Leptospira IgG/IgM Rapid Test

INTENDED USE

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

INTRODUCTION

Leptospirosis is a bacterial disease that affects humans and animals. It is caused by bacteria of the genus Leptospira. The bacteria are spread through the urine of infected animals, which can get into water or soil and can survive there for weeks to months. The bacteria that cause leptospirosis are spread through the urine of infected animals, which can get into water or soil and can survive there for weeks to months. Many different kinds of wild and domestic animals carry the bacterium.Many different kinds of wild and domestic animals carry the bacterium. In humans, Leptospirosis can cause a wide range of symptoms with fever, chills, headache, muscle aches, vomiting or diarrhea at the first phase. Kidney or liver failure or meningitis may occur at a second phase. The illness lasts from a few days to 3 weeks or longer. The disease occurs worldwide but is most common in temperate or tropical climates. It is an occupational hazard for people who work outdoors or with animals.    

The Leptospira IgG/IgM Rapid Test is a rapid test that utilizes a combination of Leptospira antigen coated colored particles for the detection of IgG and IgM to L. Donovani 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