New drug and othersubstance screening and testing requests from outside organisations are welcomed
Currently the analysis service which is offered to external organisations is flexible. There could be as few as one specimen and up to large batches of specimens. Analysis could be undertaken on existing methodologies, sourced methodologies or methods can be developed. The validation of methods can be undertaken to the extent required. Proficiency specimen investigation can form part of the analysis. Quantification studies can be undertaken.
Animal product analysis
The most active growth in contracts is in the field of animal product analysis. Recent contracts include multi-residue analysis of meat and related specimens from many animal species for banned substances such as growth promoters. The specialities being developed include the part per billion (ppb or mg/kg) trace analysis of compounds such as steroids, growth promoters, pesticides, antibacterials and antibiotics which include subclasses such as stilbenes, natural hormones, oestrogens, synthetic steroids, androgens, gestagen steroids, beta-lactams, aminoglycosides, tetracyclines, sulphonamides, quinolones, imidazoles, nitroimidazoles, benzimidazoles, macrocyclic lactones, anticoccidials, organophosphors, organochlorines, pyrethrins, pyrethroids, sedatives, mycotoxins, beta-agonists, carbamates, nitrofurans and thyreostats in specimen types such as meat/muscle, kidney, fat, thyroid, liver, urine and plasma/serum.
All of the above is in line with European Union legislation levels employing EU compliant validation and analysis protocols. These analyses are currently conducted for South Africa and other African countries. During 2007 the Laboratory was inspected by the European Commission Directorate-General Inspectorate.
Large analysis contracts conducted during 2006/2007 in a variety of matrices include:
Clinical analysis (Veterinary applications)
The experience of the Laboratory extracting and detecting drugs from plasma specimens at very low concentrations is extensive. Depending on the drug substance(s) or drug class(es), solid phase or liquid/liquid extraction is employed. Detection is most often by LC/MS/MS methodology employing MRM. This technique is excellent for drug quantification studies down to part per billion sensitivities, also making it ideal for clinical analysis studies such as drug bio-availability and drug product equivalence.
General aspects of contract analysis
- Specimen matrix
The matrix of the specimen must be discussed with the Laboratory. This will determine the extraction methodology to be employed. The Laboratory is well experienced in plasma, serum, meat, equine urine and pigeon faeces analysis.
- Extraction and analyte detection
The extraction and detection methodology will be determined by the type of analyte/range of analytes and the expected concentration/required screening sensitivity.
- Method development
In situations where suitable methodology is not in place in the Laboratory, these will be sourced and evaluated. Where required, new or improved methodology will be developed. For small analysis batches the cost of this will be separately specified while for large batches this will be incorporated in the analysis price.
- Method validation and Quality control specimens
An in-house validation is undertaken on all methodology employed and quality control specimens form part of analysis batches. Formal method validation and quality control can be undertaken to the requirement of the client.
- Reporting of results
An approximate completion time will be discussed on receipt of specimens. Analysis results will be reported in the format required such as electronic or hardcopy.
- Analysis of Positive specimens
Specimens containing analytes above the target concentration will be kept in secure storage. Additional work to be conducted on such specimens will be discussed with the client. Such work could take the format of a separate report for every analyte with highly specific data confirming the presence of the analyte.