Attachment B - Salient Characteristics - JAK2.docx
DOCX document 17 KB Posted
- Solicitation number
- 36C26225Q1035
About this file
The document is a Salient Characteristics file for JAK2 Mutation Reagent and Consumables, detailing specific technical requirements for a VA laboratory testing kit. The VA seeks reagents and supplies compatible with their Applied Biosystem 7500 analyzer to detect JAK2 gene mutations, specifically the V617F mutation, using RT-PCR or High-Resolution Melt Analysis methods. Key technical specifications include detecting wild type versus mutated genes, compatibility with existing equipment, ability to process DNA from whole blood or bone marrow samples, and a minimum Limit of Detection of 0.061%.
The solicitation (36C26225Q1035) is for the VA Greater Los Angeles Healthcare System, requesting JAK2 Mutation Testing Reagents and Supplies for in-house patient testing. The specific product referenced is the Qiagen ipsogen MutaQuant JAK2 MutaQuant Kit, with an estimated annual quantity of 67 kits. Additional requirements include a one-year shelf life, DNA sample preparation specifications, and the ability to test JAK2 ex. 14 (V617F) gene mutation at a precise genomic location (c.1849G>T;p.V617F).
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| File | Type | Posted |
|---|---|---|
| 36C26225Q1035.docx | DOCX document | |
| Attachment A - Schedule.xlsx | XLSX spreadsheet |
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SALIENT CHARACTERISTICS
JAK2 Mutation Reagent and Consumables Reagents, supplies, and consumables must:
1. Detect the wild type (Negative) from Mutated (Positive) genes in a simplified workflow relative to alternative molecular testing technologies (RTPCR or NGS).
2. Reagents, supplies and consumables must physically fit and be compatible with the VA’s existing Applied Biosystem 7500 analyzer without alteration.
3. Reagents, supplies, and consumable must be compatible with all features and not void the warranty of VA’s existing Applied Biosystem 7500 analyzer.
4. Suitably for testing DNA extracted from whole blood or bone marrow samples using an RT-PCR-based method, or High-Resolution Melt (HRM) Analysis
5. DNA quantity should be determined by measuring the optical density (OD) of the sample at 260 nm.
6. The resultant DNA will need to be diluted to a concentration of 5 ng/µl in 1x TE buffer* at pH 8.0 and then stored at +4 to +8°C for 1 week or at –20°C if longer term storage is required.
7. The qPCR reaction is optimized for DNA samples containing 25 ng purified genomic DNA.
8. Be capable of Limit Of Detection (LOD) at a minimum of 0.061%
9. Shelf life of one year upon receipt by the laboratory.
10. Be capable of Genes Tested:
a. JAK2 ex. 14 (V617F)
b. Coverage: c.1849G>T;p.V617F
BRAND NAME OR EQUAL DESCRIPTION
| MFG |
| Brand |
| Description |
| Product Number |
| Est. Annual Qty |
| UoM |
| Qiagen |
| ipsogen MutaQuant |
| ipsogen JAK2 MutaQuant Kit (24 Reactions) |
| 673513 |
| 67 |
| Kit |
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