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Quality Control for the
Erythromycin Breath Test


Instrumentation

All 14C measurements at Metabolic Solutions, Inc are made on a Packard 2100TR Liquid Scintillation counter.

System Calibration

A third party independently calibrates the system every six months.  Additionally, a minimum of once every twenty-four hours the system automatically adjusts each photomultiplier tube to balance its response to sample activity and calibrate the spectrum analyzer in keV (a process called self-normalization).

System Validation

The system has been validated with respect to accuracy, intra-run precision, inter-run precision and stability.

The following values were established for each validation parameter:

Accuracy:
                                       High level control = within 0.10%

                                       Low level control = within 0.19%

Intra-run Precision:                                       
                                       High level control = 0.11%

                                       Low level control = 0.22%

Inter-run Precision:

                                       High level control = 0.33%

                                       Low level control = 0.42%


Stability: Prepared breath samples (hyamine trapped CO2) are stable for two weeks.

System Monitoring

During each run, three (3) commercial controls (background, low level and high level) are assayed three times and a mean calculated.  All samples must be within 2SD for the run to be acceptable.  The mean values, standard deviations and 2SD range are shown below for these three system monitoring controls:

Sample Mean (dpm) SD (dpm) Range (dpm)
Background 41.8 2.1 37.6-46.0
Low Level Control 42615 181 42253-42977
High Level Control 129216 423 128370-130062

Metabolic Solutions, Inc., 460 Amherst Street, Nashua, NH 03063

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