Precisão e confiabilidade de um teste imuno-cromatográfico rápido NS1 para diagnóstico DENV-1 no ponto de atendimento e no laboratório

Submitted by Fátima Lopes ([email protected]) on 2017-10-17T18:20:19Z No. of bitstreams: 1 PrecisãoConfiabilidade.pdf: 536187 bytes, checksum: 158c72c6fcda7e358f56efd431f248da (MD5)Approved for entry into archive by Fátima Lopes ([email protected]) on 2017-10-18T13:12:41Z (GMT) No. of bitstreams: 1 PrecisãoConfiabilidade.pdf: 536187 bytes, checksum: 158c72c6fcda7e358f56efd431f248da (MD5)Made available in DSpace on 2017-10-18T13:12:42Z (GMT). No. of bitstreams: 1 PrecisãoConfiabilidade.pdf: 536187 bytes, checksum: 158c72c6fcda7e358f56efd431f248da (MD5) Previous issue date: 2017Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Departamento de Endemias Samuel Pessoa. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.Background: Rapid immunochromatographic tests (ICT) for dengue non-structural protein 1 (NS1) have shown good performance for diagnosing acute-phase dengue in serum in laboratory settings, but rarely have been assessed in whole blood and at point of care (POC). This study compare the accuracy and inter- and intra-observer reliability of the NS1 Bioeasy™ ICT in whole blood at POC versus serum in the laboratory, during a DENV-1 epidemic. Methods: Cross-sectional study involving 144 adults spontaneously demanding care in an emergency department within 4 days of onset of acute febrile illness. Accuracy of NS1 Bioeasy™ ICT was compared in whole blood and serum, both at 15 and 30 min, blinded to the reference RT-PCR or NS1 ELISA. Non-dengue patients were also tested for Zika virus with RT-PCR. Reliability of whole blood and serum readings by the same or different observers was measured by simple kappa (95% CI). Results: At 15 min, sensitivity (Sn) of NS1 Bioeasy™ ICT in whole blood/POC was 76.7% (95% CI: 68.0–84.1) and specificity (Sp) was 87.0% (95% CI: 66.4–97.2). Sn in serum/laboratory was 82% (95% CI: 74.1–88.6) and Sp 100% (95% CI: 85.8–100). Positive likelihood ratio was 5.9 (95% CI: 2.0–17.0) for whole blood/POC and 19.8 (95% CI: 2.9–135.1) for serum/laboratory. Reliability of matched readings of whole blood/POC and serum/laboratory by the same observer (k = 0.83, 95% CI: 0.74–0.93) or different observers (k = 0.81, 95% CI: 0.72–0.92) was almost perfect, with higher discordant levels in the absence of dengue. Results did not differ statistically at 5%. Conclusions: NS1 Bioeasy™ ICT in DENV-1 epidemics is a potentially confirmatory test. Invalid results at 15 min should be reread at 30 min. To optimize impact of implementing ICT in the management of false-negatives it should be incorporated into an algorithm according to setting and available specimen

Correction to: Accuracy and reliability of an NS1 rapid immunochromatographic test for DENV-1 diagnosis at point of care and in the laboratory

Abstract An error occurred during the publication of the original article [1]