Calibrators and control samples for bilirubinometers.

The different matrix properties of neonatal serum and commercial control samples can lead to considerable errors in the calibration and control of bilirubinometers. These difficulties can be avoided by calibration with serum from healthy adults which is supplemented with unconjugated bilirubin. But this procedure is impracticable for most routine laboratories. Under certain preconditions, control samples, with bilirubin concentrations determined with correctly calibrated bilirubinometers or spectrophotometers, are also suitable as calibrators. This was established by determination of the bilirubin concentration of 16 different control samples, using both the reference method and correctly calibrated bilirubinometers or spectrophotometers in three or four specialist laboratories. This was also confirmed in several interlaboratory surveys, some involving up to 72 laboratories. The results of these investigations show that a control sample should be used for the calibration of a bilirubinometer only if it meets the following preconditions: 1. There should be no significant difference between the bilirubin values determined with the reference method and with a correctly calibrated spectrophotometer or bilirubinometer. 2. The bilirubin concentration should lie in the range 230-300 mumol/l. The photometric response of bilirubinometers has a limited linear range, so that analytical results greater than 300 mumol/l must be rated as basically unreliable.