ABSTRACT
Molecular diagnosis of SARS-CoV-2 in developing countries is still a big challenge. The reference standard, RT-qPCR, recommended by WHO, is not widely available, difficulting early identification of cases. Furthermore, the transport logistic between the sample collection point and the laboratory facilities can alter the samples, producing false negative results. RT-LAMP is a cheaper, simpler molecular technique that can be an interesting alternative to be offered in hospital laboratories. We present the evaluation of a RT-LAMP for diagnosis of SARS-CoV-2 in two steps: the laboratory standardization and the clinical validation, comparing it with the standard RT-qPCR. In the standardization phase, limit of detection and robustness values were obtained using RNA from a Peruvian SARS-CoV-2 strain. It presented 100% agreement between triplicates (RT-LAMP agreement with all RT-qPCR reactions that presented Ct [≤] 30) and robustness (RT-LAMP successful reactions with 80% reaction volume and 50% primer concentration). 384 nasal and pharyngeal swabs collected from symptomatic patients and stored in the INS biobank were tested and we obtained 98.75%, 87.41%, 97.65% and 92.96% for specificity, sensitivity, positive predictive value and negative predictive values respectively. Then, 383 samples from symptomatic patients with less than 15 days of disease, were tested both with the RT-LAMP and with the RT-qPCR, obtaining e 98.8%, 88.1%, 97.7% y 93.3% of specificity, sensitivity, positive predictive value and negative predictive values respectively. The laboratory standardization and the clinical validation presented the same value by Kappa-Cohen index (0.88) indicating an almost perfect agreement between RT-LAMP and RT-qPCR for molecular detection of SARS-CoV-2. We conclude that this RT-LAMP protocol presented high diagnostic performance values and can be an effective alternative for COVID-19 molecular diagnosis in hospitals, contributing to early diagnosis and reducing the spread of virus transmission in the Peruvian population.
ABSTRACT
The objective of the study was to determine compliance with hepatitis-B virus (HBV) in newborns in Lima and Callao. A descriptive, cross-sectional, multicenter-design study was conducted in high level public and private hospitals. Information on vaccination corresponds to newborns during one week of 2015 and was obtained through consultations with parents and review of health service reports. The study was conducted in 12 health facilities including 935 mothers and newborns. Vaccination coverage within 24 hours of life was 85.1%, according to the parents' report; and 88.7%, according to the health services' report. It is concluded that the coverage of HBV vaccination in newborns within 24 hours of life was important, but still far from the ideal goals proposed by the Ministry of Health and the World Health Organization.
El objetivo del estudio fue determinar el cumplimiento de la vacunación contra el virus de la hepatitis B (VHB) en recién nacidos de Lima y Callao. Estudio de diseño descriptivo, transversal y multicéntrico, realizado en hospitales de alto nivel, públicos y privados. La información sobre la vacunación corresponde a recién nacidos durante una semana del 2015, y fue obtenida mediante consultas a los padres y revisión de reporte de los servicios de salud. El estudio se realizó en 12 establecimientos de salud incluyéndose a 935 madres y recién nacidos. La cobertura de vacunación dentro de las 24 horas de vida fue de 85,1% según el reporte de padres y 88,7% según el reporte de los servicios de salud. Se concluye que la cobertura la vacunación contra el VHB en recién nacidos dentro de las 24 horas de vida fue importante, pero aún alejada de metas ideales propuestas por el Ministerio de Salud y la Organización Mundial de la Salud.
Subject(s)
Hepatitis B Vaccines/administration & dosage , Hepatitis B/prevention & control , Vaccination Coverage/statistics & numerical data , Adolescent , Adult , Cross-Sectional Studies , Female , Guideline Adherence/statistics & numerical data , Humans , Infant, Newborn , Male , Middle Aged , Mothers , Peru , Urban Population , Young AdultABSTRACT
RESUMEN El objetivo del estudio fue determinar el cumplimiento de la vacunación contra el virus de la hepatitis B (VHB) en recién nacidos de Lima y Callao. Estudio de diseño descriptivo, transversal y multicéntrico, realizado en hospitales de alto nivel, públicos y privados. La información sobre la vacunación corresponde a recién nacidos durante una semana del 2015, y fue obtenida mediante consultas a los padres y revisión de reporte de los servicios de salud. El estudio se realizó en 12 establecimientos de salud incluyéndose a 935 madres y recién nacidos. La cobertura de vacunación dentro de las 24 horas de vida fue de 85,1% según el reporte de padres y 88,7% según el reporte de los servicios de salud. Se concluye que la cobertura la vacunación contra el VHB en recién nacidos dentro de las 24 horas de vida fue importante, pero aún alejada de metas ideales propuestas por el Ministerio de Salud y la Organización Mundial de la Salud.
ABSTRACT The objective of the study was to determine compliance with hepatitis-B virus (HBV) in newborns in Lima and Callao. A descriptive, cross-sectional, multicenter-design study was conducted in high level public and private hospitals. Information on vaccination corresponds to newborns during one week of 2015 and was obtained through consultations with parents and review of health service reports. The study was conducted in 12 health facilities including 935 mothers and newborns. Vaccination coverage within 24 hours of life was 85.1%, according to the parents' report; and 88.7%, according to the health services' report. It is concluded that the coverage of HBV vaccination in newborns within 24 hours of life was important, but still far from the ideal goals proposed by the Ministry of Health and the World Health Organization.
