Low specificity of point-of-care circulating cathodic antigen (POC CCA) diagnostic test in a non-endemic area for schistosomiasis mansoni in Brazil

Graeff-Teixeira, Carlos; Favero, Vivian; Pascoal, Vanessa Fey; Souza, Renata Perotto de; Rigo, Francine de Vargas; Agnese, Luize Hoffmann Dall; Bezerra, Fernando Schemelzer de Moraes; Coelho, Paulo Marcos Zech; Enk, Martin Johannes; Favre, Tereza Cristina; Katz, Naftale; Oliveira, Ricardo Riccio; Reis, Mitermayer Galvão dos; Pieri, Otávio Sarmento

doi:10.1016/j.actatropica.2021.105863

Cited by 56 publications

(56 citation statements)

References 27 publications

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“…In the present study, the findings showed false positive results and fluctuation of band intensity scores and discordant results for the same sample tested by using different POC-CCA batches. The data suggest that POC-CCA testing may not be reliable to be used as a marker for evaluation of drug response, in agreement with findings of other investigators (41)(42)(43)(44).…”

Section: Discussionsupporting

confidence: 87%

“…Assessment of Schistosoma infection diagnosis by urinary antigen detection proved to be less suitable to be used in low and non-endemic areas because of the low accuracy of POC-CCA testing. Antigen detection assays need standardization, evaluation of performance in community and institutional settings and of reproducibility between different batches ( 14 , 41 – 43 ). In the present study, the findings showed false positive results and fluctuation of band intensity scores and discordant results for the same sample tested by using different POC-CCA batches.…”

Section: Discussionmentioning

confidence: 99%

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Case Report: Diagnosis and Assessment of Cure Approaches for Acute Schistosomiasis in Pre-School Children

et al. 2021

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Acute schistosomiasis (AS) manifests with a broad spectrum of clinical features in pediatric populations. Diagnosis may be difficult in the absence of detectable numbers of eggs. As a result, new approaches may be required to achieve an accurate diagnosis. Optimal praziquantel (PZQ) treatment regimen for young children is debatable. Also, the post-treatment response is still poorly evaluated due to the lack of reliable markers. A group of 6 children (a toddler and 5 pre-school children) and one pre-adolescent were investigated for AS clinical manifestations and followed-up for two years after treatment. Ova detection was performed by Kato-Katz (KK) and presence of Schistosoma mansoni DNA was assessed by real-time PCR (rt-PCR) in stool samples. IgG and IgE anti-Schistosoma levels and urinary antigen were detected by ELISA and point-of-care circulating cathodic antigen (POC-CCA) testing in serum and urine, respectively. AS clinical symptoms were present in 5/7 (71.4%) of the infected children, and hypereosinophilia was detected in all of them. Ova detection and serology were positive in only 3/7 (44.9%) and 4/7 (57.1%), respectively. However, real-time PCR (rt-PCR) showed the presence of Schistosoma DNA in 6/7 (85.7%) of the cases, and urinary antigen was detected in all infected children. The long-term follow-up after treatment with three doses of PZQ (80mg/kg/dose), showed high cure rates (CR) as demonstrated by the DNA-based assay as well as reduced levels of side effects. CR based on urinary antigen detection ranged from 28.6 to 100%, being the highest CR due to double testing the 2-year post-treatment samples. The results suggest that high dose and repeated treatment with PZQ might be effective for AS in young children. Also, new laboratory markers should be considered to diagnosis and monitor the drug response.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Case Report: Diagnosis and Assessment of Cure Approaches for Acute Schistosomiasis in Pre-School Children

et al. 2021

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“…50 A recent study by Graeff-Teixeira et al demonstrated unacceptably high rates of positive POC-CCA results in a nonendemic area. 51 In addition, a comparison of communities with long histories of MDA and declining prevalence measured by the KK test demonstrated major discrepancies between two batches of POC-CCA tests, thus leading to concerns about quality control and standardization by the manufacturer. 52 The POC-CCA tests used during our study were from lots 170316032 (2017), 180314027 (2018 and 2019), and 190301016 (2020); as far as we know, none has been associated with unexpected results in other studies.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Point-of-Care Circulating Cathodic Antigen Assay for Monitoring Mass Drug Administration in a Schistosoma mansoni Control Program in Western Kenya

Straily

Kavere²,

Wanja³

et al. 2022

The American Journal of Tropical Medicine and Hygiene

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The WHO guidelines for monitoring and evaluating Schistosoma mansoni control programs are based on the Kato-Katz (KK) fecal examination method; however, there are limitations to its use, particularly in low prevalence areas. The point-of-care urine circulating cathodic antigen (POC-CCA) assay has emerged as a useful tool for mapping schistosomiasis prevalence, but its use in monitoring and evaluating control programs has not been evaluated. Before POC-CCA can be used for these programs, it must be determined how previous guidance based on the KK method can be translated to the POC-CCA assay; furthermore, its performance in different endemicity settings must be evaluated. Urine and stool specimens were collected from students attending public primary schools in western Kenya before mass treatment with praziquantel at baseline (51 schools), year 1 (45 schools), year 2 (34 schools), and year 3 (20 schools). Prevalence and infection intensity were determined by the KK method and POC-CCA assay. Changes in prevalence and intensity were compared within the strata of schools grouped according to the baseline prevalence determined by the KK method (0–10%, > 10–20%, > 20%). The prevalence determined by the POC-CCA assay was higher than that determined by the KK method at all time points for all strata. The prevalence determined by the KK method decreased from baseline to 2 and 3 years, as did infection intensity (with one exception). A corresponding decrease was not always replicated by the POC-CCA assay results. The POC-CCA assay did not perform as expected, and the concordance of results of the two tests was poor. Furthermore, there are emerging concerns regarding the specificity of the POC-CCA assay. Therefore, it is impossible to translate historical data and programmatic guidelines based on the KK method results to the POC-CCA assay.

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“…37 Since our study, the format of the POC-CCA has been changed, and some issues with batch-to-batch variation have been reported. 38 This mainly applies to the very low prevalence areas in Brazil 39 ; in low-to-moderate areas, the POC-CCA provides a more accurate estimate of the true prevalence of S. mansoni compared with Kato-Katz thick smear readings. 40 Caution must always be taken with the use of different production batches of rapid diagnostic tests, comparing the performance of consecutive batches using a set of reference samples.…”

Section: Discussionmentioning

confidence: 99%

Accuracy of Two Circulating Antigen Tests for the Diagnosis and Surveillance of Schistosoma mansoni Infection in Low-Endemicity Settings of Côte d’Ivoire

Assaré

Tra-Bi

Coulibaly

et al. 2021

The American Journal of Tropical Medicine and Hygiene

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In low-endemicity settings, current tools for diagnosis and surveillance of schistosomiasis are often inaccurate in detecting true infection. We assessed the accuracy of an up-converting phosphor lateral flow circulating anodic antigen (UCP-LF CAA) test and a point-of-care circulating cathodic antigen (POC-CCA) urine cassette test for the diagnosis of Schistosoma mansoni. Our study was conducted in eight schools of western Côte d’Ivoire. Fifty children, aged 9 to 12 years, were enrolled per school. From each child, a single urine specimen and two stool specimens were collected over consecutive days for diagnostic workup. Urine samples were subjected to UCP-LF CAA and POC-CCA tests. From each stool sample, triplicate Kato-Katz thick smears were examined. Overall, 378 children had complete data records. The prevalence of S. mansoni, as assessed by six Kato-Katz thick smears, was 4.0%. The UCP-LF CAA and POC-CCA tests revealed S. mansoni prevalence of 25.4% and 30.7%, respectively, when considering trace results as positive, and prevalence of 23.3% and 10.9% when considering trace results as negative. In the latter case, based on a composite gold standard, the sensitivity of UCP-LF CAA (80.7%) was considerably higher than that of POC-CCA (37.6%) and six Kato-Katz thick smears (13.8%). The negative predictive value of UCP-LF CAA, POC-CCA, and six Kato-Katz thick smears was 92.8%, 79.8%, and 74.1%, respectively. Our results confirm that UCP-LF CAA is more accurate than Kato-Katz and POC-CCA for the diagnosis of S. mansoni in low-endemicity settings.

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Low specificity of point-of-care circulating cathodic antigen (POC CCA) diagnostic test in a non-endemic area for schistosomiasis mansoni in Brazil

Cited by 56 publications

References 27 publications

Case Report: Diagnosis and Assessment of Cure Approaches for Acute Schistosomiasis in Pre-School Children

Case Report: Diagnosis and Assessment of Cure Approaches for Acute Schistosomiasis in Pre-School Children

Evaluation of the Point-of-Care Circulating Cathodic Antigen Assay for Monitoring Mass Drug Administration in a Schistosoma mansoni Control Program in Western Kenya

Accuracy of Two Circulating Antigen Tests for the Diagnosis and Surveillance of Schistosoma mansoni Infection in Low-Endemicity Settings of Côte d’Ivoire

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