Intended Use
AllType FASTplex NGS HLA Typing products are for in vitro diagnostic use and professional use of HLA typing for HLA-A, -B, -C, -DRB1, -DBR3, -DRB4, -DRB5, -DQA1, -DQB1, -DPA1, and -DPB1 loci using next generation sequencing by synthesis, proton detection for transplant diagnostics.
Specimen Required
- Recipient: 1 / Purple / K2-EDTA / 2 mL
- Donor: 1 / Purple / K2-EDTA / 2 mL
Patient Preparation
- Sample collection –
- Specimen preparation
- DO NOT FREEZE blood or tissue samples intended for HLA testing or crossmatching, as freezing damages the cells.
- Storage/Transport Temperature
- Samples may be stored temporarily at refrigerated temperatures (4°C to 8°C) prior to dispatch. Ensure they are packaged to maintain this temperature during transit if required by local protocols.
- Unacceptable Conditions
- Remarks –
- Stability –
Methodology
The AllType FASTplex NGS 11 Loci product generates target-specific amplification products for multiple HLA genes in a single multiplex polymerase chain reaction (PCR). DNA sequencing data are obtained by processing the amplified product with a fragmentation library workflow to prepare a library that can be sequenced using Ion Chef Instrument and the Ion GeneStudio S5 Plus System. The AllType FASTplex NGS 11 Loci Kit has been designed and optimized to produce nearly equimolar quantity of each target to provide adequate sequence coverage. Resulting data are analysed using TypeStream Visual NGS Analysis Software to generate high resolution HLA allele assignments.
Sample received to report Turnaround time (TAT)
7 Working Days
Reference Interval
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Interpretive Data
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Resources
- Additional Technical Information
- Test Request Form
- List Item
Sample Reports
- Enhanced Report
- See Note