Wei-Linfeng L230000434766 2300153515
Wei-Linfeng L230000434766 2300153515
Wei-Linfeng L230000434766 2300153515
:
PH16/1415
MOLECULAR BIOLOGY
Methodology : This test utilizes the novel coronavirus (2019-nCoV) ORF 1ab Gene and the specific conserved sequence of coding
nucleocapsid protein N gene as the target regions which are designed for the conserved sequence of the double-target
genes, to achieve detection of sample RNA through fluorescent signal changes. The PCR detection system uses the positive
internal control, which monitors the presence of PCR inhibitors in test specimens by detecting whether the internal control
signal is normal, to avoid a false negative result.
Significance : This test is intended to be used to achieve qualitative detection of SARS-CoV-2, the causative agent of COVID-19,
extracted from nasopharyngeal swabs and oropharyngeal swabs specimen of patients.
Limitations : The detection of viral RNA is dependent on the viral load if the specimen was collected very early in the infection. Pre-
analytical variables (i.e. specimen quality, handling/ transport condition) may also affect the results. Limit of detection for
this is 200 copies/mL.
Test Platform : PCR Kit: CE IVD Marked Sansure Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit
RNA Extraction Method: Sansure Sample Release Reagent using One Tube Technology
Instrument: Sansure SLAN-96P PCR Machine
Note : The result obtained must be interpreted by the attending physician in correlation with patient's pertinent clinical and
ancillary findings.
DR. PAULO GIOVANNI L. MENDOZA, FPSP DR. DAPHNE C. ANG, MD, DPSP
ED ROSE MAE D. ESTELA, RMT
Lic. No. 98131 Lic. No. 102523
Lic. No. 80178
Medical Technologist Clinical Pathologist Molecular Pathologist
3/F Valucare Bldg. 33 Meralco Ave. Brgy. San Antonio, Pasig City | Tel No. : 8790-8888
**This is a system generated report and if issued without any alteration, this does not require a signature.**