Method: Colorimetric

Matrix: Menstrual blood of feminine hygiene products

Storage Temperature: Ambient

LLOQ: 2.5 mL

ULOQ: 50 mL

Precision & Accuracy:

  • LLOQ QC: 15.9% CV; 7.3% Bias
  • Low QC: 3.1% CV; -1.6% Bias
  • Mid QC: 11.8% CV; -5.1% Bias
  • High QC: 4.9% CV; -3.3% Bias
  • Above Range QC (2x Dilution): 9.6% CV; -1.9% Bias

Stability:

  • Short-Term (Bench-Top): 33 hours for Extract
  • Long-Term: 56 days on product at RT; 56 days as venous blood at 4C;
    43 days as venous blood at RT

Comments: Method validated for tampons, pads and pantiliners. The method is also validated in the presence of human urine and vaginal secretions

Method Number: V2344B1. Data for Kotex