Qiagen/益生素JAK2 RGQ PCR试剂盒/673633
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商品介绍
ipsogen JAK2 RGQ PCR Kit
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For qualitative detection of the JAK2 V617F/G1849T mutation using real-time PCR
- Only FDA-cleared JAK2 PCR kit on the market
- Reliable detection of the JAK2 V617F/G1849T allele, a major diagnostic criterion for MPN according to the WHO guidelines (1)
- Highly sensitive and specific
- All-in-one, ready-to-use kit including QIAGEN master-mix and internal control
- Optimized for the Rotor-Gene Q MDx (US) instrument
- Automated solution using QIAsymphony SP and Rotor-Gene AssayManager v2.1 for analysis
The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The test is a real-time PCR assay performed on the QIAGEN Rotor-Gene Q MDx (US) instrument. The ipsogen JAK2 test is intended for use as an adjunct to the evaluation of suspected myeloproliferative neoplasms (MPNs), in conjunction with other clinicopathological factors. This test does not detect less common JAK2 mutations associated with MPNs, including mutations in exon 12, and is not intended for standalone diagnosis of MPNs.
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Cat No./ID:673633 ipsogen JAK2 RGQ PCR Kit (24) Log in to see pricing For 24 samples: V617F Positive Control, V617F Negative Control, 2 sets of plasmid standard dilutions JAK2 wild-type and JAK2 V617F, qPCR master-mix including Internal control, 2 Primers and Probe Mixes |
Cat No./ID:9024203-US Rotor-Gene AssayManager v2.1 Inquire Software for routine testing in combination withRotor-Gene Q MDxinstruments. IMPORTANT: Does not include license for use. License keymust be purchased separately. Visit the Download Page for download, installation and licensinginstructions. |
The ipsogen JAK2 RGQ PCR Kit is intended for use in diagnostic procedures.
For prescription use only.
References:
- Arber, D.A. et al. (2016) The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood 127, 2391.
Product Details
Performance
The clinical performance of the ipsogen JAK2 assay in the diagnosis of PV was evaluated in a multicenter, international, prospective, interventional study enrolling over 200 patients. Using the ipsogen JAK2 RGQ PCR Kit for polycythemia vera (PV) diagnosis, the sensitivity was 94.6% and the specificity was 98.1%.* This demonstrates that the ipsogen JAK2 RGQ PCR Kit enables detection of PV in the vast majority of subjects with the disease, and helps rule out the disease in the vast majority of subjects without PV. The concordance of JAK2 V617F mutation detection with bi-directional sequencing (BDS) and NGS was also assessed on gDNA samples extracted from a total of 473 specimen: 276 with suspected PV, 98 with essential thrombocythemia (ET) and 99 with primary myelofibrosis (PMF). The ipsogen JAK2 RGQ PCR assay was 100% accurate for the detection of JAK2 V617F allele in specimen from subjects with JAK2 V617F levels ≥1%.
* The calculation of sensitivity and specificity includes 4 cases with inconclusive bone marrow histologies as well as 2 discordant cases. For the discordant cases, the investigator used clinical discretion deviating from the WHO diagnostic algorithm for the diagnosis of PV. For further details, refer to the ‘clinical performance’ section of the ipsogen JAK2 kit handbook.
Principle
The ipsogen JAK2 RGQ PCR Kit uses TaqMan polymerase chain reaction (PCR) probes and ARMS (Amplification Refractory Mutation System) technology on the Rotor-Gene Q MDx (US) instrument for sensitive and specific JAK2 V617F mutation analysis. Results are expressed as mutation detection status based on a ≥ 1% mutant allele frequency cut-off. The percent mutant allele burden of JAK2 V617F in total JAK2 wildtype is reported by means of corresponding quantitation curves. Performance is ensured by wildtype and mutant positive and negative controls for every run, and by an internal control in a separate fluorescence channel for every sample.
Procedure
The ipsogen JAK2 RGQ PCR Kit provides an automated workflow from blood sample to result in less than 4 hours with easy-to-use protocols validated on the QIAsymphony SP and Rotor-Gene Q MDx (US) instruments. Ready-to-use solutions and a QIAGEN PCR master mix are included in the kit for rapid qualitative analysis of the JAK2 V617F/ G1849T mutation for up to 24 samples per run. Finally, the Rotor-Gene AssayManager software simplifies data analysis and management, and maximizes process safety for efficient and timely result reporting.
Applications
JAK2 V617F is a major diagnostic criterion for myeloproliferative neoplasms (MPNs) according to the WHO guidelines (1).
The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The test is a real-time PCR assay performed on the QIAGEN Rotor-Gene Q MDx (US) instrument. The ipsogen JAK2 test is intended for use as an adjunct to the evaluation of suspected myeloproliferative neoplasms (MPNs), in conjunction with other clinicopathological factors. This test does not detect less common JAK2 mutations associated with MPNs, including mutations in exon 12, and is not intended for standalone diagnosis of MPNs.
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品牌介绍
QIAGEN是一家专业化致力于生物分子样品制备解决方案的跨国经营企业，总部位于德国。1984年，QIAGEN在德国成立，1996年在美国纽约纳斯达克上市。QIAGEN拥有超过1000项专利和认可证明，在18个国家设立了分公司，代理商服务国超过40个，在全球有超过400000的用户。QIAGEN提供的产品超过500类，包括各种试剂，耗材和自动化纯化工作站。这些产品用于样品采集，稳定，核酸或蛋白的分离，纯化和检测中，不仅广泛的应用于科研领域的各个方面，在生物技术，制药，法医研究，食品安全检测，畜牧业和分子诊断领域也得到了广泛的应用。QIAGEN产品的卓越品质和在应用中的出色表现使得其成为样品处理中标准的代名词。
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