Ames Test
The Ames Test is the gold-standard in vitro genetic toxicity screening assay fully compliant with OECD TG 471 guidelines, specifically designed to evaluate the mutagenic potential of lead compounds in early drug development. The core detection principle relies on histidine auxotrophic tester strains of Salmonella typhimurium, including TA98, TA100, TA1535, TA1537, and the Escherichia coli WP2 uvrA strain. These bacterial strains carry inherent gene defects that completely block endogenous histidine synthesis, meaning they cannot grow and form visible colonies on minimal culture media without exogenous histidine supplementation. When lead compound molecules possess mutagenic activity, they will induce targeted reverse mutation in the bacterial genome, repairing the defective functional genes related to histidine metabolism. To simulate complex in vivo human metabolic environments and avoid false-negative detection of pro-mutagens that require metabolic activation, the assay is performed under two parallel conditions: with and without rat liver S9 metabolic activation system. Mutagenic risk is accurately judged by statistically comparing the number of revertant colonies in the lead compound experimental groups with spontaneous colonies in the negative solvent control group, providing reliable genetic toxicity safety data for lead compound early screening.
Standard Experimental Workflow
- Dose Grouping and Aseptic Sample Batching: Scientific and reasonable concentration gradient groups are set for lead compounds according to solubility and preliminary cytotoxicity characteristics. Meanwhile, negative solvent blank control groups and standard positive mutagen control groups are configured synchronously. Under strict ultra-clean isolation conditions, lead compound solution, qualified bacterial suspension, S9 metabolic activation mixture, and low-melting soft agar are fully and evenly mixed in proportion.
- Plate Pouring and Constant-Temperature Dark Cultivation: The uniformly mixed experimental samples are quickly and evenly poured onto minimal nutritional agar plates without histidine additives. All sealed plates are placed in a calibrated constant-temperature environment for long-term dark static incubation to simulate stable bacterial growth and natural gene reverse mutation induction conditions.
- Automatic Counting, Data Statistics and Formal Report Issuance: After the incubation cycle is completed, the revertant colonies on all experimental plates are counted with high precision. Professional laboratory personnel conduct unified statistical comparison and difference analysis on colony data of each group, scientifically judge the mutagenic positive and negative results of lead compounds, and finally issue a complete GLP-compliant original test report.
PharmaAnalytica's Technology Platform
MOST-L Laboratory Series Steam Sterilizer
The MOST-L Laboratory Series Steam Sterilizers are mainly applied by laboratories in universities, pharmaceutical factories, inspection departments and disease control & prevention centers for sterilization of labware, culture medium, unsealed liquid or preparation and materials that may contact blood or body fluid in scientific research or medical care units.
SW-CJ-1F Vertical Laminar Flow Clean Bench
SW-CJ-1Fprovides a Class 100 ultra-clean, dust-free, and bacteria-free closed operating environment for all manual experimental operations. The equipment effectively isolates indoor dust, airborne microorganisms, and cross-contamination sources, fully protecting the biological activity of tester bacterial strains. It ensures all sample preparation, strain transfer, reagent addition, and plate pouring operations are completed under stable aseptic conditions.
THZ-82A Constant Temperature Oscillating Shaker
THZ-82A is specially used for large-scale expansion cultivation of standard Ames bacterial strains. It precisely maintains a constant temperature of 37 °C and stable adjustable oscillation speed between 150 rpm and 180 rpm, simulating the optimal physiological growth environment for bacteria. It rapidly produces high-purity, high-activity bacterial suspensions with stable concentration, ensuring consistent strain activity across all test batches.
HT230R High-Speed Benchtop Refrigerated Centrifuge
HT230R is specially configured for the critical preparation of rat liver S9 metabolic activation fractions in Ames testing. It supports precise low-temperature constant‑speed operation, maintaining a stable 4 °C cold environment with high powerful relative centrifugal force, rapidly and efficiently separating high-purity, high-activity liver microsomal supernatant. Equipped with multiple safety protection and intelligent temperature control functions, the instrument effectively protects the biological activity of metabolic enzymes in S9 mixture.
DNP Constant Temperature Incubator
DNP is dedicated to the long-term dark static incubation of all prepared Ames test agar plates. The incubator maintains a highly stable constant temperature of 37 °C with extremely small temperature fluctuation range. It ensures synchronous, consistent growth of bacterial colonies and stable reverse mutation induction efficiency on all parallel plates, preventing data deviation caused by uneven temperature distribution.
icount 60 Fully Automatic Colony Counter
Equipped with a high-resolution industrial imaging system and intelligent microbial image recognition algorithm, icount 60 automatically captures plate images, identifies subtle revertant colonies, and completes batch counting within seconds without manual auxiliary observation. The built-in anti-interference light-shielding structure eliminates ambient light interference, ensuring stable recognition accuracy even for low-density and tiny mutagen-induced colonies.
PharmaAnalytica's Ames Test Service
Professional & Experienced Technical Team
Our in-house technical team consists of senior laboratory analysts with rich experience in genetic toxicity assessment and Ames assay operations. All personnel are fully trained in GLP and OECD guidelines, proficient in strain quality control, S9 activity verification, and abnormal data troubleshooting to ensure stable experimental execution.
High Data Accuracy & Strict Quality Control
Adopting fully calibrated instruments and unified standard SOPs, we strictly control background pollution, strain activity, incubation temperature and counting errors. All raw data is automatically recorded and traceable, ensuring high reproducibility and low deviation of mutagenicity test results for lead compounds.
Full-Cycle Compliant & One-Stop Service Support
The whole testing process fully complies with OECD TG 471 and GLP laboratory management standards. We provide one-stop services from sample receiving, strain testing, full-process experiment operation to final compliant report issuance, supporting direct use for preclinical project declaration and technical review.
Cost-Effective & Fast High-Throughput Delivery
Relying on stable and high-performance instrument clusters, we effectively reduce comprehensive testing costs compared with imported equipment solutions. The automated experimental workflow supports batch high-throughput detection, shortening the overall testing cycle and accelerating early lead compound safety screening progress.
Backed by STEMart's comprehensive analytical strength and full set of validated high-performance instruments, our staged whole-process Ames testing features low comprehensive cost, short experimental cycle and high data credibility. The professional technical team controls key quality nodes of each detection link in real time, supports high-throughput batch testing of multiple lead compound samples, and provides one-stop technical problem-solving support. In conclusion, PharmaAnalytica efficiently and accurately identifies the genetic toxicity risks of lead compounds at the early research stage, accelerates the safe structural optimization of lead candidates, and provides solid, standardized and reliable safety basic data for the seamless follow-up of preclinical pharmacology and toxicology research of new drugs.
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