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Chromosomal Aberration

Chromosomal Aberration

The Chromosome Aberration test is used to screen medical devices/materials to determine if they cause structural chromosome aberrations in Chinese Hamster Ovary (CHO) cells. The test is performed on devices/materials that have permanent patient contact, prolonged patient contact or blood contact.
Chromosomal Aberration test complies with OECD and ISO guidelines as one of the three levels of in vitro tests for genotoxicity.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

  • ANSI/AAMI/ISO 10993-3
  • OECD 473
  • ANSI/AAMI/ISO 10993-12

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
GTX220 Genotoxicity: Chromosomal Aberration, CHO cells, 2 extracts, OECD 473 (solid) 56 Add
GTX221 Genotoxicity (GLP): Chromosomal Aberration, CHO cells, 2 extracts, OECD 473 (solid) 56 Add
GTX220 - Genotoxicity: Chromosomal Aberration, CHO cells, 2 extracts, OECD 473 (solid)
56 days
GTX221 - Genotoxicity (GLP): Chromosomal Aberration, CHO cells, 2 extracts, OECD 473 (solid)
56 days

Sample Specifications

GTX220: 4 complete devices, each device must be at least 120 cm2 or 4 grams
GTX221: 4 complete devices, each device must be at least 120 cm2 or 4 grams

Study Outline

The Chromosome Aberration assay is performed by exposing CHO cells to the test article extract. A blank of extraction media is included in the assay as the negative control.
 
CHO cells are seeded into 75 cm2 cell culture flasks and incubated with cell culture media + 10% serum until 40 – 60% confluent.
 
The CHO cells are exposed to the test article extract in the presence and absence of a metabolic activation system. The metabolic activation system is a mixture of S9 homogenate, isocitrate and NADP. The positive controls used are Cyclophosphamide with metabolic activation and Mitomycin C without metabolic activation.
 
Prior to cell harvest, the cells are examined for cytotoxicity. The flasks are scored as to the degree of discernable morphological cytotoxicity on a relative scale of 0 – 4 in accordance with AAMI/ANSI/ISO 10993-5 and USP <87>. The results from the three flasks are averaged to give a final cytotoxicity score.

At the end of the exposure and expression periods, the cells are arrested in metaphase with colcemid. The cells are then removed from the flasks and treated with a hypotonic solution and fixative. The cells are dropped onto microscope slides. The chromosomes are stained with Giemsa stain and coverslipped with Permount®. The cells are then examined microscopically for chromosome aberrations.