cobas SARS-CoV-2 Test, pack/192

General description:
cobas SARS-CoV-2 for use on the cobas 6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19. cobas SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the
techniques of real-time PCR and in vitro diagnostic procedures. cobas SARS-CoV-2 is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas 6800/8800 Systems consist of the sample supply module,
the transfer module, the processing module, and the analytic module.

Technical Specifications:
Principle: Automated real-time RT-PCR Test format: RT- PCR Kit.
Kit size: 192 cassettes.
Specimen type: Nasal, nasopharyngeal swabs and oropharyngeal.
Transport media for nasal swabs: cobas® PCR Media Dual Swab Kit, cobas® PCR Media Uni Swab Kit, cobas® PCR Media Kit for nasal swabs, 0.9% Physiological Saline,
Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT)
Transport media for nasopharyngeal andoropharyngeal swab: Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT)
Time to result: Results are available within less than 3.5 hours after loading the sample on the system.
Specimen volume: 0.6 mL (amount of sample) 0.4 µL (sample processing volume)

Manufacturer product reference: 9175431190

Items supplied with:
(A) cobas SARS-CoV-2 test pack/192 tests
·Proteinase Solution (PASE) – 22.3ml
·RNA Internal Control (RNA IC) – 21.2ml
·Elution buffer (EB) – 21.2ml
·Master mix Reagent 1 (MMX-R1) – 7.5ml
·SARS-CoV-2 Master Mix Reagent 2 (SARS-CoV-2 MMX-R2) – 9.7ml
(B) SARS-CoV-2 Positive Control (SARS-CoV-2 (+) C – 16ml (16 x 1ml)
(C) cobas Buffer Negative Control (BUF (-) C) – 16ml (16 x 1ml)

Items Required but not supplied with kit
·Instrument: cobas 6800/8800 Systems.
·Accessories/consumables for use on cobas 6800/8800 Systems.
·Sample preparation/Extraction Reagents for use on cobas 6800/8800 Systems.
Additional items/bundles required to run cobas SARS-CoV-2 is available for procurement through UNICEF supply. For latest updates check Product Reference Notes

Shelf life:
12 months from the date of manufacture.

Storage condition:
Must be stored at 2–8°C.