recognize invalid (13.2-32.5% ) or negative test results (9.8-12.8%), (ii) overlooking faint test lines (4.1-31.2%) and (iii) incorrect identification of the malaria species (12.1-17.4%). No uniform strategy for diagnosis of malaria at the health facility was present. Stock outs of RDTs occurred frequently. Half of the health facilities had not received an RDT training. Only two thirds used the RDT recommended by the National Malaria Control Program. Performance of RDT reading was positively associated with training and the technical level of health facility. Facilities with RDT positivity rates >50% and located in Eastern DR Congo performed worse. CONCLUSIONS: Our study confirmed that errors in reading and interpretation of malaria RDTs are widespread and highlighted the problem of stock outs of RDTs. Adequate training of end-users in the application of malaria RDTs associated with regular EQAs is recommended.