Patients have endless curiosity about Lyme tests, especially confusing Western Blots. It is no surprise since mainstream medicine keeps pushing the same lies.
Lie #1: The only test you have to order is "Lyme serology." This is the ELISA or EIA followed by a reflex Western Blot. (The second step, Western Blot, is only performed when the ELISA is positive). The technology has improved a lot. The ELISA is highly sensitive and the Western Blot very specific. Other laboratories (always referring to IgeneX) have invalid tests which are not FDA approved and are not peer reviewed. Do not use the laboratories. (And make sure your patients stay off the Internet).
Truth: Despite the claim, the technology has not improved and does not continue to improve. The technology is the same. The FDA regulates drugs and medical devices, not laboratory testing. Biomedical companies may develop off the shelf test kits and market these diagnostic test kits to clinical laboratories. These diagnostic test kits are considered a "medical device" and thus come under the purview of the FDA. In general, test kits sold for the mass market are designed to be easy to perform or idiot proof to the extent possible. Commercial laboratories like Labcorp and Quest purchase such ready-made kits for testing patient samples for Lyme disease. These commercial test kits are vetted by the FDA and considered "accurate:" They do not change year-to-year. These tests are not upgraded anymore than a tablet of aspirin is. Lyme ELISA and Western Blot from Labcorp/Quest done in 2005 and 2013 are the same. Despite claims to the contrary, the test is not better, the ELISA is not more sensitive or the Western Blot more specific.
These tests are not peer-reviewed. I do not know what this means. The tests are approved by the FDA. Which peers are we talking about?
Specialty laboratories like IgeneX and Stony Brook do better Lyme tests. They make better, more complex and accurate test kits for use only in their laboratory facility. They do not manufacture testing kits for resale to other laboratories. Because of this the FDA has no involvement whatsoever in these laboratory activities. This is not something the FDA does. Laboratory specific testing methods are not a medical device. Why is this so complicated? OK -- so you might wonder, how do we know these facilities do a good job. Clinical laboratories are licensed by and regulated by states agencies who perform routine proficiency tests to make sure the labs do a good job. New York state goes a step further. Not trusting other state laboratory licensing boards, it does its own proficiency testing in addition to those performed by the state of origin of the laboratory. So when New York licensing authorities allow IgeneX to operate within its jurisdiction, you can be assured that the lab has passed the mustard. Despite this, physicians of authority in New York and elsewhere continue to disparage IgeneX calling it such things as a "quack lab." They say IgeneX for example is not validated, peer reviewed or FDA approved. These claims are misleading obfuscations, prevarications or lies, plain and simple. Why do they want us to use less accurate testing methods??
Lie #2: Although the standard Lyme tests are not accurate in early Lyme disease and may miss 40% of cases, the test is virtually 100% accurate when performed later in the course of the disease (generally after 6 weeks). In virtually all cases patients convert from IgM bands to IgG bands. When this does not occur the original positive 2-tier ELISA/IgM Western Blot positive test was in fact a false positive. False positives are common. Many other common ailments like mono and rheumatoid arthritis can cause false positive Lyme tests. Many patients diagnosed with Lyme disease showing only positive IgM Western Blots never had Lyme in the first place. The conversion to the 5/10 IgG bands is dependable.
Truth: I do not know what planet they are on. None of the above is true. The CDC designated the 2-tier test for surveillance was designed to be exceedingly accurate: about 100% accurate. I am sorry to report that Lyme did not read the rule book about IgM and IgG antibodies. Very few patients ever develop a significant IgG response. The infamous magic number, 5/10 seems to have been made from whole cloth. The formula was agreed upon in a weekend meeting in Dearborn Michigan of CDC scientist and national laboratories directors.( 19 years ago in 1994 and never re-visited). The point of the exercise was to find a formula that would put various laboratories and researchers on the same page. This test was designated for surveillance purposes. A positive means you were definitely infected with Lyme disease. It was called a national surveillance test and retains that name to this day. The famous CDC test was never developed for purpose of making a clinical diagnosis of Lyme disease. Why is that complicated? Just to show the insanity of it all -- the same researcher, Dressler, who came up with the famous 5/10 also presented a 2/8 IgM band standard. This scheme was kicked out because his laboratory used the N40 strain instead of the B31 strain of Lyme. The assembled experts decided to use a formula of 2/4, changed to 2/3 for positive IgM criteria. Again, it was a tool designed to follow the number of cases of Lyme disease over time in different geographical locations. It would not have mattered it the 2/8 formula had been adopted instead of the 2/3 formula. By the way, the 4th band, #37, was dropped for technical reasons. These agreements were reached so that researches everywhere could read from the same sheet of music.
As for false positives , these appear to be exceedingly rare. As far as I can tell a positive 2-tier CDC test again is virtually 100% accurate. Of course most patients suffering with Lyme disease do not have this result.