RESUMO
To meet the unprecedented requirement of diagnostic testing for SARS-CoV-2, a large number of diagnostic kits were authorized by concerned authorities for diagnostic use within a short period of time during the initial phases of the ongoing pandemic. We undertook this study to evaluate the inter-test agreement and other key operational features of 5 such commercial kits that have been extensively used in India for routine diagnostic testing for COVID-19. The five commercial kits were evaluated, using a panel of positive and negative respiratory samples, considering the kit provided by National Institute of Virology, Indian Council of Medical Research (2019-nCoV Kit) as the reference. The positive panel comprised of individuals who fulfilled the 3 criteria of being clinically symptomatic, having history of contact with diagnosed cases and testing positive in the reference kit. The negative panel included both healthy and disease controls, the latter being drawn from individuals diagnosed with other respiratory viral infections. The same protocol of sample collection, same RNA extraction kit and same RT-PCR instrument were used for all the kits. Clinical samples were collected from a panel of 92 cases and 60 control patients, who fulfilled our inclusion criteria. The control group included equal number of healthy individuals and patients infected with other respiratory viruses (n = 30, in each group). We observed varying sensitivity and specificity among the evaluated kits, with LabGun COVID-19 RT-PCR kit showing the highest sensitivity and specificity (94% and 100% respectively), followed by TaqPath COVID-19 Combo and Allplex 2019-nCoV assays. The extent of inter-test agreement was not associated with viral loads of the samples. Poor correlation was observed between Ct values of the same genes amplified using different kits. Our findings reveal the presence of wide heterogeneity and sub-optimal inter-test agreement in the diagnostic performance of the evaluated kits and hint at the need of adopting stringent standards for fulfilling the quality assurance requirements of the COVID-19 diagnostic process.
Assuntos
Teste para COVID-19 , COVID-19 , Humanos , Pandemias , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Sensibilidade e EspecificidadeRESUMO
Background. Anxiety and panic are known to be associated with bronchial asthma with variety of impact on clinical presentation, treatment outcome, comorbidities, quality of life, and functional disability in patients with asthma. This study aims to explore the pattern of panic symptoms, prevalence and severity of panic disorder (PD), quality of life, and disability in them. Methods. Sixty consecutive patients of bronchial asthma were interviewed using semistructured proforma, Panic and Agoraphobia scale, WHO Quality of life (QOL) BREF scale, and WHO disability schedule II (WHODAS II). Results. Though 60% of the participants had panic symptoms, only 46.7% had diagnosable panic attacks according to DSM IV TR diagnostic criteria and 33.3% had PD. Most common symptoms were "sensations of shortness of breath or smothering," "feeling of choking," and "fear of dying" found in 83.3% of the participants. 73.3% of the participants had poor quality of life which was most impaired in physical and environmental domains. 55% of the participants had disability score more than a mean (18.1). Conclusion. One-third of the participants had panic disorder with significant effect on physical and environmental domains of quality of life. Patients with more severe PD and bronchial asthma had more disability.