Sensitivity and specificity of the circulating cathodic antigen rapid urine test in the diagnosis of Schistosomiasis mansoni infection and evaluation of morbidity in a low- endemic area in Brazil

Ferreira, Fernanda Teixeira; Fidelis, Thiago Andre Alves; Pereira, Thiago A.; Otoni, Alba; Queiroz, Leonardo Campos de; Amâncio, Frederico Figueiredo; Antunes, Carlos; Lambertucci, José Roberto

doi:10.1590/0037-8682-0423-2016

Cited by 32 publications

(31 citation statements)

References 33 publications

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“…Our work adds to a growing body of literature using LCA to assess the performance of CCA [ 20 , 30 – 35 ]. Our estimates of sensitivity for both CCA and Kato-Katz were on the lower end of those observed in these other studies, and our specificity estimates for CCA were relatively high.…”

Section: Discussionmentioning

confidence: 99%

Interpreting ambiguous ‘trace’ results in Schistosoma mansoni CCA Tests: Estimating sensitivity and specificity of ambiguous results with no gold standard

et al. 2017

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BackgroundThe development of new diagnostics is an important tool in the fight against disease. Latent Class Analysis (LCA) is used to estimate the sensitivity and specificity of tests in the absence of a gold standard. The main field diagnostic for Schistosoma mansoni infection, Kato-Katz (KK), is not very sensitive at low infection intensities. A point-of-care circulating cathodic antigen (CCA) test has been shown to be more sensitive than KK. However, CCA can return an ambiguous ‘trace’ result between ‘positive’ and ‘negative’, and much debate has focused on interpretation of traces results.Methodology/Principle findingsWe show how LCA can be extended to include ambiguous trace results and analyse S. mansoni studies from both Côte d’Ivoire (CdI) and Uganda. We compare the diagnostic performance of KK and CCA and the observed results by each test to the estimated infection prevalence in the population.Prevalence by KK was higher in CdI (13.4%) than in Uganda (6.1%), but prevalence by CCA was similar between countries, both when trace was assumed to be negative (CCAtn: 11.7% in CdI and 9.7% in Uganda) and positive (CCAtp: 20.1% in CdI and 22.5% in Uganda). The estimated sensitivity of CCA was more consistent between countries than the estimated sensitivity of KK, and estimated infection prevalence did not significantly differ between CdI (20.5%) and Uganda (19.1%). The prevalence by CCA with trace as positive did not differ significantly from estimates of infection prevalence in either country, whereas both KK and CCA with trace as negative significantly underestimated infection prevalence in both countries.ConclusionsIncorporation of ambiguous results into an LCA enables the effect of different treatment thresholds to be directly assessed and is applicable in many fields. Our results showed that CCA with trace as positive most accurately estimated infection prevalence.

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Section: Discussionmentioning

confidence: 99%

Interpreting ambiguous ‘trace’ results in Schistosoma mansoni CCA Tests: Estimating sensitivity and specificity of ambiguous results with no gold standard

et al. 2017

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“…The sensitivity of POC-CCA® was 86.6% and 73.5%, and specificity was 84.6% and 93.5%, when compared to K-K (two slides) and the reference method, respectively. The study by Ferreira et al 48 demonstrated that the POC-CCA® sensitivity values were 64.3%, 61.1%, 58.3%, and 55.5%, and specificity values were 74.5%, 74.8%, 75%, and 75.6% when compared to those of one, two, four, and six K-K slides, respectively. The use of two K-K slides as a reference method overestimates the sensitivity of the POC-CCA® due to the low efficiency of K-K in detecting true positive individuals with low levels of infection.…”

Section: Performance Of Circulating Antigen-based Rdt Diagnosis In Lomentioning

confidence: 97%

“…Applying LCA enables straightforward assessment of the prevalence estimates from each test by comparing the distributions of estimated test and estimated infection prevalence. 48 , 93 The introduction of statistical LCA is encouraged, as it yields more accurate sensitivities and specificities of new tests than those obtained by comparisons to an imperfect gold standard. 93 …”

Section: Antibody Detection Is a Valuable Tool To Identify Egg-negatimentioning

confidence: 99%

“…There are 10 published studies that were conducted in Brazil. 25 , 26 , 33 , 36 , 39 , 47 , 48 , 49 , 50 , 51 The decision to adopt POC-CCA® for use in low-endemic areas of Brazil remains questionable for a number of reasons. Specifically, inadequate estimation of sensitivity and specificity of the POC-CCA® exists because of the absence of a highly sensitive reference method to evaluate its performance, interpretation of trace as either a positive or a negative reading can occur, and this test possesses low sensitivity for the detection of low-intensity infections.…”

Section: Performance Of Circulating Antigen-based Rdt Diagnosis In Lomentioning

confidence: 99%

“… 46 Only 10 studies were conducted in Brazil, which has a significantly different prevalence and morbidity profile, and these tests yielded controversial results regarding sensitivity and specificity. 25 , 26 , 33 , 36 , 39 , 47 , 48 , 49 , 50 , 51 …”

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Diagnosis of Schistosoma mansoni infections: what are the choices in Brazilian low-endemic areas?

Silva-Moraes

Shollenberger

Siqueira

et al. 2019

Mem. Inst. Oswaldo Cruz

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The population of Brazil is currently characterised by many individuals harbouring low-intensity Schistosoma mansoni infections. The Kato-Katz technique is the diagnostic method recommended by the World Health Organization (WHO) to assess these infections, but this method is not sensitive enough in the context of low egg excretion. In this regard, potential alternatives are being employed to overcome the limits of the Kato-Katz technique. In the present review, we evaluated the performance of parasitological and immunological approaches adopted in Brazilian areas. Currently, the diagnostic choices involve a combination of strategies, including the utilisation of antibody methods to screen individuals and then subsequent confirmation of positive cases by intensive parasitological investigations.

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Home-Made Lateral Flow Test Strip Versus POC-CCA Assay for Detection of Active Schistosomiasis in Egypt

Kamel,

Salah,

Demerdash

et al. 2024

Acta Parasit.

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Background For years, the Kato-Katz (KK) technique has been considered the gold standard for diagnosing schistosomiasis. The aim of this study was to compare the effectiveness of our previously developed gold nanoparticle-based lateral flow test strip (AuNPs-LFTS) for diagnosing active Schistosoma mansoni with that of the commercially available point-of-care Circulating Cathodic Antigen detection (POC-CCA) kit. Methods In this study, we collected sixty positive and twenty negative urine samples from patients in endemic hot spots in the Nile Delta, as well as from patients visiting the internal medicine clinic at Theodor Bilharz Research Institute (TBRI). We produced monoclonal antibodies (MAbs) against S. mansoni soluble egg antigen (SEA) from cloned hybridoma cells (4D/1D). These MAbs were conjugated with gold and mesoporous silica nanoparticles, and used to develop the LFTS. Results The LFTS demonstrated a limit of detection (LoD) of 3 ng/ml. The sensitivity and specificity of the developed LFTS were found to be 96.7% and 95%, respectively, compared to 85% and 90% for the POC-CCA detection kit. The cases were divided into groups based on egg count in the stool, categorized as light, moderate, and heavy infections. The sensitivity of the LFTS in the group with light infection was higher than that of the POC-CCA. When using the KK technique (eggs per gram of stool sample [EPG]) as the reference test, the kappa value for the nano-based strips was 0.902, compared to 0.672 for the CCA strips, indicating an almost perfect agreement between KK and our developed LFTS. Conclusion These results confirm the reliability and effectiveness of the LFTS compared to commercially available kits for rapid, sensitive, and early diagnosis of schistosomiasis. However, it is recommended to conduct further assessments of the developed strip on a larger scale with a broader range of cases before considering its introduction to local or international markets. Graphical Abstract

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Sensitivity and specificity of the circulating cathodic antigen rapid urine test in the diagnosis of Schistosomiasis mansoni infection and evaluation of morbidity in a low- endemic area in Brazil

Abstract: Overall, the POC-CCA urine assay proved to be a useful test for diagnosing S. mansoni in a low-endemic area in Brazil. Severe clinical forms of schistosomiasis can be present even in such low-endemic areas.

Cited by 32 publications

References 33 publications

Interpreting ambiguous ‘trace’ results in Schistosoma mansoni CCA Tests: Estimating sensitivity and specificity of ambiguous results with no gold standard

Interpreting ambiguous ‘trace’ results in Schistosoma mansoni CCA Tests: Estimating sensitivity and specificity of ambiguous results with no gold standard

Diagnosis of Schistosoma mansoni infections: what are the choices in Brazilian low-endemic areas?

Home-Made Lateral Flow Test Strip Versus POC-CCA Assay for Detection of Active Schistosomiasis in Egypt

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