Interfering Substances Sample Clauses

Interfering Substances. BGM Galectin-3 was evaluated for the effects of potential interfering substances, both endogenous and exogenous, according to the recommendations of the CLSI EP7-A guideline, using an interference acceptance limit of +/-10%. Conjugated bilirubin (up to 16.8 mg/dL), unconjugated bilirubin (up to 40.3 mg/dL), albumin (BSA, up to 12 g/dL), triglycerides (up to 3000 mg/dL), cholesterol (up to 747 mg/dL), and creatinine (up to 5 mg/dL) do not show any significant interference in the assay based on the interference acceptance limit (+/- 10%). Purified hemoglobin (up to 500 mg/dL) does not show significant interference in BGM Galectin-3; however, packed blood cell lysate does show interference. Human anti-mouse antibodies (HAMA) and rheumatoid factor (RF) cause significant positive interference and rheumatoid factor (RF) greater than 50 IU/mL causes significant BG Medicine, Inc., ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Document: LAB-IVD-001 R07 Tel: (+▇) ▇▇▇.▇▇▇.▇▇▇▇, Fax: (+▇) ▇▇▇.▇▇▇.▇▇▇▇ Effective: 09Mar11 Portions of this Exhibit, indicated by the ▇▇▇▇ “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. positive interference with BGM Galectin-3. High levels of gamma globulins (> 2.5 g/dL) may cause false elevation in galectin-3 levels. This information is summarized in Table 16. BG Medicine, Inc., ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Document: LAB-IVD-001 R07 Tel: (+▇) ▇▇▇.▇▇▇.▇▇▇▇, Fax: (+▇) ▇▇▇.▇▇▇.▇▇▇▇ Effective: 09Mar11 Portions of this Exhibit, indicated by the ▇▇▇▇ “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Interfering Substances. Ingestion of ascorbic acid (Vitamin C) in high doses has been shown to cause false negative results, and intake should be discontinued 2 days prior to, and during, the test period.7 Peroxidase from fruit and vegetables can cause false positive results.8-11 Elimination of red meat from the diet during the test period eliminates the source of hemoglobin which can cause false positive results. Oral medications (such as aspirin, indomethacin, reserpine, phenalbutazone, corticosteroids, etc.) and heavy alcohol consumption may cause irritation or bleeding of the gastrointestinal tract and should be discontinued for 7 days prior to and during the test period.

Interfering Substances. Hemolysis: Erythrocytes contain 100-150 times more LD than does serum. Hemolysis may contribute to error in assessment of LD1,2 activity.1-2,11