Test Bulletin

Dear Healthcare Provider,

The information contained here may be very important to your practice. Please take a moment to review this document.

C.  difficile TEST ALGORITHM CORRECTION
January’s C. difficile Algorithm bulletin incorrectly listed the rapid EIA assay CPT codes as 81455 and 88387. The correct CPT codes are 87324 and 87449.

NT proBNP ASSAY BACK ORDER: FEBRUARY 26, 2019
Due to a manufacturing back order, the go-live date for the NT proBNP assay offered at the Central Laboratory will be postponed until February 26, 2019. Please follow current collection manual instructions for specimen type until February 26.

Test Summary – Utilization Guidelines

Solid Tumor Panel
Next Generation Sequencing

February 25, 2019

Clinical Use
The Oncomine Focus Assay detects targeted somatic mutations that are useful for prognosis and/or treatment of individuals with solid tumors.

Clinical Background
The Oncomine Focus Assay is a DNA- and RNA-based next generation sequencing test targeting 52 genes to detect single nucleotide variations and insertion/deletion variations (35 genes), copy number variations (19 genes) and gene fusions (23 genes) relevant in the pathobiology of malignancy. Solid tumor molecular testing is indicated for guiding the use of FDA- approved targeted therapies, especially in advanced and treatment-refractory malignancy. Identifying specific variations may help determine prognosis and may be associated with response or resistance to specific therapies. The molecular alterations detected may also have relevance regarding enrollment in clinical trials and emerging clinical actions.

Specimen Requirements:
Specimen: Formalin-fixed paraffin-embedded tissue (FFPET)

  • Resection or surgical biopsies: 8 unstained 5-micron slides (Min: 5 slides)
  • Core needle biopsy: 15 unstained 5-micron slides (Min: 10 slides)

Stability: Blocks: room temperature (15-30°C) indefinitely; 5-micron sections mounted on slides may be stored at 15-30°C for up to 6 months.
Cause for Rejection: Frozen; Less than 10% tumor cells; Specimens that have been decalcified
Method: Next Generation Sequencing
Detects single and multiple nucleotide variants, insertions and deletions, copy number variants, and fusions.

Turnaround Time: 7-14 days
CPT code: 81455; 88387
SOFT code: NGSST

*CPT codes provided are for informational purposes only. Questions regarding coding should be directed to the payor.

HIV1 RNA, Quantitative Viral Load
Specimen Update

Pearl Top Tubes – no longer accepted

February 2019

Studies have shown that viral loads close to the lower limit of the reportable range may show falsely elevated results when collected in Plasma Preparation Tubes (Pearl Top PPTs) and quantified on the Roche COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 v2.0 Assay. This is due to proviral DNA from contaminating lymphocytes that may not be completely removed from the plasma portion of the PPTs.

Specimen Requirements:
Specimen: EDTA Plasma. Collect 2 Lavender (EDTA) Tubes. Samples must be separated from cells within 24 hours by centrifugation for 20 minutes at 800-1600g (3000 rpm).

Do not send Pearl Top Tubes (PPTs). These may lead to falsely increased values.

Stability: Plasma samples – 6 days at 2-8°C. Whole blood – 24 hours.
Volume: Minimum 1.5 mL / Optimum 3 mL

Cause for Rejection:

  • Whole blood samples that have not been separated within 24 hours of collection
  • Hemolyzed Samples
  • Frozen Primary (parent) tubes

Method: PCR (Polymerase Chain Reaction)
CPT code: 87536