Professional Documents
Culture Documents
UREAL
Urea/BUN
Indicates cobas c systems on which reagents can be used
Order information Roche/Hitachi cobas c systems
Urea/BUN cobas c 311 cobas c 501/502
500 tests Cat. No. 04460715 190 System-ID 07 6303 9
Calibrator f.a.s. (12 x 3 mL) Cat. No. 10759350 190 Code 401
Calibrator f.a.s. (12 x 3 mL, for USA) Cat. No. 10759350 360 Code 401
Precinorm U plus (10 x 3 mL) Cat. No. 12149435 122 Code 300
Precinorm U plus (10 x 3 mL, for USA) Cat. No. 12149435 160 Code 300
Precipath U plus (10 x 3 mL) Cat. No. 12149443 122 Code 301
Precipath U plus (10 x 3 mL, for USA) Cat. No. 12149443 160 Code 301
Precinorm U (20 x 5 mL) Cat. No. 10171743 122 Code 300
Precipath U (20 x 5 mL) Cat. No. 10171778 122 Code 301
Diluent NaCl 9 % (50 mL) Cat. No. 04489357 190 System-ID 07 6869 3
Urea/BUN
Order information
COBAS INTEGRA 500 Tests Cat. No. 04460715 190 Indicates analyzer(s) on which cobas c pack can be
Urea/BUN System-ID 07 6303 9 used
Calibrator f.a.s. 12 3 mL Cat. No. 10759350 190
Calibrator f.a.s. (for USA) 12 3 mL Cat. No. 10759350 360
System-ID 07 3718 6
Precinorm U 20 5 mL Cat. No. 10171743 122
System-ID 07 7997 0
Precipath U 20 5 mL Cat. No. 10171778 122
System-ID 07 7998 9
Precinorm U plus 10 3 mL Cat. No. 12149435 122
Precinorm U plus (for USA) 10 3 mL Cat. No. 12149435 160
System-ID 07 7999 7
Precipath U plus 10 3 mL Cat. No. 12149443 122
Precipath U plus (for USA) 10 3 mL Cat. No. 12149443 160
System-ID 07 8000 6
UREAL
Urea/BUN
Calculation Lower limits of measurement
Roche/Hitachi cobas c systems automatically calculate the analyte Lower detection limit of the test
concentration of each sample. Serum/plasma
Conversion factors: mmol/L urea x 6.006 = mg/dL urea 0.5 mmol/L (3.0 mg/dL urea, 1.4 mg/dL urea nitrogen)
mmol/L urea x 0.06006 = g/L urea The lower detection limit represents the lowest measurable analyte
mmol/L urea nitrogen x 2.801 = mg/dL urea nitrogen level that can be distinguished from zero. It is calculated as the value
mmol/L urea nitrogen x 0.02801 = g/L urea nitrogen lying three standard deviations above that of the lowest standard
mg/dL urea x 0.467 = mg/dL urea nitrogen (standard 1 + 3 SD, repeatability, n = 21).
Urine
When 24-hour urine is used as the specimen, multiply the result by the 1 mmol/L (6 mg/dL urea, 2.8 mg/dL urea nitrogen)
24-hour volume to obtain values in g or mmol/24 hours. The lower detection limit represents the lowest measurable analyte
level that can be distinguished from zero. It is calculated as the value
Limitations - interference7
lying three standard deviations above that of the lowest standard
Criterion: Recovery within 10 % of initial value at a urea concentration (standard 1 + 3 SD, repeatability, n = 21).
of 8.3 mmol/L (49.8 mg/dL urea, 23.2 mg/dL urea nitrogen).
Expected values
Serum/plasma
Icterus: No significant interference up to an I index of 60 (approximate Urea:10
conjugated and unconjugated bilirubin concentration: 1026 mol/L (60 mg/dL)). Serum/plasma
Hemolysis: No significant interference up to an H index of 1000 (approximate Adults ( 65 y) < 8.3 mmol/L (< 50 mg/dL)
hemoglobin concentration: 621 mol/L (1000 mg/dL)). Adults (> 65 y) < 11.9 mmol/L (< 71 mg/dL)
Lipemia (Intralipid): No significant interference up to an L index of Urine
1000. There is poor correlation between the L index (corresponds 24-hour urine < 580 mmol/24 h (< 35 g/24 h)
to turbidity) and triglycerides concentration.
1st morning urine 150-500 mmol/L (0.9-3.0 g/dL)
Ammonium ions may cause erroneously elevated results.
Drugs: No interference was found at therapeutic concentrations Urea nitrogen (BUN):
using common drug panels.8,9 Serum/plasma11
In very rare cases, gammopathy, in particular type IgM (Waldenstrms Adults (1860 years) 6-20 mg/dL
macroglobulinemia), may cause unreliable results. Adults (6090 years) 8-23 mg/dL
Urine Infants (< 1 year) 4-19 mg/dL
Drugs: No interference was found at therapeutic concentrations Infants/children 5-18 mg/dL
using common drug panels.9 Urine
For diagnostic purposes, the results should always be assessed in conjunction 24-hour urine12 800-1666 mg/dL (12-20 g/24 h)a
with the patients medical history, clinical examination and other findings. a) Based on an average urine output of 1.2-1.5 L/24 h
ACTION REQUIRED Each laboratory should investigate the transferability of the expected values to
Special Wash Programming: The use of special wash steps is mandatory its own patient population and if necessary determine its own reference ranges.
when certain test combinations are run together on Roche/Hitachi cobas c
systems. The latest version of the Carry over evasion list can be found with Specific performance data
the NaOHD/SMS/Multiclean/SCCS or the NaOHD/SMS/SmpCln1 + 2/SCCS Representative performance data on the analyzers are given below.
Method Sheets. For further instructions refer to the operator manual. Results obtained in individual laboratories may differ.
cobas c 502 analyzer: All special wash programming necessary for avoiding
Precision
carry over is available via the cobas link, manual input is not required.
Precision was determined using human samples and controls in an internal
Where required, special wash/carry over evasion programming must
protocol. Repeatability* (n = 21), intermediate precision** (serum/plasma:
be implemented prior to reporting results with this test.
3 aliquots per run, 1 run per day, 21 days; urine: 3 aliquots per run, 1 run
Limits and ranges per day, 10 days). The following results were obtained:
Measuring range Serum/plasma
Serum/plasma Repeatability* Mean SD CV
0.5-40 mmol/L (3.0-240 mg/dL urea, 1.4-112 mg/dL urea nitrogen) mmol/L (mg/dL urea) mmol/L (mg/dL urea) %
Determine samples having higher concentrations via the rerun function. Precinorm U 6.74 (40.5) 0.07 (0.4) 1.0
Dilution of samples via the rerun function is a 1:3 dilution. Results from samples Precipath U 23.4 (141) 0.2 (1) 0.9
diluted by the rerun function are automatically multiplied by a factor of 3.
Human serum 1 9.18 (55.1) 0.09 (0.5) 1.0
Urine Human serum 2 15.1 (90.7) 0.1 (0.6) 0.9
1-2000 mmol/L (6-12000 mg/dL urea, 2.8-5600 mg/dL urea nitrogen)
Determine samples having higher concentrations via the rerun function. Dilution Intermediate Mean SD CV
of samples via the rerun function is a 1:1.8 dilution. Results from samples precision** mmol/L (mg/dL urea) mmol/L (mg/dL urea) %
diluted by the rerun function are automatically multiplied by a factor of 1.8. Precinorm U 6.66 (40.0) 0.08 (0.5) 1.2
Determine samples having concentrations lower than the technical limit Precipath U 23.2 (139) 0.3 (2) 1.1
of 40 mmol/L (240 mg/dL urea and 112 mg/dL urea nitrogen) via the Human serum 3 9.13 (54.8) 0.10 (0.6) 1.1
rerun function. Samples are measured undiluted. Human serum 4 14.9 (89.5) 0.2 (1.2) 1.3