911 Cholestech LDX
| Document Name: Cholestech LDX | Document Number: 911 | Revision Date: 13AUG2024 | Supersedes: 710.00 |
| Target Group: Research Personnel | Approval Date: 20Dec2024 | Effective Date: 01Jan2025 | Training Required: -Bloodborne Pathogens |
Purpose
To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.
This Standard Operating Procedure (SOP) ensures proper use, maintenance and operations of the Cholestech LDX system with research participants. Attachment template includes:
A: Cholestech LDX QC Cholestech LDX Patient Result Log
Responsibilities
The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.
Definitions
Pipette: A slender tube attached to or incorporating a bulb, for transferring or measuring out small quantities of liquid.
Capillary Tube: A thin tube, usually made out of glass, plastic or metal through which fluid samples may be collected and flow through.
Procedures
1. Setup
- Attach cables as indicated in the Quick Reference Guide (Appendix NN)
2. Optics Check
- To be run once each day before participant samples are tested and after the analyzer has been moved or serviced.
- Press the RUN button to open the drawer. Place the Optics Check Cassette in the drawer and press the RUN button to close the drawer.
- Check the four numbers on the display to ensure they are within the range printed on the Optics Check Cassette. If they are not the analyzer will be disabled until a check is run that is within range.
3. Controls
- To be run with each new lot and/or shipment of cassettes
- Controls should be stored and run according to the manufacturer’s instruction.
- Controls must be at room temperature before testing.
- Use the MiniPet Pipette and tips to measure and dispense controls into the cassettes.
- Place the cassette in the drawer and press RUN immediately. Record the results on a Quality Control Log.
- Results must be within the ranges indicated on the controls prior to testing patient samples.
4. Test Procedure
- Open the drawer and prepare a cassette.
- Properly clean the fingerstick sample site with an alcohol pad.
- Perform a fingerstick with a single use lancet and wipe off the first large drop of blood.
- Fill a capillary tube within 10 seconds without allowing any bubbles into the tube.
- Dispense the sample into the cassette well by pushing down on the plunger.
- Place the cassette in the drawer and press RUN.
- The analyzer will beep when testing is complete, and the drawer will open. Place everything that touched the blood sample into a biohazardous waste container.
- Press DATA to view the results, the results will also be printed when the test is finished.
5. Informed Consent Language
A needle will be used to make a tiny hole in your finger. The blood will be used to check your cholesterol, triglyceride, and sugar level.
Risks associated with finger stick:
A finger stick is a bit uncomfortable and may cause some soreness and bruising. Very rarely, the site can become infected.
References: Cholestech LDX Quick Reference Guide
Attachments: A: Cholestech LDX QC Cholestech LDX Patient Result Log
Appendices: None
Approver: CTRU Medical Director