Enzyme Linked Immunosorbent Assay (ELISA)
The performance characteristics of the listed assay was validated by BioAgilytix Diagnostics. The US FDA has not approved or cleared this test. The results of this assay can be used for clinical diagnosis without FDA approval. BioAgilytix Diagnostics is a CLIA certified, CAP accredited laboratory for performing high complexity assays such as this one.
Specimen requirements | |
|---|---|
| Patient preparation | None Specified |
| Preferred specimen(s) | 1 mL platelet-free plasma collected in EDTA (lavender-top) tube |
| Minimum volume | 0.25 mL |
| Collection instructions | PSC Collections: Collect in EDTA (lavender-top) tube and immediately centrifuge to prepare platelet-poor plasma. Decant the plasma into another pour-over tube. Centrifuge a second time and pour over plasma. Freeze immediately. Client Collections: Collect in EDTA (lavender-top) tube. Centrifuge for 15 minutes at 1000 X g within 30 minutes of collection. Centrifuge plasma again at 3000 X g for 10 minutes for complete platelet removal. Freeze Immediately. For fixed speed centrifuges such as 645e: Collect in EDTA (lavender-top) tube. Centrifuge 3 times for 10 minutes at 1600 X g while decanting the plasma each time before the next spin within 30 minutes of collection. Freeze immediately. |
| Transport container | Transport tube |
| Transport temperature | Frozen |
| Specimen stability | Room temperature: Not established Refrigerated: 48 hours Frozen -20° C: 14 days Frozen -70° C: 30 days |
| Reject criteria | Hemolysis • Grossly lipemic • Specimens with particulate matter or microbial contamination • Specimens outside of listed stability • Samples submitted without two unique identifiers and date of collection |
Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.
*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.
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