Reference laboratory-info

Reference laboratory for clinical biochemistry at the Institute of Medical Biochemistry and Laboratory Diagnostics of the General Teaching Hospital and the 1st Faculty of Medicine, Charles University

Karlovo namesti 32, 121 11 Prague 2, phone 22496 6661

The Reference Laboratory was established at the Department of Clinical Biochemistry (OKB) of the University Hospital 2 in Prague by the Ministry of Health of the Czech Republic ref. LP / 4-278-18.2.1985 of 29.8.1985 (Journal of MZ 1986, vol. 8-12, p. 143). The Reference Laboratory is a testing laboratory accredited by the Czech Accreditation Institute o.p.s.

The Reference Laboratory is a testing laboratory accredited by the Czech Accreditation Institute o.p.s. according to ČSN EN ISO / IEC 17025: 2018 and as Testing Laboratory No. 1250.3.

RL is consistently involved in in vitro diagnostic medical devices testing. The most common are glucose systems - typically glucometers designed for self-monitoring of patients and determination of HbA1c by POCT systems.

Currently, RL has implemented the following accredited test methods:

1. Determination of plasma and serum glucose by spectrophotometry (according to SOP-ÚLBLD-RL-GLU1). Hexokinase-G-6P-dehydrogenase, bichromatically 340/380 nm, end-point, linked to SRM 917a, SRM 965a, linear range of measured concentrations is 2 to 33 mmol / l, Extended combined uncertainty with coverage factor k = 2 is 0.297 mmol / l, i.e. 5.95%.

2. Determination of glucose by system glucometer - measuring strip for verification of glucometer function (according to SOP-ÚLBLD-RL-GLU2) including the form for evaluation protocol. The glucose values determined by the mentioned methodology using a glucometer are statistically evaluated with the results determined by the comparative method (according to SOP-ÚLBLD-RL-GLU1).

3. Determination of HbA1c by POCT system to verify its function (according to SOP-ÚLBLD-RL-03) including a form for testing protocol. HbA1c values determined by the mentioned methodology using the POCT analyzer are statistically evaluated with the results determined by the comparative HPLC method performed in the Central Laboratory of ÚLBLD VFN on the Variant II TURBO BioRad analyzer (according to SOP-ÚLBLD-CL-HbA1c -01).

Test conditions are agreed upon order. The price is calculated considers the demands of the order, the number of repetitions, and the necessary ancillary expenses. The price calculation is always performed before acceptance of the order and any changes or additional testing are agreed upon in a written supplement to the order.

The testing procedure is described in the protocols of already tested POCT systems, which are published on the website https://ulbld.lf1.cuni.cz/referencni-lab

Praha ...1.2021 Prof. MUDr. Tomas Zima, DrSc.

Head of the Reference Laboratory

for Clinical Biochemistry at ÚLBLD VFN and 1. LF UK