Search Results

CellSave tubes are evacuated blood collection tubes that are designed to be used with standard phlebotomy supplies for venous blood collections. The tube contains 300µl of a solution that contains Na2EDTA and a cell preservative preservative preserves morphology and cell surface antigen expression of the epithelial cells and leukocytes. This tube may be used for monitoring of circulating epithelial cells (tumor cells) which may aid in the management of cancer patients. This tube may be used for monitoring CD3+/CD4+ T lymphocyte subsets which may aid in the management of patients with HIV/AIDS.

The CellSave™ tube is an evacuated closed glass tube for collecting, transporting and processing blood. The assembly consists of a rubber stopper, a glass tube and anticoagulant. The anticoagulant contains EDTA (disodium EDTA), polyethylene glycol and a preservative reagent.

Here's an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:

Acceptance Criteria and Device Performance

Device Name: The Immunicon CellSave™ Preservation Tube
Intended Use: Collection and preservation of circulating epithelial cells (tumor cells) and mature human T lymphocytes (CD3+) and helper/inducer (CD3+/CD4+) T lymphocyte subsets in whole blood, for enumeration and phenotyping.

Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • Circulating Epithelial Cell Preservation Study:
     • Test Set Size: 102 metastatic cancer patients providing 107 blood specimens. 70 specimens had sufficient volume for 24-hour and 96-hour testing, with 21 of these having ≥3 CTCs at both time points.
     • Data Provenance: Blood samples obtained from five geographically dispersed sites in the US. Retrospective or prospective is not explicitly stated but implies prospective collection for the study.
   • CD3/CD4 Immunophenotyping Study:
     • Test Set Size: 50 healthy volunteers and 12 patients with confirmed HIV.
     • Data Provenance: Not explicitly stated, but likely US given the context of other studies. Retrospective or prospective is not explicitly stated but implies prospective collection for the study.
   • Recovery and Interfering Substances Studies (Nonclinical):
     • Test Set Size: Blood from 5 normal donors for recovery; blood from 5 normal donors for interfering substances.
     • Data Provenance: Not explicitly stated, but likely originating from the US where Immunicon Corporation is based. These are in vitro spiking studies using donated blood.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

   • No external human experts were explicitly stated as establishing ground truth. The method relies on flow cytometry measurements (using FACSCalibur flow cytometer) for enumeration and phenotyping, which is an objective measurement rather than an expert interpretation. The "ground truth" for recovery studies was the known number of spiked cells or the initial count at 24 hours (for preservation studies).

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth relies on objective technical measurements (flow cytometry) rather than human interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This device is a blood collection tube intended for sample preservation, not an imaging or diagnostic algorithm that human readers would interpret. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not relevant to this device.

5. Standalone (Algorithm-Only) Performance:

   • Yes, the performance presented for recovery, interference, and preservation is standalone (i.e., the performance of the tube in maintaining cell viability and antigen expression for subsequent automated analysis). There is no "algorithm" in the traditional sense, but the studies assess the device's ability to preserve the sample for downstream laboratory processing and machine-based analysis.

6. Type of Ground Truth Used:

   • For Recovery Studies: The ground truth was the known number of spiked cells (SKBR-3 breast cancer cell line).
   • For Preservation Studies (Epithelial Cells): The ground truth was the initial count of circulating epithelial cells at 24 hours using flow cytometry, which was then compared to subsequent counts at 96 hours.
   • For Preservation Studies (T Lymphocyte Subsets): The ground truth was the initial counts of CD3/CD4 positive lymphocytes on Day 1 using flow cytometry, which was then compared to subsequent counts on Day 2 and Day 3.
   • For Interfering Substances Studies: The ground truth was the known number of spiked cells which was used to calculate percentage recovery.
   • In all cases, the primary measurement method for "ground truth" was flow cytometry.

7. Sample Size for the Training Set:

   • Not applicable. This device is a physical blood collection tube, not an AI/ML algorithm that requires a training set. The studies described are validation studies for the device's performance characteristics.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for this type of device.

Ask a specific question about this device