Product name: RT-PCR quantitative COVID-19 assay CE-IVD (48 reactions)
Intended use: The quanty COVID-19 system is a quantitative test that allows the quantification, by means of Real Time PCR, of the N region (nucleocapsid phosphoprotein) of novel Coronavirus (COVID-19).
3 targets of the N* region:
N*1: Real Time Detection and Quantification
N*2: Real Time Detection
N*3: Real Time Detection
The Procedure allows the detection of the RNA target by means a retro-amplification reaction in a microplate. The analysis of the results is made using a Real Time PCR analyzer instrument (thermal cycler integrated with a system for fluorescence detection).
The kit contains enough reagents to perform 48 amplification tests.
1. 3 Positive controls for each region
2. 4 standards for the quantification
3. Mastermix for detection of N1 and N2
4. Mastermix for detection of N3 and IC
5. 48 test for the detection of N1 and N2
6. 48 test for the detection of N3 an IC
Storage: –20°C. RT-PCR quantitative COVID-19 assay CE-IVD (48 reactions) is shipped on dry ice. The kit components should be frozen. An intact and well stored product has a stability of 12 months from the date of production. Do not use beyond the expiration date which appears on the package label.
Repeat thawing and freezing of reagents (more than twice) should be avoided, as this might affect the performance of the assay. The reagents should be frozen in aliquots, if they are to be used intermittently.
For in-vitro diagnostic use Only