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EasySep Human Bone Marrow CD138 Positive Selection Kit is an in vitro diagnostic device intended to enrich CD138+ cells from bone marrow collected from patients diagnosed with multiple myeloma. The CD138+ cells are enriched by immunomagnetic positive selection for use in validated downstream assays. The end-user is responsible for validation of this kit for use with the assay. For in vitro diagnostic use by laboratory professionals.

The EasySep CD138 Human Bone Marrow CD138 Positive Selection Kit contains reagents to enrich CD138 positive (CD138+) human bone marrow cells. The kit contains reagents for up to 60 mL of bone marrow purifications. The kit contents are listed in Table 1. Materials required but not provided are shown in Table 2.

Acceptance Criteria and Device Performance for EasySep Human Bone Marrow CD138 Positive Selection Kit

This document summarizes the acceptance criteria and a detailed account of the studies conducted to demonstrate the EasySep Human Bone Marrow CD138 Positive Selection Kit meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

• Med (3-15%): 4.5% (2.2 - 7.0%)
• Low ( 90% of enriched CD138+ purity from control samples (without excess heparin).**
  Statistical difference: Not statistically different from control specimens (for low frequency specimens). | Three clinical specimens (initial 0.4%, 5.0%, 31.3%):
• Specimen #1: 91.0% of control
• Specimen #2: 103% of control
• Specimen #3: 98.0% of control
  **Three low frequency clinical specimens (initial 73h).
  Specimen #2 (initial 0.5%): FISH results consistent with baseline and 44-54h. More variable (~73h) due to insufficient cells.
  Specimen #3 (initial 0.4%): FISH disposition for three probes analyzed consistent across time points (baseline -> ~73h).
  Overall, FISH disposition was consistent between baseline and ~73h for all three specimens when initial CD138 frequencies were above the putative LLoD for the flow assay. |
  | Kit Stability (Shelf-Life and In-Use) | Ability to enrich CD138+ cells to a purity of >95% and >70% recovery. | Met all acceptance criteria at long-term and in-use storage (5°C ± 3°C) for up to 7 months, and accelerated storage (25°C ± 2°C/60% ± 5% RH) for up to 7 days. Supports a 6-month shelf life at 5°C ± 3°C. |
  | Kit Stability (Shipping) | CD138+ cell purity had to be >95% with at least 70% of cells recovered after exposure to summer and winter temperature profiles for 48 hours. | All acceptance criteria were met at the long-term storage condition of 5°C ± 3°C for up to 7 months, demonstrating product performance unaffected by transport stress. Supports a 6-month shelf-life following transport stress. |
  | Limit of Detection (Contrived Samples) | Lowest initial CD138+ frequency that gives consistent abnormal FISH results in a contrived specimen after CD138+ cell enrichment. | Consistently achieved abnormal t(11;14) disposition in FISH analysis for contrived specimens targeting as low as 0.08% initial CD138+ frequency. Final LoD set at 0.05% CD138+ (limit of detection of the flow cytometer). |
  | Limit of Detection (Clinical Samples) | Overall enriched purity CV ≤ 35%.
  Enriched samples' FISH disposition same as undiluted clinical specimen's FISH disposition for all probes. | Specimen enriched from 0.05% to 4.1% - 7.4%. Overall enriched purity CV was 19.7% (meeting ≤35%). All enriched samples had FISH disposition identical to the undiluted clinical specimen (100% abnormal for Chromosome 13q deletion and TP53). |
  | Clinical Study (FISH) | Increased percentage of abnormal nuclei in enriched samples compared to unenriched samples.
  Successful enrichment of a range of bone marrow CD138+ cells (low, intermediate, and high) with viable cells for FISH. | CD138 purity increased from 12.9% ± 15.9% (pre-enrichment) to 79.6% ± 19.9% (post-enrichment). Fold enrichment > 1 for all specimens with CD138 frequencies

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