Performance analysis of two immunochromatographic assays for the diagnosis of rotavirus infection.
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.
Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy. Electronic address: simona.degrazia@unipa.it.
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De Grazia
Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy.
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Bonura
Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy.
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Pepe
Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy.
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Li Muli
Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy.
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Cappa
Unità Operativa di Microbiologia e Virologia, Ospedale Civico e Di Cristina, ARNAS, Palermo, Italy.
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Collura
Unità Operativa di Microbiologia e Virologia, Ospedale Civico e Di Cristina, ARNAS, Palermo, Italy.
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Terranova
Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy.
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Urone
Unità Operativa di Microbiologia e Virologia, Ospedale Civico e Di Cristina, ARNAS, Palermo, Italy.
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Di Bernardo
Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy.
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Matranga
Dipartimento di Scienze per la Promozione della Salute e Materno Infantile "G. D'Alessandro", Università di Palermo, Italy.
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Giammanco
D002675:Child, Preschool; D002846:Chromatography, Affinity / Q000379:methods*; D003951:Diagnostic Errors; D005260:Female; D005759:Gastroenteritis / Q000175:diagnosis; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007558:Italy; D008297:Male; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D012400:Rotavirus Infections / Q000175:diagnosis*; D012680:Sensitivity and Specificity
Immunochromatography; Rotavirus; Sentitivity; Specificity