Sample
Serum, Plasma and Cerebrospinal Fluid.
Intended Use
The TUB 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), ready-to-use, coated with Mycobacterium tuberculosis antigens.
2. Sample Diluent: 100 ml, ready-to-use, in PE-vial, PBS/BSA buffer, contains 0.05% 5-bromo-5-nitro-1.3-dioxane.
3. Wash Buffer, 10 × concentrate: 60 ml, in PE-vial, PBS buffer with Tween 20, contains 0.05% 5-bromo-5-nitro-1.3-dioxane.
4. 4 Standard Solutions: 2 ml each, ready-to-use, in PE-vials, with different amounts of relevant specific antibodies against Mycobacterium tuberculosis, contains 0.05% 5-bromo-5-nitro-1.3-dioxane.
5. Anti-Human-IgG-Conjugate Solution: 12 ml, ready-to-use, in PE-vial, contains 0.05% 5-bromo-5-nitro-1.3-dioxane.
6. TMB substrate solution: 12 ml, ready-touse, in PE-vial (black), contains a solution of tetramethylbenzidine (TMB).
7. Stop-Solution: 12 ml, ready-to-use, in PE-vial, 0.2 M H2SO4.
8. 1 Instructions for use.
9. Plastic Bag: Reseal-able, for the dry storage of unused microtiter plate/strips.
Storage
1. 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.
2. 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).
3. Aluminum pouch with microtiter plate: Keep the test in unopened aluminum bag at 2-8°C.
4. Opened aluminum pouch with microtiter plate: Use upmicrotiter plate within 6 months!
5. 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.
Performance Characteristics
Diagnostic sensitivity and specificity for serum/plasma: 1. To determine the diagnostic sensitivity and specificity 1193 serum and plasma samples from different regions were evaluated with the TUB IgG ELISA. The results of the TUB IgG ELISA were compared with clinical outcomes.
2. As gold standard for the diagnosis of "TB", a pathogen detection based on cultivation was defined (Positive control group, a total number of 578 samples). As "Negative control", samples of clinically healthy donors and patients with other diseases were measured (615 samples).
3. Extensive studies on samples of TB patients (culture positive) showed a sensitivity of 67.82% and a specificity of 96.91%. The cumulative sensitivity could be additionally increased by simultaneous measurement of IgG and IgA antibodies.
4. The Positive predictive value (PPV) was 0.9537 with a Negative predictive value (NPV) of 0.7621.
Diagnostic sensitivity and specificity for CSF:1. To determine the diagnostic sensitivity and specificity 156 CSF samples were evaluated with the TUB IgG ELISA.
2. As Positive control group samples of patients with proven TB meningitis were used (total number of 19 samples). As "Negative control" other causes for meningitis or other neurological diseases were used (total number of 137 samples).
3. For TB meningitis, a clinical sensitivity of 47.4% and a specificity of 93.7% were determined.
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 TUB 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 DEIA381 in a publication?
Let us know and earn a reward for your research.
COA
Loading ......
