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1. This test targets the Sars-CoV-2 N (Nucleocapsid), S (Spike protein) and ORF1ab genes.
2. Limit of detection = 250 copies / mL (95% LOD).
3. Method developed and validated by the laboratory itself in accordance with RDC 302 of October 13, 2005, Art.5.5.5.1. and
the standards for tests developed by the laboratory (LDTs) of the College of American Pathologists (CAP).
4. The "Not Detected" result does not rule out the presence of the virus in a concentration below the detection limit of the test.
5. It is important to correlate the result of this exam to the patient's clinical condition and other radiological and laboratory
findings.
6. Laboratory certified for the diagnosis of COVID-19 by RT-PCR by the Instituto Adolfo Lutz (IAL-SP). OF.SP, March 27,
2020.
REFERENCE:
Price TK et al. Performance Characteristics of Severe Acute Respiratory Syndrome Coronavirus 2 PCR Tests in a Single
Health System: Analysis of >10,000 Results from Three Different Assays. J Mol Diagn. 2020 Dec 5:S1525-1578(20)30583-3.
doi: 10.1016/j.jmoldx.2020.11.008.
Released by: Joao Paulo Baptista de Jesus de Souza CRBIO-RJ 121514/02 (06/27/2022 19:11 BRT)
Responsible: Dr. Alberto Chebabo - CRM:52-47774-3
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