DEPARTMENT: VIROLOGY
DIRECTOR: Bruce Patterson, M.D.
CHANGES FOR:
- Viral Reservoirs
- Viral Load, HIV Quantitative, PCR, Plasma
SPECIMEN REQUIREMENT CHANGES FOR VIRAL RESERVOIR TESTING
The specimens must be collected in a dedicated Yellow-top tube – Acid Citrate Dextrose (ACD), Solution A.
PPT tubes CAN NO LONGER BE USED for HIV Viral Load samples. We have made this change because BD Diagnostics, the tube manufacturer issued the following notification: “BD PPT tubes should not be used for HIV nucleic acid testing due to medically significant differences in results”.
Changes are in red text.
Viral Reservoirs, (Monocytes) |
Order Code: HVVRM |
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Specimen Type: |
Whole Blood |
Container Type: |
Dedicated Yellow-top tube Acid Citrate Dextrose Solution A (ACD) |
Required Volume: |
8.5 mL |
Minimum Volume (Pediatric): |
8.5 mL |
Special Handling: |
Must draw a dedicated tube. Tube cannot be shared with any other test except HVVRM. DO NOT CENTRIFUGE. Samples must be collected Monday - Wednesday only. Transport immediately (within 24 hours) to lab and keep at Room Temperature. |
CPT Codes: |
87797, 88184, 88185, 88291 |
| Report: |
Reference range =<2.4% |
Causes For Rejection: |
Excessive transport time greater than 48 hours. Incorrect transport/storage temperature. Incorrect tube type or mislabeled sample. White-top plasma preparation tube (PPT) has been discontinued and will be rejected. See note above. |
Viral Reservoirs, (T-Cell) |
Order Code: HVVRT |
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Specimen Type: |
Whole Blood |
Container Type: |
Dedicated Yellow-top tube Acid Citrate Dextrose Solution A (ACD) |
Required Volume: |
8.5 mL |
Minimum Volume (Pediatric): |
8.5 mL |
Special Handling: |
Must draw a dedicated tube. Tube cannot be shared with any other test except HVVRM. DO NOT CENTRIFUGE. Samples must be collected Monday - Wednesday only. Transport immediately (within 24 hours) to lab and keep at Room Temperature. |
CPT Codes: |
87797, 88184, 88185, 88291 |
| Report: |
Reference range =<1.1% |
Causes For Rejection: |
Excessive transport time greater than 48 hours. Incorrect transport/storage temperature. Incorrect tube type or mislabeled sample. White-top plasma preparation tube (PPT) has been discontinued and will be rejected. See note above. |
CHANGES FOR:
- HIV-I Quantitative, PCR, Plasma
- HIV Quantitative, PCR, Dilution Protocol (Discontinued Test)
METHODOLOGY CHANGE:
Effective April 1st, Viral Load has changed from a manual method to an automated platform for HIV-I Quantitative, PCR, Plasma. This new automated platform has increased linear range.
- FDA approved, Ampliprep has an increased linear range of 50-10,000,000 c/mL which is greater than the linear range of the manual method (COBAS Amplicor: 50-100,000 c/mL).
- Ampliprep automated method has greater throughput with 48 samples per day vs. 24 on the COBAS Amplicor:
- Automated extraction is more precise than a manual extraction.
- Ampliprep has specific sample requirement: Plasma separated from blood collected in a Lavender-top tube is required.
SPECIMEN REQUIRMENT CHANGE: Changes are in red text.
HIV-I Quantitative, PCR, Plasma |
Order Code: HIVQ2 |
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Synonyms: |
HIV -1 Viral Load, HIV RNA, HIV Ultrasensitive PCR |
Specimen Type: |
Plasma Note:2-3mLs EDTA plasma required. Test cannot be performed with less than 1mL of plasma. |
Container Type: |
Dedicated Lavender-top tube (EDTA) ONLY |
Required Volume: |
6.0 mL Whole blood |
Minimum Volume (Pediatric): |
3 mL (tube must be full) |
Special Handling: |
Centrifuge specimen within 6 hours of collection.
Remove plasma and transfer plasma to a screw-capped PCR aliquot tube. Please label transport tube: EDTA PLASMA. Transport Refrigerated.
If transport is greater than 3 days, Freeze and transport Frozen.
Note: Plasma separated from blood collected in a Lavender-top tube is required. |
Methodology: |
Real-time PCR |
TAT: |
5-7 days |
CPT Codes: |
87536 |
| Report: |
Linear Range of Assay- 50-10,000,000 copies/mL of plasma. (1.7 to 7.0 log 10) |
Causes For Rejection: |
Samples containing heparin; delay in transit; EDTA plasma is the only acceptable specimen, all others will be rejected. |
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