Diagnostic

HLA-B27 Detection Real Time PCR Kit

Over 95% of people that have been diagnosed with AS are HLA-B27 positive, although this ratio varies from population to population (only 50% of African American patients with AS possess HLA-B27, and it is close to 80% among AS patients from Mediterranean countries). HLA-B27 is the most relevant genetic marker of AS. In current clinical practice, HLA-B27 antigen is detected by flow cytometry or lymphocyte cytotoxicity tests. The kit is based on real time PCR to detect HLA-B27 qualitatively. CapitalBio HLA-B27 Detection Real Time PCR Kit utilizes a fluorescent dye with DNA double helix binding activity and generates fluorescent signal intensity readings of the PCR reaction system in a real time manner to detect HLA-B27 gene expression on the mRNA level qualitatively.

Key Features| Specifications| Applications| Reference| Certification| Ordering Information|

◆ High Specificity: The hot start feature of the Taq DNA polymerase reduces the non-specific amplification, thus improves the specificity.
◆ High Sensitivity: Super Green, A novel fluorescent dye, enhances the signal intensity, thus improves sensitivity compared to SYBR Green.
◆ High Accuracy: The integration of instrument automation and software analysis algorithm eliminates the uncertainty of human operations, thus improves the accuracy and reliability of the result analysis
◆ Flexible Sample Treatment: The sample collected can be stored at 4 or -20 centigrade instead of being tested on the same day
◆ Easy to Use: The one-tube-one-reaction format with prefilled aliquots only requires DNA templates before loading onto thermal cycler, thus reduces the labor.
 

 

Features
Parameters
Sensitivity
10 ng / reaction
Packing Size
48 tests / kit
Storage
in -20℃
Shelf Life
10 months
Platform
ABI7700, ABI7500 or CapitalBio RT-Cycler 136

The clinical trial results reveal the high correspondence of the CapitalBio assay with the flow cytometry test.
Beijing Hospital of China Ministry of Health
The statistics of 50 clinical cases: Positive correspondence 92.3%, negative correspondence 100%, overall correspondence 98%. χ²=0.53, P=0.817 (P>0.05), Kappa=0.947. There is no significant difference between the CapitalBio assay and the flow cytometry test.
 

Cases
Flow Cytometry
Total
Positive
Negative
CapitalBio Assay
Positive
12
0
12
Negative
1
37
38
Total
13
37
50

 

CapitalBio assay gave different result for only one case while the BD Anti-HLA-B27 kit gave a positive reading close to the threshold. The patient is a suspect of osteoarthritis.

Tongren Hospital, Beijing
The statistics of 50 clinical cases: Positive correspondence 100%, negative correspondence 100%, overall correspondence 100%. χ²=0.00, P=1 (P>0.05), Kappa=1. There is no difference between the CapitalBio assay and the flow cytometry test.

Cases
Flow Cytometry
Total
Positive
Negative
CapitalBio Assay
Positive
5
0
5
Negative
0
45
45
Total
5
45
50

 

Third Hospital of Peking University
The statistics of 50 clinical cases: Positive correspondence 100%, negative correspondence 100%, overall correspondence 100%. χ²=0.00, P=1 (P>0.05), Kappa=1. There is no difference between the CapitalBio assay and the flow cytometry test.
 

Cases
Flow Cytometry
Total
Positive
Negative
CapitalBio Assay
Positive
14
0
14
Negative
0
36
36
Total
14
36
50

 

In 1,049 clinical samples, the results obtained with the kit are 100% consistent with sequencing assays.

1. Brewerton DA, Hart FD, et al. Ankylosing spondylitis and HLA 27. The Lancet. 1973, 301: 904-907.
2. Schreuder G.M.Th, Hurley C.K. et al. The HLA Dictionary 2004: a summary of HLA-A, -B, -C, -DRB1/3/4/5 and -DQB1 alleles and their association with serologically defined HLA-A, -B, -C, -DR and -DQ antigens. Tissue Antigens. 2005, 65: 1–55.
3. Inman RD. Mechanisms of disease: infection and spondyloarthritis. Nature Clinical Practice Rheumatology. 2006, 2: 163-169.
 

 

HLA-B27核酸檢測試劑盒(熒光PCR染料法)注冊證

Registration Certificate for Medical Device No. 1103992, by Chinese State Food and Drug Administration, since December 8th 2011

 

Cat. No.
Product Name
Product Description
300051
HLA-B27 Detection Real Time PCR Kit
48 tests / kit, in one-tube-one-reaction format

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