Lyme Antibody Rapid Test

INTENDED USE

The Lyme Borrelia IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Borrelia spp. in human whole blood, serum or plasma specimen.

INTRODUCTION

Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by bacteria of the Borrelia spp. which is spread by ticks. The most common sign of infection is an expanding area of redness on the skin, known as erythema migrans, that begins at the site of a tick bite about a week after it has occurred.1 The rash is typically neither itchy nor painful. Approximately 25-50% of infected people do not develop a rash. Other early symptoms may include fever, headache and feeling tired. If untreated, symptoms may include loss of the ability to move one or both sides of the face, joint pains, severe headaches with neck stiffness, or heart palpitations, among others. Months to years later, repeated episodes of joint pain and swelling may occur. Occasionally, people develop shooting pains or tingling in their arms and legs. Despite appropriate treatment, about 10 to 20% of people develop joint pains, memory problems, and feel tired for at least six months.

Lyme disease is transmitted to humans by the bite of infected ticks of the genus Ixodes. Usually, the tick must be attached for 36 to 48 hours before the bacteria can spread. In North America, Borrelia burgdorferi and Borrelia mayonii are the causes. In Europe and Asia, the bacteria Borrelia afzelii and Borrelia garinii are also causes of the disease. The disease does not appear to be transmissible between people, by other animals, or through food. Diagnosis is based upon a combination of symptoms, history of tick exposure, and possibly testing for specific antibodies in the blood.  Blood tests are often negative in the early stages of the disease. Testing of individual ticks is not typically useful.The Lyme Borrelia IgG/IgM Rapid Test is a rapid test that utilizes a combination of Borrelia antigen coated colored particles for the detection of IgG and IgM to Borrelia spp. antibodies in human whole blood, serum, or plasma.

PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens: 

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 uL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 2 drops of whole blood (approximately 20 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.

To use a micropipette: Pipette and dispense 20 µL of whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 µL) and start the timer.

3. Wait for the colored line(s) to appear. Read results at 10 minutes.Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS