Methodology

Immunochromatographic

General Information:

Qualitative test—for use on specimens from females only. Specimens from males will not be analyzed. For males, see LAB143 Chorionic Gonadotropin (hCG), Quantitative, Serum.

Note: In rare instances of trophoblastic disease, urine hCG concentrations may be high enough to produce a false-negative value due to a “high-dose hook effect.” Due to observation of such samples it is determined that hCG concentrations >1,000,000 mIUnits/mL will cause false-negative values. If a result is not consistent with clinical impression or other data, the sample should be repeated using a 1:10 dilution which will eliminate the “high-dose hook effect.”

Literature Reference:

Package insert: OSOM Ultra hCG Combo Kit by Sekisui Diagnostic