Description
- The Solana Strep Complete Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A B-hemolytic Streptococcus (Streptococcus pyogenes), and pyogenic Group C/G (streptococcus dysgalactiae) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat
- A throat swab sample or an aliquot of liquid transport media is lysed by simple heat treatment, diluted, and added to two Reaction Tubes, one containing primers and probes specific for Group A Strep, the other containing primers and probes for strep dysgalactiae HDA reagents including primers specific for the amplification of the DNAase B (sdaB) sequence as well as sequence specific probes
- Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s four USB ports
Product Specs
| Item Number | 1042372 |
|---|---|
| Catalog Number | M305 |
| UOM | KT |
| Level 1 Family Description | Lab-Non-Waived Lab |
| Level 2 Category Description | Lab-Molecular - NW |
| Level 3 Group Description | Molecular Reagents - NW |
| Level 4 Sub-Category Description | Strep - Molecular - NW |
| Application | Respiratory Test Kit |
| Brand | Solana Strep Complete |
| Buy American Act (BAA) Compliant | Yes |
| CLIA Classification | CLIA Moderate Complexity |
| CLIA Classified | CLIA Non-Waived |
| Contents 1 | (48) Strep Dilution Buffer Tubes, (48) Strep Complete Lysis Buffer Tubes, (48) GAS Reaction Tubes, (48) Strep C/G Reaction Tubes |
| Country of Origin | United States |
| For Use With | For Solana Instrument |
| Is_ECAT | N |
| Is_GSA | Y |
| Is_VA | N |
| Manufacturer | Quidel |
| Manufacturer # | M305 |
| McKesson # | 1042372 |
| Number of Tests | 48 Tests |
| Purchase Program Type | Standard Purchase |
| Reading Type | Machine Read |
| Sample Type | Throat Swab Sample |
| Specialty | Molecular |
| Storage Requirements | Requires Refrigeration |
| Test Format | Tube Format |
| Test Kit Type | Rapid |
| Test Name | Group A B-hemolytic Streptococcus and Pyogenic Group C/G Strep |
| Test Type | Molecular Diagnostic |
| Time to Results | 35 Minute Results |
| Trade Agreement Act (TAA) Compliant | Yes |
| UNSPSC Code | 41116129 |