Text Box: Specimen Requirements and Handling Text Box: ELISA Western Blot Serum: 0.500 ml Serum: 1.000 ml CSF: 0.500 ml CSF: 2.000 ml CSF/Serum Pair: CSF 1.000 ml Serum 1.000 ml Blood specimens should be spun and separated before transporting. Specimens can be sent room temperature through the regular U.S. Postal Service as long as they are packaged in containers approved by the U.S. Postal Service, (free pre-addressed, postage paid regulation mailing containers in the accordance with the IATA packing instruction 650 along with requisition forms can be provided upon request) however we recommend they be sent either Priority Mail, Federal Express, DHL, or any other overnight or 2 day courier service. Not only will it reduce turn-around-time, but also provides tracking and proof of delivery. It is extremely critical to transport specimens in leak-proof containers and to package them sufficiently with an absorbent material to prevent breakage in transport. Specimens should be properly labeled with the patient’s first and last name on the specimen container. If the sample is originating from a doctor’s office, be sure to fill in the patient’s billing address, insurance information, ICD9 code, date of service, doctor’s license and UPIN number on the requisition form. Acute/Convalescent specimens or CSF/Serum pairs must be submitted together as paired specimens. All tubes should be properly and legibly labeled with the patient’s full name and date specimen was drawn. Each specimen must be accompanied with a matching request form. Upon completing the request form please keep the pink copy for your records. QC: Each 96 well ELISA plate that is run contains 15 different controls (with established ranges) representing high positives, low positives, and negatives run in duplicate and on different areas of the plate. All patient samples are run in duplicate and must replicate within 10%. If they do not replicate they are repeated. Lot to lot comparisons are performed with known specimens for every lot change of every component of the assays. QA: Our system performs a delta check on every patient sample when the results are entered. Disparate samples are repeated to confirm results. In addition, all worksheets and instrumentation print outs are reviewed daily by the Section Supervisor. Proficiency: We presently participate in both CAP and New York State DOH proficiency testing programs for Lyme Disease tests. This includes the ELISA and Western Blot test methodologies. We also participate in the CAP pipette calibration and linearity verification surveys. I hope that the information provided answers all of your questions. If you should have any further questions or require any additional information please feel free to let me know. I can be reached Monday-Friday 8:00 a.m.-4:30 p.m. (EST) by calling (631) 444-7965. We are looking forward to serving your laboratory needs for Lyme Disease testing. Sincerely, Cathy M. Van Allen MT(ASCP) Lyme Technical Service Representative The Laboratory for the Diagnosis of Lyme Disease

QA/QC Procedures