We offer you central laboratory services from our strategic partner – “Acinus” clinic. The clinic’s laboratory and its services may be of particular interest to your project since the laboratory has been engaged in a series of clinical trials and is fully suitable to be engaged as a Central Clinical Lab on a country and regional level. Its operational processes are highly optimized, correspond to ISO requirements, and are a subject to constant internal and external quality monitoring. The laboratory participates in a series of national and international quality assurance programs of comparative sample testing with outstanding results.
The department of laboratory diagnostics of the “Acinus” clinic was open in 1999. It first started as a small lab premises for express tests performed by nursing personnel. Now, it is a fully functional certified laboratory with capacities for general clinical tests as well as specialized hematological, biochemical, cytological and other types of tests. The laboratory carries out a wide range of immunological tests: from serological to enzyme immunoassays and PCRs.
The laboratory occupies two stories of a dedicated facility and is fully certified according to the national law. The laboratory is functionally structured and has several departments. Today the list of investigations includes more than 300 corresponding indicators. This list is primarily influenced by the current demand by referring physicians although technical possibilities of the lab equipment as well as skills of the personnel enable a wider range of tests.
The laboratory is fully equipped with a variety of technical devices and machinery. There are an automatic hematology analyzer Sysmex KX-21, binocular microscopes, urine analyzers CL-500 (NTІ, USA), biochemical analyzer Stat Fax, microplate photometer for immunoassay tests Stat Fax 2110, coagulometer Humaclot Duo plus, a 5‑channel system for real-time amplification Rotor - Gene Q, boxes for PCR UVC / TV-AR, boxes of antibacterial air environment for operator’s protection during work with pathogenic agents and microorganisms BAVp-01-”Laminar C”, a variety of centrifuges, dispensers, programmable thermostats, sterilizers and other auxiliary equipment.
The laboratory has highly qualified personnel: 5 laboratory doctors (one with PhD in biological sciences) have higher qualifications in the “clinical laboratory diagnostics” specialty; one biologist qualified for laboratory diagnostics, 5 certified doctor assistants with higher qualifications and several lab assistants.
All operations in the laboratory are standardized according to the requirements of local and international regulations. National regulations are in line with the requirements of ISO and State Standards of Ukraine (DSTU):
- DSTU ISO / TR 10013: 2003 “Guidelines for the development of quality management system documentation” (ISO / TR 10013: 2001, IDT);
- DSTU ISO 9000-2001 “Quality management systems. Main provisions and vocabulary” (ISO 9000: 2000, IDT);
- Rules for authorization and certification in the State metrological system, approved by Order 71 of the Ukrainian regulator (Derzhspozhivstandart) as of 29.03.2005.
The laboratory has the system of internal laboratory control. The system is supplied with standardized materials, samples and engaged with methods for statistical processing of the results of control tests. These control measurements enable quality assessment at different levels – from test results accuracy to technical equipment proper maintenance. The standardized materials used for quality control are from international manufactures, such as hematology control samples “CBC – 3d System” (United States), biochemical control samples “Biokont - C” (“Agat-Med”, Russia), “Lyonorm Gump” (Lachema, Czech Republic), and “Hemostat Control plasma Normal”.
The Laboratory takes part in the program of inter-laboratory comparisons of test results at the Ukrainian Reference Center for clinical laboratory diagnostics and metrology for the following programs:
1. Clinical biochemistry in clinical laboratory diagnostics (satisfactory results are 100%);
2. Haemostasis (satisfactory results are 100%);
3. Viral hepatitis and HIV (satisfactory results are 100%);
4. Immunochemistry (satisfactory results are 97%);
5. Hematology – automatic blood cells count (satisfactory results are 100%).
In addition, the laboratory is participating in the international program of inter-laboratory comparisons “RREVECAL” (External quality assessment program. Biochemistry program) performed by “Biosistem” company (Spain).
It’s been several years since the Laboratory is offering its centralized services for clinical trials in Ukraine. Some recent projects the Laboratory has been involved in include the following international research programs:
- AB 12003 (prostate cancer);
- DAB PED – BAC – 11-02 (bacteremia);
- DAB PED – OST – 11-03 (osteomyelitis);
- AB 12005 (pancreatic cancer);
APEX11-019 (VTE prophylaxis).