Lyme Disease, Screening with Reflex to Confirmation

Introduction

Borrelia burgdorferi is the bacteria that causes Lyme disease. B. burgdorferi is transmitted by black-legged ticks that are commonly found on vegetation and animals such deer, dogs, mice, horses, and birds in endemic areas.

When a person is bitten by a tick carrying B. burgdorferi, the bacteria can enter the body through the skin, often causing a characteristic rash, fever, headache, and fatigue. Untreated Lyme disease can spread throughout the body, affecting the joints, heart, and nervous system. Generally, Lyme disease is effectively treated with a few weeks of antibiotics.

When Lyme disease occurs, the body’s immune system produces antibodies that are specific to B. burgdorferi. IgM antibodies are produced within the first few weeks, followed by the production of IgG antibodies. This test detects IgM and IgG antibodies towards the VlsE1 and pepC10 antigens from B. burgdorferi in an initial screening test. Any preliminary positive or equivocal results from the initial screening test are then confirmed with additional testing following modified two-tier test methodology.

Pricing

$89

How to order a test

Synonyms

• Lyme Disease Test
• Borrelia burgdorferi Antibody Test

What is Included?

Detection of IgM and IgG antibodies towards the VlsE1 and pepC10 antigens from B. burgdorferi in an initial screening test. Any preliminary positive or equivocal results from the initial screening test are then confirmed with additional testing following modified two-tier test methodology.

Turnaround Time

1 – 3 business days
The turnaround time is not guaranteed. The average turnaround time is 1 – 3 business days from the date that the sample arrives at the laboratory. Shipping time for the sample is not included. Additional time is required if the case requires confirmatory or reflex testing, or if the sample is insufficient, or if a recollection is required.

Related Documents

Additional Information and Resources

Preparation Before Specimen Collection

None

Specimen Type

Blood

Volume

50 μL in a microtainer

Container

Microtainer (regular blood tube)

Collection Method

This test requires a blood sample from a finger prick. All supplies for sample collection are provided in the kit.

1. First wash and dry hands. Warm hands aid in blood collection.
2. Clean the finger prick site with the alcohol swab and allow to air dry.
3. Use the provided lancet to puncture the skin in one quick, continuous and deliberate stroke.
4. Wipe away the first drop of blood.
5. Massage hand and finger to increase blood flow to the puncture site. Angle arm and hand downwards to facilitate blood collection on the fingertip.
6. Drip blood into the microtainer tube.
7. Dispose of all sharps safely and return sample to the laboratory in the provided prepaid return shipping envelope.

NOTES: Avoid squeezing or ‘milking’ the finger excessively. If more blood is required and blood flow stops, perform a second skin puncture on another finger. Do not touch the fingertip.

Specimen Storage

Maintain specimen at temperatures between 2°C and 30°C during storage and transport.

Specimen Stability

Blood samples can be refrigerated or kept at room temperature for up to 7 days.

Causes for Rejection

• Incorrect or incomplete patient identification
• Incorrect specimen collection
• Inappropriate storage and transport conditions
• Incorrect specimen volume

Purpose

To aid in the diagnosis of Lyme disease.

Limitations

• This report is not intended for use in medico-legal applications.
• These results should be interpreted in conjunction with other laboratory and clinical information.
• Correct specimen collection and handling is required for optimal assay performance.
• False-negative and false-positive Lyme disease test results are common. In particular, an infected person may receive a negative test result in the first eight weeks after the tick bite, as their body has not produced enough antibodies to be detectable in laboratory assays. Early antibiotic therapy can also prevent an antibody response and result in a false-negative. Antibodies to B. burgdorferi can persist in the blood for months or even years after an infection is cured, so a positive result may be from a previous infection or false-positive results can occur due to other bacterial, viral, or autoimmune diseases.

Methodology

Screening: ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System.

Confirmation: ZEUS IFA Borrelia burgdorferi IgG/IgM Test System.

Reference Interval

Negative: No significant amount of antibodies to B. burgdorferi detected in the sample tested.