Table 2 Biomarkers and their analysers, analytical methods and quality criteria
Biomarkers in alphabetic order | Analyser model | Manufacturer | Test method | Frequency of quality controls (3 shifts per day.) | Acceptable Root Mean Standard Deviation as defined by Rili-BAEK | Range of interest as defined by Rili-BAEK | Unit |
|---|---|---|---|---|---|---|---|
Alpha-HBDH | AU 680 | Beckman Coulter Inc., Brea, United States | Kinetic (decreasing) UV-Test at 37 °C | Twice per 8 h-shift plus after every 50 specimen. | not defined by Rili-BAEK | not defined by Rili-BAEK | U/l |
Antithrombin III | STA-R Evolution | Diagnostica Stago S.A.S., Asnieres sur Seine, France | Colorimetric Assay (ELISA) of Antithrombin III Activity | 4 times per 8 h-shift. | not defined by Rili-BAEK | not defined by Rili-BAEK | U/l |
aPTT | STA-R Evolution | Diagnostica Stago S.A.S., Asnieres sur Seine, France | Time to clotting after recalcification of plasma in the presence of cephalin (platelet substitute) and a factor XII activator (poly-phenolic component) | 4 times per 8 h-shift. | 10,5% | 20–120 | sec. |
Calcium (ionized) | ABL 800Flex | Radiometer Medical ApS, Brønshøj, Denmark | Potentiometric method | Once per 8 h-shift. | 14% | 0,2–≤ 1 | mmol/l |
7,5% | >1–2,5 | ||||||
Chloride | ABL 800Flex | Radiometer Medical ApS, Brønshøj, Denmark | Potentiometric method | Once per 8 h-shift. | 4,5% | 70–150 | mmol/l |
Creatin Kinase (CK) | AU 680 | Beckman Coulter Inc., Brea, United States | International Federation of Clinical Chemistry and Laboratory Medicine Method | Twice per 8 h-shift plus after every 50 specimen. | 11% | 50–1000 | U/l |
Creatinine | AU 680 | Beckman Coulter Inc., Brea, United States | Kinetic colorimetric Jaffe reaction | Twice per 8 h-shift plus after every 50 specimen. | 11,5% | 0,5–10 | mg/dl |
Fibrinogen | STA-R Evolution | Diagnostica Stago S.A.S., Asnieres sur Seine, France | Clauss clotting assay | 4 times per 8 h-shift. | not defined by Rili-BAEK | not defined by Rili-BAEK | mg/dl |
Free Haemoglobin | Cobas Integra 400 | Hoffmann- La Roche AG, Basel, Switzerland | Colorimetric Test | 4 times per 8 h-shift. | 20% | not defined by Rili-BAEK | mg/l |
Glutamic Oxaloacetic Transaminase (GOT/AST) | AU 680 | Beckman Coulter Inc., Brea, United States | International Federation of Clinical Chemistry and Laboratory Medicine - Method | Twice per 8 h-shift plus after every 50 specimen. | 11,5% | 20–400 | U/l |
Haemoglobin | XE5000 | Sysmex Corporation KK, Kobe, Japan | SLS (sodium lauryl sulphate) haemoglobin method | Once per 8 h-shift. | 4% | 2–20 | g/dl |
INR | STA-R Evolution | Diagnostica Stago S.A.S., Asnieres sur Seine, France | Time to clotting after addition of Calcium-rich thromboplastine (Neoplastine CI plus) | 4 times per 8 h-shift. | not defined by Rili-BAEK | not defined by Rili-BAEK | n.n. |
Leukocytes | XE5000 | Sysmex Corporation KK, Kobe, Japan | Flow cytometry with dynamic focusing | Once per 8 h-shift. | 6,5% | 2–30 | 109/l |
Myoglobin | AU 5800 | Beckman Coulter Inc., Brea, United States | electrochemiluminescence-immunoassay | Twice per 8-h shift | not defined by Rili-BAEK | not defined by Rili-BAEK | μg/l |
Potassium | ABL 800Flex | Radiometer Medical ApS, Brønshøj, Denmark | Potentiometric method | Once per 8 h-shift. | 4,5% | 2–8 | mmol/l |
Sodium | ABL 800Flex | Radiometer Medical ApS, Brønshøj, Denmark | Potentiometric method | Once per 8 h-shift. | 3% | 110–180 | mmol/l |
Thrombocytes | XE5000 | Sysmex Corporation KK, Kobe, Japan | Flow cytometry with dynamic focusing; traditional impedance technology for very low and very high PLT counts | Once per 8 h-shift. | 13,5% | 40–≤150 | 109/l |
8,5% | 150–≤300 | ||||||
7,5% | 300–700 | ||||||
Troponin I | Access 2 | Beckman Coulter Inc., Brea, United States | electrochemiluminescence immunoassay | 4 times per 8 h-shift. | 20% | 0,1–35 | μg/l |