INTENDED USE
The Brucella IgG/IgM Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of the IgG and IgM antibodies to the Lipopolysaccharide (LPS) of Brucella in human whole blood, serum or plasma specimen.
TEST 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 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.
PERFORMANCE CHARACTERIST
Clinical Sensitivity, Specificity and Accuracy
The Brucella IgG/IgM Antibody Rapid Test has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Brucella PCR kit.
Brucella IgG/IgM Antibody Rapid Test vs. PCR kit
| Brucella Infection |
Result |
IgM |
IgG |
| Primary Infection |
Positive |
32 |
1 |
| Negative |
4 |
35 |
| Total |
36 |
36 |
| Relative Sensitivity |
88.9% |
2.8% |
| Secondary Infection |
Positive |
33 |
50 |
| Negative |
17 |
0 |
| Total |
50 |
50 |
| Relative Sensitivity |
66.0% |
>99.0% |
| Non-Brucella Infection |
Positive |
0 |
0 |
| Negative |
270 |
270 |
| Total |
270 |
270 |
| Relative Specificity |
>99.0% |
>99.0% |
For the primary and secondary infection, the overall sensitivity is IgM 75.6%, IgG 59.3%, the overall specificity is IgM >99.0%, IgG IgM >99.0% and the overall accuracy is IgM 94.1%, IgG 90.2%.
Precision
Intra-Assay
Within-run precision has been determined by using 10 replicates of four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. Three different lots of the Brucella IgG/IgM Antibody Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.
COMPANY PROFILE
Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.
1. Easy opertaion
2. Fast read Result: (10-15minutes)
3. High Sensitivity and accuracy
4. Reasonable price and high quality
5. Top customer service
6. Professional after-sales service
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