Tuberculosis Igg/Igm Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HTB068T
• 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 Tuberculosis IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Tuberculosis virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Tuberculosis infections.

SUMMAR
MATERIALS

Materials Provided

Individually packed test devices Disposable pipettes

Package insert Buffer

Materials Required but Not provided

Specimen collection container Centrifuge Micropipette

Timer Lancets

TEST 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 5μl), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90μl) 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 1 drop of whole blood (approximately 10μl) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90μl) and start the timer. See illustration below.
To use a micropipette: Pipette and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90μl) 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.

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 Tuberculosis virus specific-IgG and is probably indicative of secondary Tuberculosis 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 Tuberculosis virus specific-IgM antibodies and is indicative of primary Tuberculosis 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 Tuberculosis infection.
NOTE: The intensity of the color in the test line region(s) (G and/or M) will vary depending on the concentration of Tuberculosis antibodies in the specimen. Therefore, any shade of color in the test line region(s) (G and/or M) should be considered positive.
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. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
 

PERFORMANCE CHARACTERIST

Clinical Sensitivity, Specificity and Accuracy

The Tuberculosis IgG/IgM Rapid Test has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Tuberculosis PCR kit.


 Tuberculosis IgG/IgM Rapid Test vs. PCR kit

Tuberculosis Infection	Result	IgM	IgG
Tuberculosis Infection	Positive	98	101
	Negative	7	5
	Total	105	106
	Relative Sensitivity	93.33%	95.28%

Cross-Reactivity
An evaluation was performed to determine the cross reactivity of Tuberculosis IgG/IgM Rapid Test. No cross reactivity against gastrointestinal pathogens occasionally present as following:

Anti-HIV	Pulmonary diseases	Rheumatoid factor (RF)
Anti-CMV	Anti-HCV

Detection Of Limit
The results show that the minimum detection limit of Tuberculosis IgG was 128 times dilution. The minimum detection limit for Tuberculosis IgM is 256 times dilution.
Hook Effect
The present test results show that the hook effect of Tuberculosis IgG is 128 times higher and that of Tuberculosis IgM is 256 times higher.

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 Tuberculosis IgG/IgM Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.