COVID-19 RT-PCR DIAGNOSTIC TEST

Quick Details

DIAGNOSTIC PARAMETERS	COVID-19 INFECTION- POSITIVE/NEGATIVE
TEST TIME- RAPID TEST	20 MINUTES FOR SINGLE SAMPLE (FULLY AUTOMATED WITH IPONATIC MACHINE)
TEST TIME- FAST SPEED TEST	155 MINUTES FOR 96 SAMPLES, 1000 SAMPLES DAILY (FULLY AUTOMATED EXTRACTION BY NATCH CS MACHINE)
TEST TIME- POOLED SAMPLING TEST	200 MINUTES FOR 960 SAMPLES, 6000 SAMPLES DAILY (FULLY AUTOMATIC EXTRACTION WITH NATCH CS2 MACHINE)
LIMIT OF DETECTION	200 COPIES/ML FOR RAPID & FAST SPEED TEST, 50 COPIES/ML FOR POOLED SAMPLING TEST
EU CE MARKING	FULLY REGISTERED
US FDA EUA	FULLY REGISTERED
BRAZIL ENVISA	FULLY REGISTERED
WHO	EUL ONGOING
CFDA	FULLY REGISTERED
ISO	13485
SAMPLING TYPE	NASAOPHARYNGEAL SWAB, OROPHARYNGEAL SWAB, ALVEOLAR LAVAGE FLUID, SPUTUM, SERUM, WHOLE BLOOD AND FECES.
COMPATIBLE INSTRUMENTS	SLAN-96P/ ABI7500/ ABI Q55/ LIFE TECHNOLOGIES QUANTSTUDIO 5/ ROCHE COBAS 480/ ROCHE Z480/ MA-6000 PCR INSTRUMENT.
TECHNICAL PLATFORM	ONE-TUBE FAST SPEED RELEASE/ MAGNETIC BEADS TECHNOLOGIES
PACKING SPECIFICATION	24 TEST/ KIT, 48 TEST/ KIT
BIOSAFETY	HIGH
OPERATION TEMPERATURE	ROOM TEMPERATURE
EXPIRATION DATE	12 MONTHS
LYSIS BUFFER WITH PATHOGEN INACTIVATION	YES

OVERVIEW:
The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasoryngeal swabs, ororyngeal (Throat) swabs, anterior nasal swabs, mid-turbinate swabs, nasal washes and nasal aspirated from individuals who are suspected of COVID-19 by their healthcare provider.