New

POC-CCA3

An improved, high-quality rapid diagnostic test (RDT) to support progress towards schistosomiasis elimination

Partnership Initiative

New POC-CCA3

Key Improvements

Countries using mass drug administration (MDA) have been effective in reducing schistosomiasis prevalence to low levels but face significant challenges in reaching elimination as a public health problem. One of the reasons is the lack of highly sensitive, high-quality, low-cost schistosomiasis diagnostic tests that help achieve the WHO’s ambitious 2030 NTD road map targets.

An improved version of the WHO-recommended, urine-based POC-CCA RDT has been developed based on recombinant antibodies combined with an expanded in-process and batch release quality control (QC).

Key Improvements: 1. Quality manufacturing and QC
2. Use of recombinant antibodies 3. Standard
inclusion of G-score aid
4. Minimal batch-to-batch
variability 5. More sensitive than Kato-Katz 6. Mobile app under development

Results of Comparative Study

Lamberton et al., manuscript in preparation

This study, conducted in Uganda in 2023, aimed to evaluate the performance of POC-CCA3 in the laboratory and field, comparing it to the current POC-CCA and Kato-Katz.

Study setup
  • Objective: To evaluate the performance of the POC-CCA3 in comparison to the current POC-CCA and Kato-Katz
  • Study setting: School-aged children from a high (Mayuge) and moderate (Tororo) endemic district in Uganda
  • Diagnostics: Kato-Katz stool microscopy, POC-CCA and POC-CCA3 with G-score aid to read intensity of infection
Key results

Batch-to-batch variability between the three POC-CCA batches in the study much higher than that between the three POC-CCA3 batches, with the latter showing negligible differences.

Prevalence estimates for intestinal schistosomiasis based on single urine POC-CCA or POC-CCA3 tests was moderately higher than that based on duplicate Kato-Katz (KK) analysis of a single stool sample in a moderate-endemic region in Uganda, while prevalence estimates in a high-endemic region were considerably higher with the POC-CCA and POC-CCA3 compared to KK.

Testing on 3 subsequent days also resulted in higher prevalence estimates with POC-CCA and POC-CCA3 in the moderate-endemicity region, while 3 day duplicate KK based prevalence in the high endemicity region was closer to the estimates based on the two rapid test versions.

Conclusion

The POC-CCA3 is a more consistent and reliable alternative to the POC-CCA, with similar performance in the field, but with improved manufacturing and quality control resulting in a minimal variation between batches.

Study conducted in collaboration with

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Other Supporting Data

Correlation of POC-CCA and Kato-Katz based prevalence in 25 schools in Uganda. (Based on Stothard et al., 2006 Acta Tropica)

Fold-increase prevalence based on POC-CCA compared to Kato-Katz. (Based on Kittur et al., 2016 AJTMH)

Costs of POC-CCA vs Kato-Katz. (Based on Worrell et al., 2015 AJTMH)

Recommended Use Cases

Prevalence Monitoring

Alternative to Kato-Katz

Impact Assessments

To validate effect of MDA campaigns

Test and Treat Programs

For low endemic settings to help progress towards elimination

Sub-District Surveying

Precision mapping to identify hotspots

Partnership Initiative

This initiative is driven by a strategic partnership that brings together academic expertise in schistosomiasis diagnostics from LUMC (the Netherlands), development and quality control from Mondial Diagnostics (the Netherlands), industrial capabilities of Landcent-EASE (Ghana), and market access support across Africa from PharmaSymbiosis (Ghana).

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NEW POC-CCA3 RDT