Contents of Kit
1. Microtiterwells, 12 x 8 (break apart) strips, 96 wells; Wells coated with RSV antigen. (incl. 1 strip holder and 1 cover foil)
2. Sample Diluent*, 1 vial,100 mL, ready to use, colored yellow; pH 7.2±0.2.
3. Pos.Control*, 1 vial, 1.0 mL, ready to use;
4. Neg. Control*, 1 vial, 2.0 mL, ready to use; colored yellow, yellow cap.
5. Cut-off Control*, 1 vial, 2.0 mL, ready to use; colored yellow, black cap.
6. Enzyme Conjugate*, 1 vial, 20 mL, ready to use, colored red, antibody to human IgG conjugated to horseradish peroxidase.
7. Substrate Solution, 1 vial, 14 mL, ready to use, Tetramethylbenzidine (TMB).
8. Stop Solution, 1 vial, 14 mL, ready to use,contains 0.2 mol/L H2SO4. Avoid contact with the stop solution. It may cause skin irritations and burns.
9. Wash Solution*, 1 vial, 30 mL (20x concentrated for 600 mL), pH 6.5±0.1, see "Preparation of Reagents".
* : Contain non-mercury preservative.
Storage
1. When stored at 2°C to 8°C unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.
2. Opened reagents must be stored at 2°C to 8°C.
3. Microtiter wells must be stored at 2 °C to 8 °C.
4. Once the foil bag has been opened, care should be taken to close it tightly again.
5. Opened kits retain activity for two months if stored as described above.
Performance Characteristics
Diagnostic Specificity
The diagnostic specificity is defined as the probability of the assay of scoring negative in the absence of the specific analyte. lt is 100 %.
Diagnostic Sensitivity
The diagnostic sensitivity is defined as the probability of the assay of scoring positive in the presence of the specific analyte. lt is 100 %.