Total Bilirubin 700nm
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Synermed® IR700 total bilirubin is not based upon the diazo reaction and is therefore not subject to chemical interference from hemoglobin as are all diazo methods. Urinary indicans which are measured by most automated diazobilirubin methods have no effect in the infrared method. Chromatic interferences are minimized by detection at 700 nm where hemoglobin and lipemia have little absorbance. The method is optimized for performing bilirubin assays on sera which contain hemoglobin along with high levels of bilirubin, such as often occurs with pediatric samples.
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- Mono Reagent
- Ready-to-Use Liquid Reagent
- Minimizes Chromatic Interferences
- Eliminates Troublesome Negative Values
- Room Temperature Stability
- Useful After Infusion With Artificial Blood
- Reliable Values on Uremic Patients
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Principles of the Reaction
The sample containing both conjugated and unconjugated bilirubin is dissolved in the reagent and both conjugated and unconjugated bilirubin are oxidized in the presence of the electron transfer agent KHC3 to form a stable blue-green infrared light absorbing chromophore cholecyanin.
| KHC3 Bilirubin -> cholecyanin (yellow) (blue-green) |
The reaction product is detected at 700 nm in the near-infrared region of the spectrum.
Analytical Range
Most applications of the procedure have been found to be linear to 30 mg/dL (513 µmol/L) bilirubin.
Limitations of the Procedure
- The interference from hemoglobin was tested using the application to the IR200 and no interference outside the imprecision of the test was noted up to levels of 500 mg/dL hemoglobin.
- The interference from lipemia (tested as Intralipid) was determined using the application to the IR200 and no interference outside the imprecision of the test was noted up to levels of 500 mg/dl lipemia. See Chart below.
- The interference from a hemoglobin based blood substitute was tested and no interference outside the imprecision of the test was observed up to levels of 1000 mg/dL. See Chart below.
- Urinary indican was tested at levels of 0.5 mM and 1.0 mM and no interference was observed.
Expected Values
Bilirubin levels will vary with age, sex, and diet. It is strongly recommended that each laboratory establish an expected range for the local population. The normal range for total bilirubin in serum is reported to be 0.1-1.4 mg/dl (1.7-23.9 µmol/L).
Special Performance Characteristics
- The Synermed IR700 Total Bilirubin methodology as applied to the IR200 analyzer was correlated to the Synermed IR450 Total Bilirubin method . The calculated linear regression on 40 samples ranging from approximately 0.2 to 25.2 mg/dl with Synermed IR 700 results on the Y-axis was: Y = 1.00X + 0.04 mg/dL with a correlation coefficient of 0.998.
- The sensitivity of the procedure is such that an absorbance change of 0.001 (as measured in a 1 cm light path) will detect as little as 0.04 mg/dL bilirubin.
- The within run precision of the method as applied to the Synermed IR200 analyzer was determined by assaying samples of quality control materials at two levels of bilirubin concentration:
Mean SD CV 0.9 mg/dL 0.06 6.2% 7.1 mg/dL 0.07 1.0% - The run to run reproducibility of the method as applied to the Synermed IR200 analyzer was determined from the values obtained by 5 replicate analyses of quality control material assayed over a 20 batch period over 5 days. The following results were obtained:
Mean SD CV< 1.0 mg/dL < 0.08 < 8.3% 6.8 mg/dL 0.27 3.9%
Product Packaging and Storage
| Cat No. | Product Name | Packaging | Package Volume (mL) | Storage |
| IR450-X | Bilirubin, Total DS | 1x250 mL + 1x50 mL | 300 | 0-4° C |
| IR450 | Bilirubin, Total DS | 3x250 mL + 3x50 mL | 900 | 0-4° C |
| IR451-L | Bilirubin, Total - DS Reagent | 6x1000 mL | 6,000 | 0-4° C |
| IR452-L | Bilirubin, Total - DS Oxidant | 6x250 mL | 1,500 | 0-4° C |
| IR700-X | Bilirubin, Total 700 nm (Human) | 2x250 mL | 500 | 0-4° C |
| IR700 | Bilirubin, Total | 6x250 mL | 1,500 | 0-4° C |
| IR700-L | Bilirubin, Total 700 nm (Vet) | 6x1000 mL | 6,000 | 0-4° C |
| IR700-911 | Bilirubin, Total | 8x50 mL | 400 | 0-4° C |
| IR700-WK | Bilirubin, Total | 4x55mL | 220 | 0-4° C |
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