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Assays for the Specific Growth Rate and Cell-binding Ability of Rotavirus
Published on: January 28, 2019
Performance analysis of two immunochromatographic assays for the diagnosis of rotavirus infection
S De Grazia1, F Bonura1, A Pepe1
1Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy.
Insights
Two commercial rotavirus tests, CerTest and Vikia, were evaluated for diagnosing acute gastroenteritis in children. Vikia showed higher sensitivity, while CerTest offered greater specificity, with both demonstrating substantial agreement with Real-time PCR.
Area of Science:
- Virology
- Clinical Diagnostics
- Pediatric Infectious Diseases
Background:
- Group A rotaviruses (RVAs) are a leading cause of acute gastroenteritis (AGE) in young children globally.
- Several diagnostic methods exist, including latex agglutination, ELISA, and immunochromatographic tests (ICTs).
- Evaluating the performance of commercially available rapid diagnostic tests is crucial for effective RVA management.
Purpose of the Study:
- To retrospectively evaluate the diagnostic performance of two one-step chromatographic immunoassays, CerTest Rotavirus+Adenovirus and Vikia Rota-Adeno.
- To compare these ICTs against Real-time PCR as the reference standard for RVA detection.
- To assess the clinical utility and accuracy of these rapid tests in a pediatric population with AGE.
Main Methods:
- Retrospective analysis of 2096 stool samples from children hospitalized with AGE.
- Samples were initially screened using CerTest (1467 samples) and Vikia (629 samples).
- Real-time PCR was used as the reference test to re-evaluate all samples and calculate performance metrics.
Main Results:
- Vikia demonstrated higher sensitivity (94%) compared to CerTest (85%).
- CerTest exhibited higher specificity (93%) than Vikia (89%).
- Both tests showed substantial agreement with Real-time PCR (κ=0.79), with discrepancies linked to low viral loads (high Ct values).
- No cross-reactivity with other common viral pathogens was observed.
- Both assays detected a wide range of circulating RVA genotypes.
Conclusions:
- Both CerTest and Vikia offer satisfactory efficacy for RVA diagnosis in children with AGE.
- The choice between tests may depend on whether higher sensitivity (Vikia) or specificity (CerTest) is prioritized.
- Real-time PCR remains essential for confirming results, especially in cases of suspected low viral load infections.
Abstract:
Group A rotaviruses (RVAs) are the primary cause of acute gastroenteritis (AGE) in young children worldwide. Several commercial tests including latex agglutination, enzyme-linked assays (ELISA) and immunochromatographic tests (ICT) have been developed for the diagnosis of RVA infection. In the present study, the performance of two commercially available one-step chromatographic immunoassays, CerTest Rotavirus+Adenovirus (Biotec S.L, Zaragoza, Spain) and Vikia Rota-Adeno (bioMerieux SA, Lyon, France) were retrospectively evaluated using Real-time PCR as reference test. Re-testing by Real-time PCR of 2096 stool samples of children hospitalized with AGE previously screened by ICTs (1467 by CerTest and 629 by Vikia) allowed to calculate higher sensitivity for Vikia (94% vs 85% of CerTest) and higher specificity for CerTest (93% vs 89% of Vikia). Accordingly, higher Positive Predictive Values (87% vs 78%) and Positive Likelihood Ratios (12.32 vs 8.8) were found for CerTest and lower Negative Predictive Values (91% vs 97%) and Negative Likelihood Ratios (0.16 vs 0.06) for Vikia. However, both CerTest and Vikia showed a substantial agreement (κ=0.79) with the Real-time PCR. A correlation between false negative results by ICTs and high Cycle Threshold values of Real-time PCR, indicative of low viral load, was observed. False positive results by the two ICT assays were not related to Norovirus, Adenovirus or Astrovirus infections, therefore the risk of cross-reactions was excluded. Both CerTest and VIKIA were able to detect the wide range of RVA genotypes circulating over the study period (including G1P[8], G2P[4], G3, G4, G9 and G12P[8]). The results of the present study showed a satisfactory efficacy of the two diagnostic tests analyzed.
