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ERESO_RHODORA
ERESO_RHODORA
PATIENT NAME (LAST, FIRST MIDDLE NAME) PIN OR NO. SPECIMEN CODE:
TEST PRINCIPLE: RNA was extracted using magnetic particle technology and amplified via one-step RT-PCR to detect ORF1ab and N gene
of SARS-CoV-2.
SIGNIFICANCE: SARS-CoV-2 viral RNA will be detected from nasopharyngeal/oropharyngeal swabs and lower respiratory tract specimen
of patients.
LIMITATIONS: Detection sensitivity is dependent on the patient’s viral load during specimen collection and the clinical course of the
disease. Pre-analytic variables like specimen collection, handling and storage might affect the results. Limit of detection
for the test kit is 200 copies/mL
QUALITY CONTROL: Internal control was incorporated in the test to monitor efficient RNA extraction and possible inhibition of RT-PCR.
SARS-CoV-2 Negative and Positive Controls were ran in parallel with the sample to ensure test accuracy and validity.
Performance characteristics have been validated and continuously monitored at Intramuros Molecular Laboratory; this
molecular diagnostic facility has engaged in external proficiency testing as part of quality assurance program.
PERFORMED BY:
MA. QUENNIE CEBRERO, RMT WENSHIE MONTEROLA, RMT JOAN A. GARCINES, RMT
JOAN A. GARCINES, RMT ROSSANA S. TUNGOL, MD Emilio Q. Villanueva III, MD, MSc, DPSP