商品编号


M306



品牌


Quidel



公司


Quidel,inc.



公司分类


Solana



Size

48 tests

商品信息

Description:
Solana RSV + hMPV Assay Kit
Features & Benefits:







The Solana RSV + hMPV Assay is a rapid qualitative
in vitro
diagnostic test for the detection and differentiation of Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV) viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.

The Solana RSV + hMPV Assay amplifies and detects viral RNA present in transport media containing nasopharyngeal or nasal swab specimens obtained from symptomatic patients.

The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to RSV and/or hMPV using isothermal Reverse Transcriptase — Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes which is performed in the Solana instrument.

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 five USB ports. Solana RSV+hMPV is also supported by the power of Virena
?
.










Feature
Benefit



RT-HDA technology
Rapid method of isothermal nucleic acid amplification that does not require thermal cycler



Lyophilized Master Mix reagent
Easy-to-use format, just add processed sample to rehydrate



Small, easy-to-use instrument
Eliminates the need for dedicated molecular space and costly capital equipment, allowing for testing in smaller labs



CLIA moderately complex
Requires minimal training



Refrigerated storage
No freezer needed, 2?C to 8?C storage



Long shelf life
Currently 12 months from date of manufacture



Room temperature set up
No ice or cooling block required












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Nasal swabs and nasopharyngeal swabs in transport media* obtained from patients symptomatic of respiratory infection
*
BD
/Copan VTM, Remel M4, Remel M4RT, Remel M5, Remel M6, or Copen eSwab


Time to results
Approximately 45 minutes



Reagent storage conditions
Lysis and Reaction Tubes; 2?C to 8?C



Control storage conditions
2?C to 8?C



Sample preparation storage conditions
Specimens should be collected, transported, stored, and processed according to CLSI M41-A and stored at 2°C to 8°C until tested. Specimens collected in
BD
UTM, Remel M4, M4RT, M5, and M6 (3 mL), and Copan eSwab are stable at 2°C to 8°C for up to 9 days



PPA (PCR)
RSV: 95.5% (95% CI 91.0% to 97.8%)
hMPV: 95.6% (95% CI 89.1% to 98.3%)


NPA (PCR)
RSV: 99.9% (95% CI 91.0% to 97.8%)
hMPV: 99.8% (95% CI 99.6% to 99.9%)


LOD (RSV)
RSV A, A2 (VR-1540): 7.9x10
3
TCID
50
/mL
RSV B, Wash/18537/62 (VR-1580): 3.9x10
2
TCID
50
/mL


LOD (hMPV)
hMPV 16 Type A1, IA10-2003: 3.7x10? TCID
50
/mL
hMPV 20 Type A2 IA14-2003 G gene: 1.2x10
4
TCID
50
/mL
hMPV 5 Type B1, Peru3-2003: 3.8x10? TCID
50
/mL
hMPV 4 Type B2, Peru1-2002: 2.3x10? TCID
50
/mL