Logix Smart ABC (Influenza A/B, SARS-CoV-2) Test Kit
Logix Smart ABC (Influenza A/B, SARS-CoV-2) Test Kit
1. INTENDED USE
The Logix Smart ABC (Influenza A/B, SARS-CoV-2) Test kit is a research use only multiplex test, based on real-time PCR (qPCR) technology, for the simultaneous qualitative detection of the Influenza A (INFA), Influenza B (INFB), and SARS-CoV-2 (COVID-19) specific RNA.
For research use only (RUO). Not for use in diagnostics procedures.
2. KIT COMPONENTS
|
Lid Color |
Component |
Symbol |
Catalog Number |
Description |
Amount |
|
Black |
Logix Smart™ ABC Master Mix |
MM |
ABC-MM- 001 |
Proprietary blend of CoPrimers™ and PCR reagents |
1x1000μL (100 reactions) |
|
Red |
Logix Smart™ ABC Positive Control |
PC |
ABC-PC- 001 |
Proprietary blend of target templates |
1x1000μL (100 reactions) |
|
Clear |
Nuclease-Free Water |
NTC |
GEN-NF-001 |
DNase/RNase-free water |
1x1000μL (100 reactions) |
3 PRODUCT DESCRIPTION
The Logix Smart™ ABC kit is a research use only multiplex test, based on real-time polymerase chain reaction technology. It tests for the presence or absence of ribonucleic acid (RNA) of the Influenza A, Influenza B, and SARS-CoV-2 viruses.
The Logix Smart™ ABC test includes an internal control to identify possible qPCR inhibition, confirm the integrity of the reagents, and verify the quality of sample extraction.
The Logix Smart™ ABC test also includes a positive control which includes three synthetic RNA molecules carrying sequences that are homologous to Influenza A (INFA), Influenza B (INFB), and SARS-CoV-2 (COVID-19) viruses and are targeted by this multiplex assay.Positive controls represent a source of cross-contamination. Precautions should be taken to prevent and minimize the risk.
CoPrimers™ included in the Logix Smart™ ABC test are:
- CoPrimers™ that are targeting INFA are labelled with the FAM™ fluorophore
- CoPrimers™ that are targeting INFB are labelled with the CAL Fluor® Orange 560 fluorophore
- CoPrimers™ that are targeting COVID-19 are labelled with the Quasar® 670 fluorophore
- CoPrimers™ that are targeting
Regulatory Clearance
In November 2020, the Logix Smart Influenza A/Influenza B/COVID-19 (“ABC”) Test kit received CE marking approval, the principle regulatory clearance allowing the test to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of COVID-19 in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval
| Intended Use | The Logix Smart ABC (Influenza A/B, SARS-CoV-2) Test kit is a research use only multiplex test, based on real-time PCR (qPCR) technology, for the simultaneous qualitative detection of the Influenza A (INFA), Influenza B (INFB), and SARS-CoV-2 (COVID-19) specific RNA. |
|---|---|
| Sample Type | Lower respiratory tract fluids (bronchoalveolar lavage - BAL, tracheal aspirate, and sputum), and upper respiratory tract fluids (Nasopharyngeal and oropharyngeal swabs). |
| User | Laboratory technician trained in molecular diagnostics procedures |
| Clinical Matrix used for analytical verification | Lower respiratory tract fluid (Bronchoalveolar Lavage (BAL) and sputum), upper respiratory tract fluid (Nasopharyngeal fluid), and serum |
| Analytical Specificity (wet-test or in silico analysis) | DOES NOT cross-react with the following microorganisms: SARS-CoV, MERS-CoV, Human coronaviruses (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1), Adenovirus, Influenza A H3N2, Novel Influenza A H1N1, Influenza B, Influenza C, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Respiratory syncytial virus (subtype A), Respiratory syncytial virus (subtype B), Parechovirus, Candida albicans, Corynebacterium diphtheriae, Legionella non-pneumophila, Bacillus anthracis, Moraxella catarrhalis, Neisseria elongata, Neisseria meningitides, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus salivarius, Leptospirosis, Chlamydia psittaci, Coxiella burnetii (Q-Fever), Staphylococcus epidermidis, Enterovirus, Rhinovirus, Haemophilus Influenzae, Mycobacterium tuberculosis, Bordetella parapertussis, Mycoplasma |
| Time to detection | 63-90 minutes, depending on the machine used |
| Extraction System | QIAamp Viral RNA Mini kit (QIAGEN) |
| Thermal cycler compatibility | CoDx Box (Bio Molecular Systems) Eco 48 (PCRmax) 2 channels: FAM and CF610 (ROX) |