Intended Use
To detect the presence of HLA antibodies using Luminex xMAP technology.
Specimen Required
Recipient: 1 / Purple / K2-EDTA / 2 mL
Patient Preparation
- Sample collection
- Recipient: Fasting Blood Samples preferred
- 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:
- Sample older than 24 hours after collection is not suitable.
- Lipemic samples will interfere with the reading of results.
- Haemolysed Samples
- Remarks –
- Stability –
Methodology
The test is performed using the One Lambda LABScreenTM Mixed Class I & II assays for the detection of HLA Class I, HLA Class II, and MICA antibodies in the patient’s serum/plasma. The principle of the assay involves incubating the test serum with LABScreen beads which are coated with HLA Class I/ Class II and MICA antigens. Any HLA antibodies present in the test serum bind to the antigens on the beads and are then labeled with R-Phycoerythrin (PE)-conjugated goat anti-human IgG. The Luminex LabScan 100, LABScan 3D, or FLEXMAP 3D flow analyzer is used for analysis. This instrument simultaneously detects the fluorescent emission of PE and a dye signature from each bead, allowing for near real-time data acquisition. The positive/negative cut-off is determined by selecting an NBG ratio that gives a significant shift over the background fluorescent value, validated using negative control serum and reference allosera with defined HLA antibody specificity. For LABScreen Mixed, if any one bead in the mixed assay is positive, then the result should be assigned as positive. The LABScreenTM Mixed assay specifically detects the presence of antibodies to Class I and/or Class II HLA antigens and MICA antigens.
Sample received to report Turnaround time (TAT)
5 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 report
