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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.
◆ 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.
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 |