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Mendeley readers
| Title |
Development of a validation protocol method for nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus
|
|---|---|
| Published in |
Anais da Academia Brasileira de Ciências, January 2022
|
| DOI | 10.1590/0001-3765202220211321 |
| Pubmed ID | |
| Authors |
Marcele C C DA Silva, Letícia C L DE Abreu, Flavia A DO Carmo, Carlos R Rodrigues, Valeria P DE Sousa, Lucio M Cabral |
| Abstract |
The concern about the risks of viral infections transmission through blood transfusion has led into a search for improvements on screening tests used for the selection of blood donors. Molecular biology techniques applied in researches of viral genomes, known as Nucleic Acid-amplification-Test (NAT), represent a technology capable of increasing transfusion safety by shortening the diagnostic window period. In Brazil, the implementation of this technology for the detection of HIV, HCV and HBV occurred due to the implantation of the NAT Kit - produced by Immunobiological Technology Institute (Biomanguinhos-FIOCRUZ), in the Brazilian blood centers. The National Health Surveillance Agency attaches great importance to validation, since it standardizes, disciplines and regulates criteria for the registration of health products. This work aims to establish a protocol of performance validation by real-time PCR method, taking as the object of study the Bio-Manguinhos NAT Kit, in order to update the product registration or to meet any future needs to ensure all regulatory requirements for the performance validation of the real-time PCR diagnostic kit. The protocol developed followed the ICH recommendations. The results revealed that the adopted methodology contemplates the necessary requirements for compliance with the Brazilian legislation, as well as the established validation parameters. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Comoros | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 5 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 5 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 1 | 20% |
| Lecturer | 1 | 20% |
| Unknown | 3 | 60% |
| Readers by discipline | Count | As % |
|---|---|---|
| Nursing and Health Professions | 1 | 20% |
| Business, Management and Accounting | 1 | 20% |
| Unknown | 3 | 60% |