Sample
Serum, plasma or cerebrospinal fluid (CSF)
Intended Use
The Mycobacterium tuberculosis IgG ELISA is an in-vitro diagnostic microtiter plate based Enzyme assay for the quantitative detection of human IgG antibodies to Mycobacterium tuberculosis in serum, plasma or cerebrospinal fluid (CSF) within 100 minutes.
This test is intended to support the diagnosis of active tuberculosis (TB) and is not suitable for contact screening of populations.
Contents of Kit
1 microtiter plate (96 wells) with 12 x 8 breakable strips suitable for 43 samples (duplicate measurements), including liquids: sample diluent, wash buffer, 4 standard solutions, conjugate solution, substrate solution and stop-solution.
Test Components
1.IVD In-Vitro Diagnostic Medical Device
2.PL Microtiter plate (96 wells), ready-to-use, coated with Mycobacterium tuberculosis antigens (12 x 8 individual breakable strips) sealed in an aluminum pouch with a desiccant bag.
3.PV Sample Diluent: 100 mL, ready-to-use, in PE-vial, PBS/BSA buffer, contains 0.05% 5-bromo-5-nitro-1.3-dioxane.
4.WP Wash Buffer, 10 x concentrate: 60 mL, in PE-vial, PBS buffer with Tween 20, contains 0.05% 5-bromo-5-nitro-1.3-dioxane.
5.STA1-4 4 standard solutions: 2 mL each, readyto-use, in PE-vials, with different amounts of relevant specific antibodies against Mycobacterium tuberculosis, contains 0.05% 5-bromo-5-nitro-1.3-dioxane.
6.CON Anti-human-IgG-conjugate solution: 12 mL, ready-to-use, in PE-vial, contains 0.05% 5-bromo-5-nitro-1.3-dioxane.
7.TMB TMB substrate solution: 12 mL, ready-touse, in PE-vial (black), contains a solution of tetramethylbenzidine (TMB).
8.STO Stop-solution: 12 mL, ready-to-use, in PE-vial, 0.2 M H2SO4.
9.1 instruction for use.
10.Plastic bag: Reseal-able, for the dry storage of unused microtiter plate/strips.
Storage
Store the test at 2 - 8°C. Unopened kit components are stable until the expiry date. The expiry date is printed on the labels of the aluminum pouch (microtiter plate), on the labels of the containers for the liquids and on the outer packaging.
Do not use if the aluminum pouch is damaged. DO NOT FREEZE or expose temperatures above 30°C (except wash buffer, if crystal precipitate occurs).
Aluminum pouch with microtiter plate: Keep the test in unopened aluminum bag at 2 - 8°C.
Opened aluminum pouch with microtiter plate: Use up microtiter plate within 6 months!
Liquids: Keep liquid components at 2 - 8°C. Unopened liquids are stable until the expiry date. After first opening the liquids are stable for 6 months, if the bottles are tightly closed after every usage.
Precision
The intra-assay coefficient of variation (CV) of Human Tuberculosis Test kits (TUB ELISA) was determined by ten-fold repeated measurements of several positive samples. The intra-assay CV is less than 10%.
General Description
Human tuberculosis (TB) has become a global disease with its re-emergence in the Western countries in the last decades. According to WHO, more than 30 % of the world's population is estimated to be infected with the TB bacterium, Mycobacterium tuberculosis. TB is predominantly a disease of the respiratory tract, but can also affect other organs. People who are suffering from active pulmonary tuberculosis are highly infectious. TB kills yearly about 2 million people. Although, the TB bacterium was identified more than 100 years ago, the diagnostic methods, which are currently available, suffer from high price, poor sensitivity and specificity and are time consuming. The diagnosis of TB is usually made based on a combination of several laboratory tests.
The Mycobacterium tuberculosis IgG ELISA is suitable for the quantitative detection of human IgG antibodies to Mycobacterium tuberculosis within 100 minutes. This test is an additional tool for rapid diagnosis of active tuberculosis (TB) using small amount of clinical sample.
Citations
Publication ()
Have you cited DEIA1926 in a publication?
Let us know and earn a reward for your research.
COA
Loading ......
