Intended Use
The Trichinella spiralis IgG ELISA is intended for the qualitative determination of IgG class antibodies against Trichinella spiralis in human serum or plasma (citrate, heparin).
Contents of Kit
1. Microtiterplate: 12 break-apart 8-well snap-off strips coated with Trichinella spiralis antigens; in resealable aluminium foil.
2. DIL : 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).
3. SOLN│STOP : 1 bottle containing 15 mL sulphuric acid, 0.2 mol/L; ready to use; red cap.
4. WASH│BUF│20x : 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.
5. Conjugate: 1 bottle containing 20 mL of peroxidase labelled Protein A in phosphate buffer (10 mM); coloured blue; ready to use; black cap.
6. SUB│TMB : 1 bottle containing 15 mL 3,3',5,5'-tetramethylbenzidine (TMB), < 0.1 %; ready to use; yellow cap.
7. Positive Control: 1 vial containing 2 mL control; coloured yellow; ready to use; red cap; ≤ 0.02% (v/v) MIT.
8. Cut-off Control: 1 vial containing 3 mL control; coloured yellow; ready to use; green cap; ≤ 0.02% (v/v) MIT.
9. Negative Control: 1 vial containing 2 mL control; coloured yellow; ready to use; blue cap; ≤ 0.0015% (v/v) CMIT/ MIT (3:1).
10. 1 Cover foil
11. 1 Instructions for use (IFU)
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.
Sensitivity
It is 100% (95% confidence interval: 79.41% - 100%).
General Notes
The Trichinella spiralis IgG ELISA is intended for the qualitative determination of IgG class antibodies against Trichinella spiralis in human serum or plasma (citrate, heparin).
Citations
Publication ()
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