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A company specializing in the development, production and sales of in vitro diagnostic products.
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E-mail:
info@immuno-test.com
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Building 1, 578 No.20 Street, Qiantang District, Hangzhou City, Zhejiang Province
Lyme Borrelia IgG/IgM Rapid Test
Phone:0571-85368996 | Email:info@immuno-test.com
Abbr.:
Specification:
Specimen:
Assay Time:
Model No.:
HLYM077T
Model No.: HLYM077T
Assay Time: 10-15 minutes
Specimen: Whole Blood,serum or plasma
Lyme Borrelia IgG/IgM Rapid Test
Graphic Details
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.
| [Assay Time] | 10-15 minutes |
| [Specimen] |
whole blood, serum or plasma specimen. |
| [Storage Temperature] | 2-30℃, DO NOT FREEZE |
| [Usage] | For the detection of IgG and IgM to Borrelia spp. antibodies in human whole blood, serum, or plasma. |
| [Packing] | 20 tests/box |
| [Materials Provided] | Individually packed test devices |
| Buffer |
|
| Disposable pipettes |
|
|
Package insert |
PRINCIPLE
The Lyme Borrelia IgG/IgM Rapid Test is a qualitative membrane - based immunoassay for the detection of Borrelia antibodies in whole blood, serum, or plasma.
PROCEDURE
Allow the test device, specimen, buffer, and/or controls to reach room temperature (15 - 30°C) prior to testing.
1. 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 μL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 μL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens:
1) 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 μL) and start the timer. See illustration below.
2) 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
IgG POSITIVE: The colored line in the control line region (C) appears, and a colored line appears in test line region G The result is positive for Borrelia specific-IgG and is probably indicative of secondary Borrelia infection.
IgM POSITIVE: The colored line in the control line region (C) appears, and a colored line appears in test line region M. The result is positive for Borrelia specific-IgM antibodies and is indicative of primary Borrelia infection.
IgG AND IgM POSITIVE: The colored line in the control line region (C) appears, and two colored lines should appear in test line regions G and M. The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary Borrelia infection.
NEGATIVE: Only one colored band appears, in the control region (C). No line appears in test line regions G or M.
INVALID: No Control line (C) appears.
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