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Lyme Disease Testing

For Tick Testing Information, Click here. Tick submission form can be downloaded PDF Submission form, Online Submission Form

Clongen Laboratories offer Lyme Disease Testing by PCR and Western Blot.  To order test, please fill out the Test Request Form and include with your specimen.  Patients are responsible for payment.   Request test 124 (Lyme Disease) for Lyme Test by PCR, test 124A for Lyme Test by Western Blot, or test 124B for both PCR and Western Blot testing,

Tick ImageImportant:  If you have been bitten by a tick, be very careful when removing it.  Do not use heat, petroleum, or any other chemical while attempting to remove it from the bite site.  Also, you have to be careful not to squeeze the gut contents into the bite site as this may increase the chances for bacterial transmission.  Transfer the tick into a plastic container with a tight seal or to a zip lock bag if it is dead and send it to the lab. for testing.  Ticks should be shipped cooled overnight.  There is no need for a doctor's order to run the test, however, it is highly recommended that you provide us with a doctor's fax number so that we can keep your family physician informed. 

If the result is negative, the patient should pay special attention to the bite site as there are other organisms that can be transmitted by ticks (e.g. Ehrlichia and Babesia species).  Please seek immediate medical attention if there are any unusual symptoms associated with the tick bite.  Not all Lyme cases produce the typical "Bull's Eye" rash.  It is recommended to test for the presence of Lyme disease antibodies if you live in a high risk area for Lyme's disease.  Western Blotting is much more sensitive and more specific than EIA.  Your final report will include all the positive bands showing on the blot even if the result is considered negative (there is a minimum number of bands that have to appear before a test is called positive).

Tick testing (dead or alive) is $75 - Test 124C

Background

Lyme disease (LD) was named in 1977 when arthritis was observed in a cluster of children in and around Lyme, Connecticut.  LD is a multisystem and multistage infection caused by a tick-borne spirochete.  It is the most common arthropod-borne infection in the United States.  There has been a steady increase in the incidence of the disease over the years and the distribution of the disease in the United States matches the distribution of ticks of the genus Ixodes.  The tick Ixodes scapularis is responsible for the transmission of the LD bacteria in the North Eastern and North Central United States.  On the Pacific Coast, the bacteria are transmitted to humans by the western black-legged tick (Ixodes pacificus). Ixodes ticks are much smaller than common dog and cattle ticks.  In their larval and nymphal stages, they are no bigger than a pinhead. Ticks feed by inserting their mouths into the skin of a host and slowly taking in blood.  Ixodes ticks are most likely to transmit infection after feeding for two or more days.

The disease is caused by Borrelia burgdorferi, a spriochete sharing sequence homology with Treponema and LeptospiraBorrelia burgdorferi is the longest and narrowest of the Borreliae.  It contains several antigens that are important in pathogenesis and diagnosis including outer surface proteins, OspA through OspG, that are located on plasmids and a 41 kDa flagellar protein.  Although there are three geno-species recognized within the Borrelia burgdorferi (B. burgdorferi sensu lato):  B. burgdorferi sensu stricto, B. garinii, and B. afzelii, strains found in the United States are relatively homogeneous and conform to the definition of B. burgdorferi sensu stricto.  The two other species are present in Europe and Asia and produce mixed infections in humans and mice.  B. garinii is mainly associated with neuroborreliosis whereas B. afzelii is associated with arthritis and skin lesions.  The risk of developing LD following a tick bite is less than 0.01 and it has been shown that it is not cost-effective to recommend prophylactic treatment for everyone that has been bitten by a tick. 

Like other spirochetal infections, the signs and symptoms of LD occur in stages and involve a variety of tissues and organs including the skin, joints, heart and nervous system. Early infection (stage 1) involves erythema migrans (EM), an annular skin rash that is seen days to weeks after a tick bite.  Hematogenous dissemination of the bacteria days to weeks later (stage 2) can result in multiple skin lesions (secondary EM) as well as meningitis, rediculoneuritis, arterioventricular blockage, myocarditis and oligoarticular arthritis.  Persistent infections (stage 3) occurs months to years following the initial exposure and can be associated with acrodermatitis chronica atrophicans, various encephalopathies and persistent arthritis.  Clinical signs of LD among patients in North America tend to differ from those in Europe and Asia due to differences in Borrelia species in different parts of the world.  The CDC has developed a case definition of LD for surveillance purposes that includes either physician-diagnosed EM along with solitary lesions of at least 5 cm or at least one joint, cardiac or neurological manifestation along with laboratory diagnosis. 

Culture isolation of B. burgdorferi sensu lato remains the gold standard for diagnosis although the recovery rate decreases as the disease stages advance with the most likelihood of isolating the bacteria in Barbour-Stoenner-Kelly medium (BSK or modified BSK) is in stage one EM.  Detection of the bacteria in culture is accomplished using dark field microscopy, or by fluorescent microscopy using acridine orange stain or a specific antibody to the bacteria labeled with fluorescein.  Serologic testing using antibodies to outer surface proteins (OsP-A to G), the 41 KDa flagellin protein and other heat shock proteins can be used although there have been reports about down regulation of OsPs A-G in the bacteria after a blood meal.  Molecular testing is being widely used for the detection of the spirochete in lesions even before the appearance of antibodies in the patient's serum.  It was shown that PCR has close to 99% specificity and an average of 73% sensitivity and that molecular testing produces positive results in cases where the patients had already received prophylactic treatment and no antibodies or viable bacteria have been detected.  The bacterial DNA tends to be detectable by PCR in joints and tissues for weeks following antimicrobial therapy.  The PCR results from cerebrospinal fluid (CSF) vary and the overall sensitivity in CSF does not exceed 20%, therefore, a negative result in the CSF does not rule out LD.  Urine has been shown not to be a good sample choice for diagnosis as the results showed large variations.  In conclusion, the most important element in LD diagnosis is the clinical picture and patient history supported by laboratory testing using several methods to improve sensitivity.  It is highly recommended that PCR testing be performed as early as possible following a possible exposure to ticks.  If the results are positive, prophylactic treatment can be recommended by a clinician and other testing is performed to monitor the treatment efficacy.

Clongen Laboratories offer Lyme Disease Testing by Western Blot.  The test detects both IgM and IgG supports the PCR results.  The IgM Western Blot is especially helpful in detecting the acute stage of B. burgdorferi infection while the IgG Western Blot is useful after a month or more have passed since exposure to a Lyme disease-infected tick. 

To learn more about Lyme Disease Symptoms, Treatment and other related information, please visit helpful links on our website at http://www.clongen.com/Helpful%20Links.htm

 

We are currently offering

1.  PCR testing for LD (CPT code 550012)  (whole blood or tick removed from skin)

2.  Western Blot Analysis on serum samples

3.  Culture in microbiological enriched media. 

Please contact us for instructions on sample collection or shipping instructions (877-CLONGEN).

Suggested samples for Lyme Disease Testing:

1.  Synovial Fluid from affected joints. (Shipped Frozen)

2.  Cerebrospinal Fluid. (Shipped Frozen)

3.  Blood collected in either EDTA or Citrate Tubes. (Shipped at room temperature or cooled on blue ice in the summer).

4.  Actual tick removed from bite size.

Description

Test#

Turnaround

Lyme Disease (Borrelia burgdorferi) - Multiplex PCR for simultaneous detection of two gene targets in Borrelia burgdorferi (ultrasensitive method)

124

1-3 days

Lyme Disease (Borrelia burgdorferi) - Western Blot Analysis
124A

3-5 days

Lyme disease by PCR and Western Blot Panel
124B 3-5 days
Tick Testing for Lyme Disease (Borrelia burgdorferi) - Multiplex PCR for simultaneous detection of two gene targets in Borrelia burgdorferi (ultrasensitive method)
124C 1-3 days

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clongen Laboratories, LLC ·  12321 Middlebrook Road, Suite 120  ·  Germantown, MD 20874   · Phone: (301) 916-0173  ·  Fax: (301) 916-0175   ·

 Toll Free (877) CLONGEN (256-6436)  ·  E-mail: cs@clongen.com

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