Analytes Ltd. is an experienced provider of a wide range of sample products to life science and pharmaceutical companies. We specialise in human serum, plasma and other matrices which are used in the development and manufacturing of diagnostic kits.
Our samples are freshly collected, resourced and processed according to international standards and are available in large volumes as well. Our ISO 9001:2008 certified methods and processes ensure that buyers maintain consistency in their test runs and measurements can be repeated.
We founded Analytes Ltd. in 2008, recognizing the need by diagnostic researchers and manufacturers for proper quality human samples in their development projects. Our professional clinical chemistry and immunoassay background together with our excellent cooperation with the best local hospitals and laboratories makes us well-positioned to fulfil routine and custom sample requests. Our laboratory professionals are available to process special and unique orders as well. Please feel free to contact us to learn more.
Our extensive range of quality samples includes
- human serum and different types of plasma (EDTA, Li-heparin, etc.) samples,
- human urine samples,
- matched urine, serum and plasma samples,
- patient samples with analyte concentration determined by market leader analysers on request,
- samples with or without clinical background information
- and custom orders.
Samples for manufacturing
- Large volume normal blood donor and patient samples for controls in kits and controls in manufacture. Our samples are non-spiked, pooled from real positive samples.
Samples for development
- Normal samples: Serum and plasma (Li-heparin, EDTA plasma, etc.) samples from normal healthy adults for the determination of a reference range. Normal urine samples and matched samples are also available.
- Clinical samples: For the development of new markers and clinical studies with detailed clinical background supplied. Clinical samples are essential for the verification of a new assay.
- Correlation samples: Serum, plasma and urine correlation samples for method comparison study. Concentration ranges are measured with market leader analysers. Volume: 3–6 mL.
- Immunoassay interference samples: To test immunoassay interference and side effects. Urine and serum interference samples are available.
- Linearity and dilution samples: Extra high and extra low concentration samples for dilution and linearity testing. Extra low concentration samples for limit of detection (LOD) and limit of quantification (LOQ) determination.
- Sample sets for FDA approval: Individual and pooled samples for
approval by the US Food and Drug Administration, including
- samples in high volume (3–6 mL) and wide concentration range,
- intra-assay, inter-assay and total-assay precision pools in wide concentration range,
- extra high and extra low concentration samples for dilution, addition and linearity testing and
- interference samples.
Collection methods and process
We are committed to collecting and processing all samples according to international guidelines and standards. We ensure safe handling, storage and transportation of samples. Orders are delivered in a timely manner and are ready for use. Our quality management system is compliant with the ISO 9001:2008 standard (certificate).
Analytes Ltd. can supply off-the-clot serum, serum from defibrinated plasma and plasma containing common anticoagulants. Off-the-clot serum is from blood that has been allowed to clot spontaneously after centrifugation with no anticoagulant added. Human serum is available from individual or pooled donors and can be differentiated by age, sex and a variety of disease states depending on your research focus. Plasma pools and bulk amounts of pools are also available from Analytes Ltd.
All blood samples are tested for infectious diseases (HBsAg, Hepatitis C Ab, HIV 1/2 Ab, Treponema Ab) according to Hungarian decree No. 3/2005. (II. 10.) EüM of the Minister of Health. Collection records indicate the date when the blood was collected and provide traceability.
Small volume blood samples collected from healthy blood donors (8 mL) are stored to clot before centrifugation for 2–4 hours at room temperature. After centrifugation the samples are refrigerated at 2–8 °C for 24–48 hours. Only sera that have been found negative for the infectious agents are transferred from the clot to one-litre polyethylene bottles, pooled and frozen at −20 °C until they are shipped to customers on dry ice.
One litre of genuine human serum pool is prepared from around 300 small individual serum samples. This method of preparation ensures that our serum pools are exactly the same as sera collected in clinical laboratories from patients. There are no added chemicals and no dilution.
By contrast, most human serum pools available worldwide are prepared from freshly frozen large volume plasma of blood donors. In most cases, the plasma is prepared from whole blood by mixing 450 mL of blood and 50 mL of citrate buffer. After separation of cells and plasma, the plasma is subject to special chemical treatment in order to transfer it into serum. This kind of artificial serum contains extra chemicals and is diluted. Controls prepared from artificial serum pools might behave differently compared to clinical patient serum samples. Therefore, genuine serum matrix should be preferred to artificial serum matrix whenever the control matrix must be as close to patient matrix as possible. Our genuine serum pools are collected freshly and contain no preservatives. Blood collection tubes for sera contain clot accelerator.
Samples are shipped on dry ice by courier mail.
Thank you for your interest in Analytes Ltd. To learn more about our products, please contact us:
Tel: +36 23 656 360
Sales and Enquiries
Karolyi utca 53