The sensitivity and specificity of a urine based Rapid Diagnostic Test for the diagnosis of <i>plasmodium falciparum</i> in a malaria endemic area in Odisha, India

Samal, Ajit Gopal; Behera, Prativa Kumari; Mohanty, Akshay Kumar; Satpathi, Sanghamitra; Kumar, Abhishek; Panda, Rajendran; Minz, Aruna Mukti; Mohanty, Sanjib; Samal, Abhijit; Pluijm, Rob W van der

doi:10.1080/20477724.2017.1380945

Cited by 11 publications

(19 citation statements)

References 16 publications

(15 reference statements)

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“…A high PPV of >90% is an indication that urine has good potentials of being a specimen for malaria diagnosis. Similar findings were also reported by Buppan et al, (2010) and Samal et al, (2017). An improvement in the sensitivity of the kits may enable low levels of malaria antigen found in urine to be detected (Genton et al, 1998).…”

Section: Discussionsupporting

confidence: 81%

“…Genton et al (1998) reported 84% ® sensitivity for a blood based mRDT (ParaSight -F test) with blood and 26% with urine as specimen for malaria testing. Similar findings were also reported by Buppan et al (2010), Anchinmane and Shedge (2016) and Samal et al (2017). The lower sensitivity might be due to the degradation or proteolytic cleavage of HRP2 excreted in urine (Ehrich et al, 1985;Mharakurwa et al, 2006).…”

Section: Discussionsupporting

confidence: 80%

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Comparison of performance characteristics of two malaria rapid diagnostic tests in detecting malaria infection among febrile patients in Urban Area of Lagos, Nigeria

Odeniyi¹,

Agomo²,

Okangba³

et al. 2020

ijs

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Antigen-based malaria rapid diagnostic tests (mRDT) play an important role in confirmation of malaria cases in all levels of healthcare in Nigeria because they are fast, easy to perform, and do not require special equipment or electricity. This study aimed at assessing the performance of two mRDTs in detecting histidine-rich protein 2 antigen in blood and urine of persons with uncomplicated falciparum malaria. Malaria parasite microscopy was the malaria diagnosis gold standard in this study. Matched blood and urine samples from 1,026 febrile persons were tested with two commercially available malaria antigen-detecting kits (SD Bioline and First Response® ). Based on blood samples, similar malaria positivity rates were obtained by microscopy 181 (17.6%), SD Bioline 186 (18.1%) and First Response® 183 (17.8%). Detection of HRP2 antigens in urine was significantly lower than HRP2 detection in blood (P<0.001) regardless of brand of mRDT used [SD Bioline (5.2% vs 18.1%) and First Response® (4.6% vs 17.8%)]. The performance characteristics of SD Bioline and First Response® using blood samples were similar (P>0.05): sensitivity 96.7% vs 95.0%; specificity 98.7% vs 98.7%, Positive Predictive Value (PPV) 92.5% vs 94% and Negative Predictive Value (NPV) 99.3% vs 86.4%. SD Bioline and First Response® HRP2 in urine and blood by the two kits was not dependent on the level of parasitaemia. The performance of the two brands of mRDTs in detecting HRP2 in whole blood and urine were similar (P>0.05). The two kits serve as good alternatives to malaria microscopy. The high NPV of both kits with urine specimen indicates that urine has the potential to be used for malaria but is not currently recommended to be used on blood-based malaria test kits. Keywords: Histidine Rich Protein® 2, Malaria Rapid Diagnostic Test, Performance characteristics, Urine.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionsupporting

confidence: 80%

Comparison of performance characteristics of two malaria rapid diagnostic tests in detecting malaria infection among febrile patients in Urban Area of Lagos, Nigeria

Odeniyi¹,

Agomo²,

Okangba³

et al. 2020

ijs

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“…Although a higher sensitivity has been recorded in urine samples from India [41], detection rates and sensitivities for mRDT on saliva and urine recorded in this study were higher than previously reported across sub-Saharan Africa [28,29]. This may be due to higher antigen levels in the samples and/or their minimal degradation since all specimens were analysed almost immediately after collection [24] and not stored [42] or spun [27] to potentially reduce the antigen concentration or activity prior to analysis.…”

Section: Discussionmentioning

confidence: 95%

Comparison of conventional and non-invasive diagnostic tools for detecting Plasmodium falciparum infection in southwestern Cameroon: a cross-sectional study

et al. 2021

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Background Malaria remains a significant health challenge in sub-Saharan Africa, with early diagnosis critical to reducing its morbidity and mortality. Despite the increasing Plasmodium spp. diagnostic capabilities, access to testing is limited in some cases by the almost absolute requirement for blood from potentially infected subjects as the only sample source for all conventional methods. A rapid test on non-invasive specimen with comparable performance to microscopy for the screening or diagnosis of all participants is invaluable. This study sought to compare conventional and non-invasive diagnostic tools for detecting Plasmodium falciparum. Methods This was a cross-sectional study, carried out between March and August 2019 to evaluate and compare the diagnostic performance of a PfHRP2/pLDH-based malaria rapid diagnostic test (mRDT) on patients’ blood, saliva and urine relative to conventional light microscopy and nested PCR at outpatient clinics in the Buea and Tiko health districts of Southwestern Cameroon. The significance of differences in proportions was explored using the Pearson’s χ2 test whereas differences in group means were assessed using analyses of variance. Results A total of 359 individuals of both sexes, aged 1–92 years, were enrolled into the study. Of the 301 individuals tested by light microscopy and mRDTs on blood, saliva and urine, 84 (27.9%), 81 (26.9%), 87 (28.9%) and 107 (35.5%) respectively were positive. However, only 34.3%, 90.5%, 91.4%, 83.9% and 65.4% febrile, light microscopy and mRDT positives on blood, saliva and urine respectively had P. falciparum infection as confirmed by PCR. The sensitivity and specificity of presumptive diagnosis, light microscopy and mRDT on blood, saliva and urine were 86.9% and 19.7%, 77.8% and 96.1%, 75.8% and 96.6%, 74.5% and 93.1%, and 70.7% and 81.8%, respectively. The agreement between mRDT on saliva (k = 0.696) and microscopy (k = 0.766) compared to PCR was good. Conclusion The study highlighted the low performance of presumptive diagnosis, reinforcing the need for parasitological tests prior to antimalarial therapy. The higher PfHRP2/pLDH mRDT parasite detection rates and sensitivity in saliva compared to urine suggests that the former is a practical adjunct to or alternative worth optimising for the routine diagnosis of malaria. Graphic Abstract Flow chart for diagnosis of P. falciparum infection by light microscopy, rapid diagnostic tests and nested PCR.

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“…Previous studies attempted to evaluate the use of non-blood samples to detect malaria antigens. In India, the sensitivities of urine in two different studies were found to be 38% [ 21 ] and 86.67% [ 22 ]. Like this study, rapid diagnostic test kits intended to be used for detecting malaria antigens in blood were used.…”

Section: Discussionmentioning

confidence: 99%

Evaluating the potential of using urine and saliva specimens for malaria diagnosis in suspected patients in Ghana

Aninagyei

Abraham

Atiiga

et al. 2020

Malar J

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Background This study aimed at detecting PfHRP2 and pLDH malaria antigens in urine and salivary specimens of suspected malaria patients using RDT kits, and identifying factors influencing the detection of these antigens. Methods Malaria rapid test kit (SD Bioline RDT kit) was used to detect malaria antigens, PfHRP2 and pLDH, in blood, urine and saliva samples received from patients suspected of malaria. Subsequently, malaria parasitaemia was determined. From the same patients, body temperature readings and haemoglobin concentrations were recorded. Also, micro-haematuria and saliva occult blood were determined. Relative to blood, the sensitivities and the performance of urine and saliva as alternative samples were evaluated. Results A total of 706 suspected malaria patients provided all three specimens. Prevalence of malaria by microscopy and RDT was 44.2% and 53.9%, respectively. Compared to blood, the sensitivities of urine and saliva were 35.2% and 57.0% respectively. Haemoglobin concentration < 9.9 g/dL, body temperature > 38.7 °C and occult blood influenced the detection of malaria antigens in both urine and saliva. Furthermore, the antigens were not detected in urine and saliva when parasitaemia was < 60,000 parasites/µL and < 40,000 parasites/µL, respectively. Conclusion Saliva, with or without blood contamination, was found to be more efficient that urine samples. Therefore these non-blood specimens have the potential to be used as non-invasive samples for malaria diagnosis. However, this approach is useful in severe to moderate anaemia, hyperthermia, parasitaemia > 60,000 parasites/µL and samples contaminated with blood.

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The sensitivity and specificity of a urine based Rapid Diagnostic Test for the diagnosis of plasmodium falciparum in a malaria endemic area in Odisha, India

Abstract: Results of this study are promising. Larger studies are needed to assess whether RDTs using urine could serve as a practical, reliable method for the detection of P. falciparum in a non-invasive manner where invasive blood taking is less feasible.

Cited by 11 publications

References 16 publications

Comparison of performance characteristics of two malaria rapid diagnostic tests in detecting malaria infection among febrile patients in Urban Area of Lagos, Nigeria

Comparison of performance characteristics of two malaria rapid diagnostic tests in detecting malaria infection among febrile patients in Urban Area of Lagos, Nigeria

Comparison of conventional and non-invasive diagnostic tools for detecting Plasmodium falciparum infection in southwestern Cameroon: a cross-sectional study

Evaluating the potential of using urine and saliva specimens for malaria diagnosis in suspected patients in Ghana

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