T. Cruzi IgG ELISA Kit

Sample

Serum or plasma

Species Reactivity

Human

Detection Method

ELISA

Intended Use

An enzyme immunoassay (ELISA) kit for the qualitative and semiqualitative detection of IgG antibodies antiTrypanossoma cruzi in human serum or plasma (citrate, heparin) using recombinant antigen.

Contents of Kit

1. MTP Microtiter Plate: 12 break-apart 8-well snap-off strips coated with recombinant Trypanosoma cruzi antigens; in resealable aluminium foil.
2. ENZCONJ Enzyme Conjugate: 1 bottle containing 20 mL of peroxidase labelled Protein A in phosphate buffer (10 mM); coloured blue; ready to use; black cap.
3. CONTROL + Positive Control: 1 vial containing 2 mL control; coloured yellow; ready to use; red cap; ≤ 0.02 % (v/v) MIT.
4. CONTROL - Negative Control: 1 vial containing 2 mL control; coloured yellow; ready to use; blue cap; ≤ 0.0015 % (v/v) CMIT/ MIT (3:1).
5. CONTROL CO Cut-off Control: 1 vial containing 3 mL control; coloured yellow; ready to use; green cap; ≤ 0.02 % (v/v) MIT.
6. SAMPLEDIL Sample Diluent: 1 bottle containing 100 mL of phosphate buffer (10 mM) for sample dilution; pH 7.2 ± 0.2; coloured yellow; ready to use; white cap; ≤ 0.0015 % (v/v) CMIT/ MIT (3:1).
7. TMB SUBS TMB Substrate Solution: 1 bottle containing 15 mL 3,3',5,5'-tetramethylbenzidine (TMB), < 0.1 %; ready to use; yellow cap.
8. WASHBUF CONC Wash Solution (20x conc) : 1 bottle containing 50 mL of a 20-fold concentrated phosphate buffer (0.2 M), pH 7.2 ± 0.2, for washing the wells; white cap; 0.2 % (w/v) 5-Bromo-5-nitro-1,3-dioxane.
9. TMB STOP Stop Solution: 1 bottle containing 15 mL sulphuric acid, 0.2 mol/L; ready to use; red cap.

Storage

Store the kit at 2° - 8°C. The opened reagents are stable up to the expiry date stated on the label when stored at 2° - 8°C.

Performance Characteristics

The specificity is defined as the probability of the assay of scoring negative in the absence of the specific analyte. It is 100 % (95 % confidence interval: 93.02 % - 100 %).
The sensitivity is defined as the probability of the assay of scoring positive in the presence of the specific analyte. It is 100 % (95 % confidence interval: 95.44 % - 100 %).
Cross reaction of the antigens with antibodies against Leishmania, Malaria, Trypanosoma brucei cannot be excluded.

General Notes

An enzyme immunoassay (ELISA) kit for the qualitative and semiqualitative detection of IgG antibodies antiTrypanossoma cruzi in human serum or plasma (citrate, heparin) using recombinant antigen.