Brucella Igg/Igm Antibody Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HBRU039T
• Blood Sampling Needle: None
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

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.
MATERIALS
Materials Provided

Individually packed test devices Disposable pipettes

Package insert Buffer

Materials Required but Not provided

Specimen collection container Centrifuge Micropipette

Timer Lancets

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.

1. 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.