title: SD Bioline malaria antigen Pf (HRP-2/pLHD) for assessing efficacy of artemisinin combination therapy against Plasmodium falciparum in pediatric patients in the Democratic Republic of the Congo.
abstract: BACKGROUND
  The emergence of Plasmodium falciparum resistance to artemisinin combination therapy (ACT) is a worrying development. It calls for close surveillance to monitor the efficacy of the drugs. The objectives of this study were to determine the performance of SD Bioline malaria AgPf(HRP-2/pLDH) 3 band Rapid Diagnostic Test (RDT) against Giemsa-stained blood smear and evaluate the suitability of this test in assessing the therapeutic efficacy of ACT in pediatric malaria patients in the Democratic Republic of the Congo (DRC).
  
  
  METHODS
  Five hundred and one patients with malaria symptoms were screened for P. falciparum in Kinshasa, DRC. Of the 166 patients who tested positive for P. falciparum at recruitment (day 0), 103 consented to participate in this study and were followed up and retested for P. falciparum on day 3, day 7, day 14, day 21 and day 28.
  
  
  RESULTS
  Sensitivity and specificity of the test were significantly high on day 0 and so were their positive and negative predictive values. Higher proportions of false positive cases were observed on the HRP-2 band irrespective of patient parasite densities during the follow up but these were barely seen on the pLDH band. Some patients turned positive during follow up but pLDH readings remained consistent with blood smear readings.
  
  
  CONCLUSIONS
  SD Bioline malaria AgPf(HRP-2/pLDH) RDT demonstrated high performance in DRC. Thus, the test can be employed to assess the efficacy of ACT in pediatric malaria patients and prioritize areas that require the deployment of advanced testing like polymerase chain reaction (PCR).
authors.affiliation: National Biomedical Research Institute (INRB), Democracy Avenue, P. O. Box 1197, Gombe, Kinshasa, the Democratic Republic of the Congo.
authors.forename: Albert Lukuka
authors.initials: AL
authors.lastname: Kilauzi
authors.affiliation: Department of Public Health Medicine, Faculty of Medicine, University of Botswana, Private bag 00713, Gaborone, Botswana.
authors.forename: Jose Gaby Tshikuka
authors.initials: JG
authors.lastname: Mulumba
authors.affiliation: Department of Public Health Medicine, Faculty of Medicine, University of Botswana, Private bag 00713, Gaborone, Botswana.
authors.forename: Mgaywa Gilbert Mjungu Damas
authors.initials: MG
authors.lastname: Magafu
authors.affiliation: School of Public Health, Faculty of Health Sciences, University of Botswana, Private Bag 0022, Gaborone, Botswana.
authors.forename: Reginald
authors.initials: R
authors.lastname: Matchaba-Hove
authors.affiliation: School of Public Health, Faculty of Health Sciences, University of Botswana, Private Bag 0022, Gaborone, Botswana.
authors.forename: Roy
authors.initials: R
authors.lastname: Tapera
authors.affiliation: Japan Overseas Christian Medical Co-operative Services, C/o Roman Catholic Archdiocese of Tabora, Private Bag, Tabora, Tanzania.
authors.forename: Naoko Shimizu
authors.initials: NS
authors.lastname: Magafu
authors.affiliation: National Biomedical Research Institute (INRB), Democracy Avenue, P. O. Box 1197, Gombe, Kinshasa, the Democratic Republic of the Congo.
authors.forename: Jean Jacques Muyembe
authors.initials: JJ
authors.lastname: Tamfum
mesh_terms: D000953:Antigens, Protozoan / Q000032:analysis*; D000962:Antimalarials / Q000008:administration & dosage / Q000627:therapeutic use*; D037621:Artemisinins / Q000008:administration & dosage / Q000627:therapeutic use*; D002675:Child, Preschool; D015023:Democratic Republic of the Congo; D003955:Diagnostic Tests, Routine / Q000379:methods; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000188:drug therapy / Q000276:immunology; D008297:Male; D010963:Plasmodium falciparum / Q000187:drug effects / Q000276:immunology / Q000302:isolation & purification; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D000953:Antigens, Protozoan; D000962:Antimalarials; D037621:Artemisinins; C031327:artemisinin
keywords: AgPf(HRP-2/pLDH) RDT; Democratic Republic of the Congo; Malaria; artemisinin combination therapy