| Species : |
Human |
| Usage : |
The total contents of the ampoule should be reconstituted at room temperature with 1 ml distilled water, dissolved by gentle swirling to avoid froth and transferred immediately to a suitable plastic tube. No attempt should be made to weigh out any portion of the freeze-dried material. Although studies have shown the reconstituted standard to be stable for up to 3 hours when kept on melting ice, it is recommended that assays of FVIII:C be carried out as soon as possible after reconstitution. When using this standard to calibrate other concentrates, both standard and test concentrates MUST be pre-diluted in FVIII deficient plasma, either haemophilic plasma, or artificially depleted plasma containing normal levels of VWF, before making the assay dilutions. Assay dilution buffers should contain 1% albumin, preferably clinical grade. |
| Notes : |
This preparation is not for administration to humans. The preparation contains material of human origin, and either the final product or the source materials, from which it is derived, have been tested and found negative for HBsAg, anti-HIV and HCV RNA. The concentrate standard was prepared from pooled therapeutic concentrates which were manufactured from pools of human plasma in which every donation as well as the pools were tested and found negative for HBsAg, anti-HIV 1 & 2, and anti-hepatitis C antibodies; in addition, the plasma pools were tested and found negative for hepatitis C RNA (NAT testing). The therapeutic concentrates had also undergone a virus inactivation procedure. The concentrate standard contains human albumin, clinical grade, which was also prepared from pools of human plasma in which every donation was tested and found negative for HBsAg, anti-HIV 1 and 2, and anti-hepatitis C antibodies. As with all materials of biological origin, this preparation should be regarded as potentially hazardous to health. It should be used and discarded according to your own laboratorys safety procedures. Such safety procedures should include the wearing of protective gloves and avoiding the generation of aerosols. Care should be exercised in opening ampoules or vials, to avoid cuts. |
| Stability : |
Reference materials are held at Creative Biomart within assured, temperature- controlled storage facilities. Reference Materials should be stored on receipt as indicated on the label. Accelerated degradation studies have shown that this standard is extremely stable both when stored at -20°C and at mailing temperatures. Predicted loss of FVIII activity when stored at -20°C was below 0.01% per year. |
| Storage : |
Unopened ampoules should be stored at -20°C. After reconstitution, any unused material must be discarded, not frozen for later use. Please note: because of the inherent stability of lyophilized material, Creative Biomart may ship these materials at ambient temperature. |
