Diagnostic Performance between Histidine-Rich Protein 2 (HRP-2), a Rapid Malaria Diagnostic Test and Microscopic-Based Staining Techniques for Diagnosis of Malaria

Abstract

Malaria presents a diagnostic challenge in most tropical countries such as Rwanda. Microscopy remains the gold standard for diagnosing malaria, but it is labor intensive and depends upon the skill of the examiner. Malaria rapid diagnostic tests (RDTs) have been developed as an easy, convenient alternative to microscopy. is cross-sectional study was conducted at Rukara Health Center which is located in Eastern Province, Kayonza district, Rwanda. One hundred and fifty suspected cases of malaria, who attended Rukara Health Centre, during the period, from 21 st June to 30th July 2018, were included in this study. HRP-2 RDTs (CareStart ™ Malaria HRP-2 (Access Bio, Inc., Somerset, New Jersey, USA)), for malaria were performed. ick smears were prepared and Giemsa-stained as recommended; then slides were observed under microscopy and reported quantitatively; RDTs were reported qualitatively (positive or negative). Both RDTs and thick smear results were recorded on data collection sheet. is study included a total of 150 study participants, 87 (58%) females and 63 (42%) males. e patients included in the study did not receive any antimalarial drug. e mean age of the study participants was 31.6 ± 12.4 with the majority of participants being between 25 and 44 years and the minority being above 65 years. e sensitivity of RDT (HRP-2) was calculated and found to be 95.0%, whereas the sensitivity of Giemsa microscopy was 100%. e specificity of RDT (HRP-2) was calculated and found to be 59.2%, whereas the specificity of Giemsa microscopy was 100%. Negative and positive predictive values of RDT are 85.4% and 82.7%, respectively. Negative and positive predictive values of Giemsa microscopy were both 100%. According to the results of the current study, the sensitivity, specificity, and both positive and negative predictive values of Giemsa microscopy are higher than those of histidine-rich protein 2-based rapid diagnostic test for malaria. e results obtained in histidine-rich protein 2-based rapid diagnostic test for malaria parasites should be confirmed with tests with high specificity. Further studies should determine the most appropriate type of rapid diagnostic test of malaria diagnosis to be used in combination with Giemsa microscopy. In addition, sensitivity and specificity of RDT (HRP-2) and Giemsa microscopy should be assessed against molecular biology techniques.

Summary of discordant results between rapid diagnosis tests, microscopy, and polymerase chain reaction for detecting Plasmodium mixed infection: a systematic review and meta-analysis

“…RDTs targeting HRP2 are specific for the detection of P. falciparum , while RDTs targeting LDH can be used for the detection of P. falciparum , P. vivax , or pan-specific (e.g., four Plasmodium species) LDH antibodies; aldolase is another common target for RDTs to detect all Plasmodium species 7 – 10 . Recently used commercial dipsticks for the detection of HRP-2 include PfHRP2 CareStart 11 – 13 , SD Bioline Malaria Ag Pf 14 , 15 , and SD BIOLINE Malaria Ag P.f/Pan 16 , and one recently used for the detection of pLDH is CareStart pLDH(pan) 15 . A recently used commercial dipstick for the detection of Pan-aldolase is ParaHit Total, while a recently used commercial dipsticks for the detection of P. vivax aldolase is mAb 1C3-12 F10 17 .…”

Quality Assurance (QA) Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A cross-sectional prospective study.

“…Indeed, in this study mRDT sensitivity >95% was found to be associated with malaria parasites density equal or greater than 100/ μl, a nding that is in agreement with what was found by Biso et al and Nwajei et al(30) (11). This limitation of the current mRDTs led to the development of newer generation of highly-sensitive mRDTs aimed at increasing the capability of mRDTs to detectThe speci city of 98.78% identi ed in this present study was higher than other speci city found in other studies by Niyibizi et al, Anthony et al, Henry et al and Isa et al of 59.2%, 89%, 97% and 89.6% respectively(24) (11)(15)…”

“…In 2018, a research was carried in kayonza district (Eastern province of Rwanda) and compared the performance of HRP-2 based mRDT and microscopy-based malaria test. This study found that the sensitivity of mRDT was 95.0% while speci city was found to be 59.2% among 264 suspected patients (24) and despite the extensive training of CHWs, the observed value for the speci city was below the acceptable levels. Moreover, little is known about the accuracy and predictive value of mRDT in the diagnosis of malaria infection at community level where asymptomatic people are more likely to have lower parasitaemia than in clinical settings (Vivi Maketa et al 2013) [1].…”

Quality Assurance Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A Cross-sectional Prospective Study

“…In 2018, research was carried out in Kayonza District (Eastern Province of Rwanda), and the performance of HRP-2-based mRDT and microscopy-based malaria tests were compared. This study found that the sensitivity of mRDT was 95.0%, while the specificity was 59.2% among 264 suspected patients [24], and despite the extensive training of CHWs, the observed value for the specificity was below the acceptable levels. Moreover, little is known about the accuracy and predictive value of mRDT in the diagnosis of malaria infection at the community level, where asymptomatic people are more likely to have lower parasitaemia than in clinical settings [25].…”