The LifeSign Status H. Pylori Test Control Set estimates the precision and monitors the accuracy of the H. Pylori test procedure. The use of these controls is intended for in vitro diagnostic use and can be easily performed in an office setting, without the need for a high-end lab.The set includes a bottle of positive control and a bottle of negative control liquid. The dropper bottles allow easy dispensing and prevent spillage or wastage. The controls need to be stored at low temperatures of 2 – 8 but they have a long shelf life of 22 months.
- CLIA WAIVED for whole blood
- Fingerstick whole blood convenience
- Requires only 25 ?l of whole blood or 10 ?l serum/plasma
- Single-reagent procedure
- Results available in 10 minutes
- Sensitivity of 95.9% with 91.6% overall agreement to biopsy histology
