Evaluation of the CLINITEST® Human Chorionic Gonadotropin (hCG) Pregnancy Test for Susceptibility to the Hook Effect by the hCG β Core Fragment

[摘要] To the Editor:In a recent report in Clinical Chemistry , Nerenz et al. described a screening method to evaluate point-of-care human chorionic gonadotropin (hCG)1 devices for susceptibility to the hook effect by the hCG β core fragment (hCGβcf) (1). Among the 11 devices they evaluated was the CLINITEST® hCG pregnancy test. Nerenz et al. did not perform the testing for the CLINITEST hCG product themselves but opted to send screening samples to a colleague to perform the test on the CLINITEK® Status+ analyzer according to the manufacturer's instructions. The protocol required that the 3 screening samples be run in duplicate on a single instrument with 1 reagent lot. The results of this testing are shown in Table 1.View this table:Table 1. CLINITEST hCG performance screening method samples.The interpretation of these results by Nerenz et al. was that the test detected intact hCG at 5 × 102 pmol/L, detected hCGβcf at 5 × 105 pmol/L, and gave a false-negative and a borderline result for the sample containing 5 × 102 pmol/L intact hCG + 5 × 105 pmol/L hCGβcf, indicating that this sample is at or near the threshold of a combined hCG and hCGβcf high-dose hook …

[学科分类] 过敏症与临床免疫学