商品编号


M103



品牌


Quidel



公司


Quidel,inc.



公司分类


Lyra



Size

96 tests

商品信息

Description:
Assay Kit
Features & Benefits:







The Lyra Direct Strep Assay is a Real-Time PCR
in vitro
diagnostic test for the rapid and qualitative detection and differentiation of
Group A β-hemolytic Streptococcus (Streptococcus pyogenes)
and
pyogenic Group C and G β-hemolytic Streptococcus
(
Streptococcus dysgalactiae, Streptococcus equi, Streptococcus canis
) nucleic acids isolated from throat swab specimens obtained from symptomatic patients.

Streptococcal pharyngitis, or "strep throat,"?is a common bacterial infection found in childhood. Group A Streptococci are respons
IBL
e for the majority of Streptococcal pharyngitis cases although other species, such as
S. dysgalatiae
,
S. equi
and
S. canis
(pyogenic Group C and G β-hemolytic Streptococcus) may also cause disease.

Tr
ADI
tionally,
Streptococci
have been classified by the production of hemolysis on blood agar and by the use of Lancefield group antigens; however, culture hemolysis can be imprecise due to number of factors (operator experience, incubation conditions of the culture, types of hemolysin produced by the organism, etc.) and the Lancefield group antigen does not correlate with the species. Additionally, culture results may take 2 to 3 days such that physicians treat patients presumptively while awaiting culture results or withhold antibiotic therapy until the causative organism is confirmed with culture. Fortunately, molecular taxonomic studies have improved classification and time to results.

The Lyra Direct Strep multiplex real-time PCR reaction is carried out under optimized conditions in a single tube generating amplicons for Group A, C & G and the Process Control (PRC). It provides?test results in less than 70 minutes for the identification of Group A and Group C or?G
(
the assay does not differentiate between pyogenic Groups C and G β-hemolytic Streptococcus)
. Specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of the group A
Streptococci
, pyogenic group C and G
?Streptococci
and the PRC allow for a highly specific, highly sensitive assay.

The Lyra Direct Strep Assay has one-step reagent set-up and a three-step sample prep and is available for use on the
Applied Biosystems
? 7500 series of instruments.










Feature
Benefit



One-step reagent set-up
Rehydration solution is simply added to the lyophilized Master Mix



Speed
Results in less than 70?minutes after extraction



Easy training
Simplified and uniform workflow with standard pipetting volumes



Refrigerated storage
No freezer needed. 2°C to 8°C storage



Long shelf life
2 years from date of manufacture



Room temperature set up
No ice or cooling block required



Flex
IBL
e 96-test format
Kit includes vials of 12x8 Master Mix, Rehydration Solution and liquid Process Controls












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Nasal swab, Nasopharyngeal swab



Time to results
Less than 75 minutes after extraction



Reagent storage conditions
2°C to 8°C



Controls storage conditions
2°C to 8°C



Sensitivity*
RSV: 98.6%



Specificity*
RSV: 96.8%



LOD
RSV A: 6.29E-01; RSV B: 7.5E-01; hMPV-A1: 1.7E+01; hMPV-A2: 2.91E+00; hMPV-B1: 1.05E+00; hMPV-B2: 2.25E+00



Purified nucleic acid volume needed to test
5 ?L



Shelf life
24 months








*Refer to Package Insert for additional performance claims.