Due to depletion of the coating antibody used in the current Testosterone Saliva ELISA Kit, a design change was performed to produce a kit with a new coating antibody.
The new Testosterone Saliva ELISA Kit will replace the current kit on the implementation date of July 01, 2022, at which time the current Testosterone Saliva ELISA Kit will no longer be available.
Prior to the implementation date, the new Testosterone Saliva ELISA Kit will be available for evaluation purposes (research use only) and will have catalogue number CAN-TE-300 (DC). On the implementation date, the new Testosterone Saliva ELISA kit will revert to catalogue number CAN-TE-300 and retain the same regulatory approvals as the current kit.
A comparison study was performed between the new (y) and a competitor (x) Testosterone Saliva ELISA kits using 104 samples. The following linear regression (Passing-Bablok fit) was obtained:
y = 0.79x – 1.9, r = 0.97
A second comparison study was performed between the new Testosterone Saliva ELISA kit (y) and another competitor’s ELISA kit (x) using 46 samples. The following linear regression (Passing-Bablok fit) was obtained:
y = 0.96x – 0.1, r = 0.76
The main changes between the current and new Testosterone Saliva ELISA kits are as summarized in the following table:
| Parameter | Current Testosterone Saliva ELISA | New Testosterone Saliva ELISA |
|---|---|---|
| Reagents Provided | ||
| Conjugate Format | Two Conjugates in Concentrated form: Testosterone-Biotin and Streptavidin-HRP | One Conjugate in Ready To Use form: Testosterone-HRP conjugate |
| Conjugate Volume | 0.3 mL (Biotin) and 0.4 mL (Streptavidin) | 15 mL |
| Calibrator Concentrations | 0, 2, 10, 50, 200, 800 pg/mL | 0, 10, 40, 120, 360, 1000 pg/mL |
| Assay Buffer | Two assay buffers: Biotin Conjugate Assay Buffer and HRP Conjugate Assay Buffer | None (not required) |
| Assay Procedure | ||
| Specimen Pretreatment | Centrifugation and heating at 60–70°C for 1 hour | Freeze, thaw and centrifugation |
| Number of Steps | 13 | 11 |
| Conjugate Volume/Well | 100 μL (Biotin) and 150 μL (Streptavidin) | 100 μL |
| Total Incubation Time | 105 minutes | 90 minutes |
| Washing Steps | 2 separate wash steps, each 5 x 300 μL/well | 1 wash step, 3 x 350 μL/well |
| Performance Characteristics | ||
| The performance characteristics have been updated with the new kit. The main advantages of the new kit are listed below. | ||
| Sensitivity | The sensitivity study was performed according to the CLSI EP17-A2 guideline. | |
| Precision | The precision study was performed based on the CLSI EP05-A3 guideline. | |
| Linearity | The linearity study was performed according to the CLSI EP06-A guideline. | |
| Reference Ranges | The reference ranges of the new (DC) kit match closely to those of the current kit. | |