商品编号


M925



品牌


Quidel



公司


Quidel,inc.



公司分类





Size

96 tests

商品信息

Description:
Solana Respiratory Viral Panel Kit1 Solana Influenza A+B Assay test kit (48 tests)1 Solana HSV + hMPV Assay test kit (48 tests)
Features & Benefits:


Solana Respiratory Viral Panel









The Solana Respiratory Viral Panel (RVP) combines two Solana respiratory assays,
Solana Influenza A+B
and
Solana RSV + hMPV
, to create a focused respiratory viral panel to detect and differentiate all four respiratory viruses (influenza A, influenza B, respiratory syncytial virus and human metapneumovirus) from a single patient sample. Test up to 6 patients at a time in just 45 minutes using Solana’s high-volume throughput.

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

The process buffer is universal between both kits, which allows testing for all four conditions using a single patient sample. Testing is done using two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to RSV, hMPV, influenza A and/or influenza B 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. Manage de-identified data, in near real time for improved operational efficiencies, using the Power of Virena
?
, which is integrated directly into Solana.










Feature
Benefit



Universal buffer solution
Test for all four viruses using a single patient sample



Small, easy-to-use instrument
Great for smaller labs. Saves space at 9.4" x 9.4" x 5.9". Eliminates the need for dedicated molecular space and costly capital equipment.



Power of Virena
Manage data and resources for a single site, or multiple sites from any web-enabled device. Report and monitor disease prevalence in your community.



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



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


Note: Influenza A+B specimens collected in Copan eSwab transport media are stable at 2° C to 8°C for up to 48 hours



Time to results
Approximately 45 minutes



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



Controls 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%)


Influenza A: 97.2% (95% CI 95.0% to 98.4%)
Influenza B: 100.0% (95% CI 95.4% to 100%)


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


Influenza A: 96.7% (95% CI 95.4% to 97.7%)
Influenza B: 98.9% (95% CI 98.2% to 99.4%)


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


LOD (Influenza A)
A/Taiwan/42/06: 7.5x10
2
TCID
50
/mL
A/California/07/2009: 4.7x10
2
TCID
50
/mL
A/Texas/50/2012: 6.3x10
0
TCID
50
/mL


LOD (Influenza B)
B/Brisbane/60/08: 8.5x10
1
TCID
50
/mL
B/Massachusetts/2/2012: 3.3x10
1
TCID
50
/mL