Shiloh
Editor, Senior Moderator
Source: http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/45318
Avoid New Lyme Culture Test, Say CDC and FDA
Published: Apr 18, 2014
By Nancy Walsh, Senior Staff Writer, MedPage Today
CDC and the FDA have again cautioned the public about the use of an unapproved test for diagnosing Lyme disease...
...The culture technique, published in the International Journal of Medical Sciences, "incorporates [a] two-step process that consists of a short-term starter culture that is used to seed a long-term phase, each utilizing different cultivation environments. Combining the two phases allows for more rapid initial growth and ultimately a higher yield than has previously been reported," the authors stated.
They further reported that they were able to demonstrate growth of the pathogen from 50 seropositive individuals and an additional 72 patients with Lyme disease, with positive cultures in 47% after 6 days and in 94% after 4 months.
However, CDC subsequently reviewed the methods and results. The analysis raised "serious concerns about false-positive results caused by laboratory contamination and the potential for misdiagnosis," the agency said in its weekly report....
Avoid New Lyme Culture Test, Say CDC and FDA
Published: Apr 18, 2014
By Nancy Walsh, Senior Staff Writer, MedPage Today
CDC and the FDA have again cautioned the public about the use of an unapproved test for diagnosing Lyme disease...
...The culture technique, published in the International Journal of Medical Sciences, "incorporates [a] two-step process that consists of a short-term starter culture that is used to seed a long-term phase, each utilizing different cultivation environments. Combining the two phases allows for more rapid initial growth and ultimately a higher yield than has previously been reported," the authors stated.
They further reported that they were able to demonstrate growth of the pathogen from 50 seropositive individuals and an additional 72 patients with Lyme disease, with positive cultures in 47% after 6 days and in 94% after 4 months.
However, CDC subsequently reviewed the methods and results. The analysis raised "serious concerns about false-positive results caused by laboratory contamination and the potential for misdiagnosis," the agency said in its weekly report....