Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
Acute respiratory tract infections are significant causes of worldwide morbidity and mortality.1-5 Because many acute respiratory illnesses present with similar symptoms and because there are now different types of treatment available for some, it’s important to quickly identify the viral pathogen causing symptoms. Quick and accurate identification can lead to proper treatment within an effective time frame and help prevent further transmission.
From an accuracy standpoint, PCR is the gold standard. Beyond accuracy, which viral pathogens need to be tested often depends on a number of variables. Today, most labs utilize a mix of standalone and multiplex tests to most closely meet the need. There isn’t always a perfect fit and sometimes, duplication occurs and/or they can’t include exactly what is needed for the situation. Additionally, there is often an algorithm … a set of pathogens tested first … followed by a reflex or follow up test for certain patients or situations. Today, that adds to the turnaround time - delaying treatment and care instructions.
cobas® Respiratory flex for use on the cobas® 5800/6800/8800 systems is an automated, multiplex, nucleic acid test that utilizes real-time polymerase chain reaction (PCR) and temperature activation of signal (TAGS) technology for simultaneous in vitro qualitative detection and differentiation of up to 12 viral results. It also gives labs that flexibility to tailor to test just what’s needed. Existing cobas® 5800/6800/8800 systems are ready right now without any system hardware or system software upgrade required. Labs can now simplify respiratory testing logistics by offering a customizable solution out of one test kit.
| Keyaraeters | Details |
|---|---|
| Targets | Influenza A virus, influenza B virus, respiratory syncytial virus (RSV), SARS-CoV-2, adenovirus (species B, C and E), human metapneumovirus, human rhinovirus/enterovirus, common human coronaviruses (229E, HKU1,NL63, OC43), parainfluenza viruses 1, 2, 3, and 4 |
| Sample type | nasopharyngeal swab samples collected in Copan Universal Transport Medium System (UTM-RT®) or BD™ Universal Viral Transport System (UVT) or equivalent |
| Minimum amount of sample | 0.4 mL |
| Technology | First assay using Roche’s proprietary TAGS technology (temperature activated generation of signal) to enable higher multiplex within existing hardware and system software. |
| Size and open kit stability | 192 tests; 90 days with 40 re-uses |
Target virus |
PPA |
NPA |
|---|---|---|
Influenza A |
100.0% |
99.1% |
Influenza B |
100.0% |
99.8% |
RSV |
96.0% |
99.8% |
SARS-CoV-2 |
98.4% |
98.2% |
Adenovirus |
100.0% |
98.4% |
Human Metapneumovirus |
96.3% |
99.8% |
Enterovirus and Rhinovirus |
83.9% |
98.4% |
Common Human Coronaviruses (229E, HKU1, NL63, OC43) |
96.4% |
97.3% |
Parainfluenza virus 1 |
100.0% |
99.3% |
Parainfluenza virus 2 |
100.0% |
99.6% |
Parainfluenza virus 3 |
95.8% |
99.9% |
Parainfluenza virus 4 |
97.4% |
99.5% |
* cobas Respiratory flex for use on cobas 5800/6800/8800 systems. Instructions for Use, Pleasanton, CA; Roche Molecular Systems.
