One Step Tuberculosis Igg/Igm Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: /
• Model NO.: HTB068T
• Blood Sampling Needle: /
• Breathing Pattern: /
• Animal Anesthesia Machine Control Method: /
• Assay Time: 10-15 Minutes
• Specimen: Wholeblood, Serum, or Plasma
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Support
• Storage Temperature: 2-30°c
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

Introduction

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

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 possibl

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.

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 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.
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.

PERFORMANCE

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%

 

Company Profile

 

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.

 

 

Certifications

CERTIFICATION

 

Packaging & Shipping