| Species : |
Human |
| Usage : |
The material can be used for intra-laboratory quality-control of the measurement procedure, to verify the comparability of the results from different laboratories using this measurement procedure or for calibration. To compare an analytical result with the certified value, see ERM Application Note 1; www.erm-crm.org. If the material is used for calibration ot In-Vitro Diagnostic devices, the commutability of the material has to be assessed by the user and the uncertainty of the certified value shall be taken into consideration in the final estimation of measurement uncertainty. To make it ready for use, the material has to be reconstituted according to the following procedure.1. Take the ampoule out of the refrigerator and allow to equilibrate at room temperature.2. Tap the vertically positioned ampoule gently to ensure that the lyophilised material is at the bottom of the ampoule.3. Score the ampoule at the constriction with a sharp file and open, by applying a red hot glass rod to the score for about 1 s, while holding the ampoule almost horizontally to prevent glass from entering the ampoule. 4. Reconstitution by slow addition to the sides of the ampoule (1.00±0.01) mL distilled water at room temperature from a calibrated glass pipette or a dispenser of equivalent accuracy. 5. Seal the ampoule with an inert plastic film and allow to stand for 2 minutes. Vortex-mix for 2 s and keep cold (0-4 oC) for not less than 58 minutes.6. Vortex-mix (2 s), keep at 4 oC. Complete the analysis within 4 h, i.e. between 1 and 5 h from the start of the reconstitution.The ampoule should not be stored for re-use. It is no intended that a portion of the lyophilised material be removed for reconstitution. |
| Quality Control Test : |
The catalytic concentration of the enzyme was measured using 4-nitrophenyl phosphate as substrate at 37 °C and subsequent detection by spectrophotometry (method specified in detail in the report). |
| Notes : |
The product must be handled with adequate care as any material of human origin. Human prostatic acid phosphatase has been extracted from non-cancerous human prostatic tissue. The prostatic extract was negative on testing for HIV 1 antibodies and Hepatitis B surface antigen. The material is intended for laboratory use only and the usual laboratory safety precautions apply. |
| Storage : |
Upon arrival the material shall be stored at -20 °C, for no more than 12 months until use. However, the European Commission cannot be held responsible for changes that happen during storage of the material at the customer's premises, especially of opened samples. |
| Concentration : |
Prostatic acid phosphatase: 0.466 ukat/L; 28.0 U/L |
