TY - JOUR
T1 - Evaluation of the Sensitivity of a pLDH-Based and an Aldolase-Based Rapid Diagnostic Test for Diagnosis of Uncomplicated and Severe Malaria Caused by PCR-Confirmed Plasmodium knowlesi, Plasmodium falciparum, and Plasmodium vivax
AU - Barber, Bridget
AU - William, Timothy
AU - Grigg, Matthew
AU - Piera, Kim
AU - Yeo, Tsin
AU - Anstey, Nicholas
PY - 2013
Y1 - 2013
N2 - Plasmodium knowlesi can cause severe and fatal human malaria in Southeast Asia. Rapid diagnosis of all Plasmodium species is essential for initiation of effective treatment. Rapid diagnostic tests (RDTs) are sensitive for detection of uncomplicated and severe falciparum malaria but have not been systematically evaluated in knowlesi malaria. At a tertiary referral hospital in Sabah, Malaysia, we prospectively evaluated the sensitivity of two combination RDTs for the diagnosis of uncomplicated and severe malaria from all three potentially fatal Plasmodium species, using a pan-Plasmodium lactate dehydrogenase (pLDH)-P. falciparum histidine-rich protein 2 (PfHRP2) RDT (First Response) and a pan-Plasmodium aldolase-PfHRP2 RDT (ParaHIT). Among 293 hospitalized adults with PCR-confirmed Plasmodium monoinfection, the sensitivity of the pLDH component of the pLDHPfHRP2 RDT was 74% (95/129; 95% confidence interval [CI], 65 to 80%), 91% (110/121; 95% CI, 84 to 95%), and 95% (41/43; 95% CI, 85 to 99%) for PCR-confirmed P. knowlesi, P. falciparum, and P. vivax infections, respectively, and 88% (30/34; 95% CI, 73 to 95%), 90% (38/42; 95% CI, 78 to 96%), and 100% (12/12; 95% CI, 76 to 100%) among patients tested before antimalarial treatment was begun. Sensitivity in severe malaria was 95% (36/38; 95% CI, 83 to 99), 100% (13/13; 95% CI, 77 to 100), and 100% (7/7; 95% CI, 65 to 100%), respectively. The aldolase component of the aldolase-PfHRP2 RDT performed poorly in all Plasmodium species. The pLDH-based RDT was highly sensitive for the diagnosis of severe malaria from all species; however, neither the pLDH- nor aldolase-based RDT demonstrated sufficiently high overall sensitivity for P. knowlesi. More sensitive RDTs are needed in regions of P. knowlesi endemicity. � 2013, American Society for Microbiology.
AB - Plasmodium knowlesi can cause severe and fatal human malaria in Southeast Asia. Rapid diagnosis of all Plasmodium species is essential for initiation of effective treatment. Rapid diagnostic tests (RDTs) are sensitive for detection of uncomplicated and severe falciparum malaria but have not been systematically evaluated in knowlesi malaria. At a tertiary referral hospital in Sabah, Malaysia, we prospectively evaluated the sensitivity of two combination RDTs for the diagnosis of uncomplicated and severe malaria from all three potentially fatal Plasmodium species, using a pan-Plasmodium lactate dehydrogenase (pLDH)-P. falciparum histidine-rich protein 2 (PfHRP2) RDT (First Response) and a pan-Plasmodium aldolase-PfHRP2 RDT (ParaHIT). Among 293 hospitalized adults with PCR-confirmed Plasmodium monoinfection, the sensitivity of the pLDH component of the pLDHPfHRP2 RDT was 74% (95/129; 95% confidence interval [CI], 65 to 80%), 91% (110/121; 95% CI, 84 to 95%), and 95% (41/43; 95% CI, 85 to 99%) for PCR-confirmed P. knowlesi, P. falciparum, and P. vivax infections, respectively, and 88% (30/34; 95% CI, 73 to 95%), 90% (38/42; 95% CI, 78 to 96%), and 100% (12/12; 95% CI, 76 to 100%) among patients tested before antimalarial treatment was begun. Sensitivity in severe malaria was 95% (36/38; 95% CI, 83 to 99), 100% (13/13; 95% CI, 77 to 100), and 100% (7/7; 95% CI, 65 to 100%), respectively. The aldolase component of the aldolase-PfHRP2 RDT performed poorly in all Plasmodium species. The pLDH-based RDT was highly sensitive for the diagnosis of severe malaria from all species; however, neither the pLDH- nor aldolase-based RDT demonstrated sufficiently high overall sensitivity for P. knowlesi. More sensitive RDTs are needed in regions of P. knowlesi endemicity. � 2013, American Society for Microbiology.
KW - antimalarial agent
KW - fructose bisphosphate aldolase
KW - histidine
KW - histidine rich protein 2
KW - lactate dehydrogenase
KW - protozoal protein
KW - unclassified drug
KW - adolescent
KW - adult
KW - article
KW - controlled study
KW - diagnostic test
KW - disease classification
KW - disease severity
KW - endemic disease
KW - female
KW - human
KW - major clinical study
KW - malaria falciparum
KW - male
KW - outcome assessment
KW - Plasmodium falciparum
KW - Plasmodium knowlesi
KW - Plasmodium knowlesi malaria
KW - Plasmodium vivax
KW - Plasmodium vivax malaria
KW - polymerase chain reaction
KW - priority journal
KW - prospective study
KW - rapid diagnostic test
KW - sensitivity analysis
KW - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antigens, Protozoan
KW - Diagnostic Tests, Routine
KW - Female
KW - Fructose-Bisphosphate Aldolase
KW - Humans
KW - L-Lactate Dehydrogenase
KW - Malaria
KW - Malaysia
KW - Male
KW - Middle Aged
KW - Parasitology
KW - Protozoan Proteins
KW - Sensitivity and Specificity
KW - Tertiary Care Centers
KW - Young Adult
UR - http://www.scopus.com/inward/record.url?scp=84875873760&partnerID=8YFLogxK
U2 - 10.1128/JCM.03285-12
DO - 10.1128/JCM.03285-12
M3 - Article
C2 - PubMed:23345297
SN - 0095-1137
VL - 51
SP - 1118
EP - 1123
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
IS - 4
ER -