Creating an SOP for Students & Assessing the Role of CV% in Analyzer Performance

The purpose of this project was to create an SOP and to assess the performance of data collected. An SOP is needed for student use and for laboratory procedures that will facilitate the use of analyzer activities in the laboratory classroom. During analyzer training and assessment, assay control QC data was collected. Comparison of assay control QC data was compared to package insert and literature to assess analyzer performance during a period of training. To create an effective SOP, analyzer maintenance, calibration and control procedures were learned during hands-on training and learned skills were assessed by Abbott. To assess analyzer performance, training data was used to calculate calcium, cholesterol and albumin assay control CV%. Data for CV% calculation was collected from the c8000 analyzer. Two SOP’s pending final approval were created. They provide guidance on onboard analyzer supply and steps for maintenance, calibration and control procedures. Abbott Architect c8000 and i2000 analyzer maintenance, calibration and control procedures were learned and positively assessed. All calculated CV% results were below 5% and except for one inter-variability and one intra-variability control, all inter- and intra-variability CV% calculations were comparable to literature. Level 3 calcium and albumin calculated CV% 3.51 and 3.48 respectively were higher compared to package inserts 3.0 and 3.3 respectively. SOP content and CV% comparison was limited by consumable supply inventory. User SOP experience was not assessed. CV% comparability was impacted by a small training data set. The assessment of analyzer performance was limited to precision only.

“The Capstone experience can seem intimidating if one is not currently employed or does not have career experience in the sciences. This will not prevent you from successfully completing the capstone project. Professors within the Applied Biotechnology program can help but, this requires the student to ask. Program advisors are also an amazing resource and are invested in the success of students. This capstone project opportunity was presented by a UWP program advisor and was facilitated by a UWP professor. Both worked together to ensure this Capstone project met program requirements and presented an opportunity for student growth and success.

Feelings of inadequacy due to the lack of experience can be overwhelming at times but those can be overcome through humility. It is important to remember that the Capstone project although a requirement for completion of the Applied Biotechnology program is itself a learning opportunity. Learning implies developing an understanding and skills of something new. The Capstone environment provides a new experience. The lack of experience is not a factor in project success but rather the act of silence is. The most important thing realized about this program and Capstone is that it enforces what has been learned and provides the opportunity to demonstrate it.”