rTEST COVID-19 qPCR Allplex
Manufactured by MultiplexDX s.r.o., Slovakia - www.multiplexdx.com
Device identification number
2027
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Saliva, Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The rTEST COVID-19 qPCR Allplex kit is a qualitative in vitro diagnostic test designed to detect the presence of SARS-CoV-2 genetic material in biological samples obtained primarily from the human upper airways (nose and nasopharynx). The kit is intended exclusively for use in a diagnostic laboratory with the appropriate equipment, safety standards, and properly trained personnel. The rTEST COVID-19 qPCR Allplex kit is among the first fully room temperature stable diagnostic kits to detect genomic RNA of SARS-CoV-2.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Qualitative
Time
80 minutes
Subclass
JRC-S
LOD
4 cpr
Positive control
PC BMC5 consists of isolated genomic RNA of SARS-CoV-2 spiked with human RNA
Negative control
PCR water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements