General occupational safety and health rules subdivision z toxic and hazardous substances

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• The following cephalosporin antibiotics have been shown to affect CREA results when present at the indicated concentrations. System inaccuracies (bias) due to these substances are greater that 0.1 mg/dL [8.84 µmol/L] at CREA concentrations of:

Antibiotic

Peak serum level ^8,10

Drug concentration

mg/dL

[mmol/L]

mg/dL

[mmol/L]

Effect

Cephalothin

Cephoxitin

1-6

2.0

0.2-1.5

0.5

100

5.0

25.2

1.2

 20-25%

 35-40%

• The single wavelength measurement used in this method eliminates interference from chromophores whose 510 nm absorbance is constant throughout the measurement period.

• Each laboratory should determine the acceptability of its own blood collection tubes and serum separation products. Variations in these products may exist between manufacturers and, at times, from lot to lot.

Procedure:

Test Materials
Item	II, III Du Pont Cat. No.	IV, SX Du Pont Cat. No.	V Du Pont Cat. No.
ACA® CREA Analytical Test Pack	701976901	701976901	701976901
Sample System Kit, or	710642901	710642901	713697901
Micro Sample System Kit, and	702694901	710356901	NA
Micro Sample System Holders	702785000	NA	NA
DYLUX® Photo-Sensitive Printer Paper	700036000	NA	NA
Thermal Printer Paper	NA	710639901	713645901
Du Pont Purified Water	704209901	710615901	710815901
Cell Wash Solution	701864901	710664901	710864901

Test Steps: The operator need only load the sample kit and appropriate test pack(s) into a properly prepared ACA® discrete clinical analyzer. It automatically advances the pack(s) through the test steps and prints a result(s). See the Instrument Manual of the ACA® analyzer for details of mechanical travel of the test pack(s).

Preset Creatinine (CREA) Test Conditions

Sample volume: 200 µL.
Diluent: purified water.
Temperature: 37.0 ± 0.1 °C.
Reaction period: 29 seconds.
Type of measurement: rate.
Measurement period: 17.07 seconds.
Wavelength: 510 nm.
Units: mg/dL [µmol/L].

Calibration: The general calibration procedure is described in the Calibration/Verification chapter of the Manuals.

The following information should be considered when calibrating the CREA method.

Assay range: 0-20 mg/mL [0-1768 µmol/L].^²
Reference material: Protein containing primary standards^³ or secondary calibrators such as Du Pont Elevated Chemistry Control (Cat. #790035903) and Normal Chemistry Control (Cat. #790035905).^⁴
Suggested calibration levels: 1,5,20, mg/mL [88, 442, 1768 µmol/L].
Calibration scheme: 3 levels, 3 packs per level.
Frequency: Each new pack lot. Every 3 months for any one pack lot.

Preset Creatinine (CREA) Test Conditions
Item	ACA® II analyzer	ACA® III, IV, SX, V analyzer
Count by ………………………………	One (1) …………………………... [Five (5)] ………………………….	NA
Decimal Point ………………………...	0.0 mg/dL ………………………...	000.0 mg/dL
Location ……………………………….	[000.0 µmol/L] …………………...	[000 µmol/L]
Assigned Starting ……………………	999.8 ……………………………..	-1.000 E1
Point or Offset C_O…………………….	[9823.] …………………………….	[-8.840 E2]
Scale Factor or Assigned …………..	0.2000 mg/dL/count ^h …………..	2.004 E-1 ^h
Linear Term C₁^⁵ ……………………..	[0.3536 µmol/L/count] …………..	[1.772E1]

Quality Control: Two types of quality control procedures are recommended:

• General instrument check. Refer to the Filter Balance Procedure and the Absorbance Test Method described in the ACA® Analyzer Instrument Manual. Refer also to the ABS Test Methodology literature.

• Creatinine method check. At least once daily run a CREA test on a solution of known creatinine activity such as an assayed control or calibration standard other than that used to calibrate the CREA method. For further details review the Quality Assurance Section of the Chemistry Manual. The result obtained should fall within acceptable limits defined by the day-to-day variability of the system as measured in the user’s laboratory. (See SPECIFIC PERFORMANCE CHARACTERISTICS for guidance.) If the result falls outside the laboratory’s acceptable limits, follow the procedure outlined in the Chemistry Troubleshooting Section of the Chemistry Manual.

A possible system malfunction is indicated when analysis of a sample with five consecutive test packs gives the following results:

Level

1 mg/dL

[88 µmol/L]

20 mg/dL

[1768 µmol/L]

>0.15 mg/dL

[>13 µmol/L]

>0.68 mg/dL

[>60 µmol/L]

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