An easy-to-use lateral-flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. The Urine Control Set is intended for in vitro diagnostic use in quality-control testing with the OSOM Ultra hCG Combo Test when a urine specimen is used. The Serum Control Set is intended for in vitro diagnostic use in quality-control testing with the OSOM Ultra hCG Combo Test when a serum sample is used.