What to know
The sections below provide cardiovascular disease (CVD) responses to Cholesterol Reference Method Laboratory Network (CRMLN) Frequently Asked Questions.
CRMLN FAQs
Why is the certification process important?
Certification ensures that measurement results for blood lipids obtained in patients and research studies can be compared with those used in current clinical guidelines.
What is involved in the certification process?
Manufacturer or clinical laboratory interested in participating can contact a CRMLN member laboratory for further information. Additional details can be found at Procedures for Certification of Manufacturers and Procedures for Certification of Clinical Laboratories.
Can more than one instrument system or model be certified with the same set of samples?
Yes. This is cost effective and highly desirable. However, this requires special coordination of activities. Contact your CRMLN member laboratory for further details.
What are the certification criteria?
The criteria can be found here: Procedures for Certification of Manufacturers.
Is the freshness limit of the samples truly critical?
Yes. Freezing and modification of the serum can lead to samples behaving differently from regular patient samples. This can result in incorrect analytical performance assessments. Please contact your CRMLN laboratory for information about appropriate sample collection.
Can CDC send me samples with assigned values to check out my method first?
Yes. CDC may be able to provide samples that are reference value assigned with TC, TG and HDL depending on availability. These samples are intended to be used as trueness control. Please contact CDC at cdclsp@cdc.gov for more detail. You may also contact CRMLN members for such samples.
Can more than one instrument system or model be certified with the same set of samples?
Yes. More than one instrument from the same model may be used as long as they have different serial numbers. In this way, manufacturers may increase the number of runs that can be accomplished within a time period. However, different models must perform all of the analyses and be certified separately.
My company manufactures point-of-care (POC) instruments that are factory-calibrated. Are we required to define our runs the same way as traditional clinical analyzers?
Yes. A run for POC instruments is defined as an analysis of two samples in duplicate every two hours.
LSP FAQs
How does LSP certification work?
LSP provides participants with 12 blinded samples per quarter. Participants analyze one sample per week and submit data every quarter. Participants are evaluated and receive reports quarterly. If the data meet the criteria for total cholesterol, total glycerides and HDL-cholesterol, certificates are also issued. For Apo AI and Apo B, reports are provided instead of certificates because reference measurement procedures are not available for these analytes.
What are the analytes that are evaluated in LSP?
We evaluate results for total cholesterol, total glycerides and HDL-cholesterol, Apo AI and Apo B. Certificates are issued for total cholesterol, total glycerides and HDL-cholesterol only.
Can my laboratory apply at any time?
Yes, laboratories may enroll for any quarter (subject to sample availability).