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Clinical study to evaluate Advanced Laboratory Services' Borrelia culture test

Posted: Wed 22 Jun 2016 2:02
by Martian
Remember Advanced Laboratory Services and their Lyme culture test?

Apparently they now want to conduct a study to Evaluate their Borrelia diagnostic test in subjects with early stage or late stage Lyme disease.

Source and more info: https://clinicaltrials.gov/ct2/show/study/NCT02741609
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease (ALSIBDT)

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2016 by Advanced Laboratory Services, Inc.

Sponsor:
Advanced Laboratory Services, Inc.

Information provided by (Responsible Party):
Advanced Laboratory Services, Inc.

ClinicalTrials.gov Identifier:
NCT02741609

First received: April 6, 2016
Last updated: June 14, 2016
Last verified: June 2016
Purpose

This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease.

This is an 8 month study. Subjects entering the study will have two blood samples collected one month apart if they have early Lyme disease and one blood sample collected if they have late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and exclusion criteria will be entered into the study. Subjects will be assigned a subject number upon entry and this number will be retained throughout the study.
Further study details as provided by Advanced Laboratory Services, Inc.:

Primary Outcome Measures:
  • Diagnostic accuracy of the Advanced Laboratory Services, Inc. (ALSI) Borrelia Diagnostic Test (BDT) culture, for positive and negative predictive value, as compared to conventional microbiological methods. [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
  • Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value. [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value. [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 300
Study Start Date: April 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

Re: Clinical study to evaluate Advanced Laboratory Services' Borrelia culture test

Posted: Wed 22 Jun 2016 3:23
by ChronicLyme19
"Have late Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with late stage Lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis."

Interesting they don't call out other neuro symptoms other than facial palsy.

Re: Clinical study to evaluate Advanced Laboratory Services' Borrelia culture test

Posted: Wed 22 Jun 2016 3:27
by ChronicLyme19
Immune deficiency significant enough to render serological tests less reliable.
It also slightly annoys me that immune deficient folks cannot participate, even tho it's a study on a CULTURE. My guess is they want to compare it to existing immune response based tests.

Then there's the fact that Lyme screws up your immune system, so anyone having an immune based test could be considered compromised.