Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism.
The immune colloidal gold (ICG) method of measuring thyroid-stimulating hormone (TSH) is a rapid and easy-to-perform test, allowing off-site measurements. This study compared the clinical utility of the first ICG-based qualitative and quantitative TSH test methods in China with the third-generation serum TSH assay used worldwide.



Fingertip and venous blood was collected within 30 min from 283 patients initially suspected of hypothyroidism. TSH was measured in fingertip blood using ICG-based qualitative quantitative tests. Serum TSH in venous blood was tested using the third-generation serum TSH assay. Correlations between systems were tested by kappa or Spearman correlation coefficients.



Compared with the third-generation serum TSH assay, the ICG-qualitative TSH test kit had a kappa coefficient of 0.86, a sensitivity of 85.00%, and a specificity of 99.38% in screening for hypothyroidism. The percentages of false negatives and false positives among all subjects were 6.38% and 0.35% respectively; the total consistency rate of the two methods was 93.26%. When compared with the third-generation serum TSH assay, the ICG-quantitative TSH analysis system had a Spearman correlation coefficient of 0.91, a sensitivity of 88.43%, and a specificity of 98.77%. The percentages of false negatives and false positives among all subjects were 4.95% and 0.71%, respectively; the total consistency rate of the two methods was 94.35%.



Both ICG-based assays are easier and faster to perform than the third-generation, laboratory-based serum TSH assay method. The ICG-based methods showed acceptable performance in the simplified screening for hypothyroidism.



ClinicalTrials.gov identifier, NCT01921452.



Merck Serono Co., Ltd.
Department of Nuclear Medicine, Shanghai Jiaotong University, Affiliated Sixth People's Hospital, Shanghai, China.
Tingting
T
Wang
Department of Nuclear Medicine, Shanghai Jiaotong University, Affiliated Sixth People's Hospital, Shanghai, China.
Shiwei
S
Sheng
Department of Medical Affair, Merck Serono Co., Ltd. (an Affiliate of Merck KGaA, Darmstadt, Germany), Beijing, China.
Meifang
M
Ruan
Department of Medical Affair, Merck Serono Co., Ltd. (an Affiliate of Merck KGaA, Darmstadt, Germany), Beijing, China.
Jing
J
Yan
Department of Nuclear Medicine, Shanghai Jiaotong University, Affiliated Sixth People's Hospital, Shanghai, China.
Jianying
J
Gu
Department of Nuclear Medicine, Shanghai Jiaotong University, Affiliated Sixth People's Hospital, Shanghai, China.
Yumin
Y
Jiang
Department of Nuclear Medicine, Shanghai Jiaotong University, Affiliated Sixth People's Hospital, Shanghai, China.
Yunchao
Y
Gao
Department of Nuclear Medicine, Shanghai Jiaotong University, Affiliated Sixth People's Hospital, Shanghai, China. luhankui@sina.com.
Hankui
H
Lu
D000328:Adult; D002681:China; D019411:Clinical Laboratory Techniques / Q000379:methods; D057186:Comparative Effectiveness Research; D005260:Female; D017979:Gold Colloid / Q000494:pharmacology*; D006801:Humans; D007037:Hypothyroidism / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013972:Thyrotropin / Q000032:analysis*
D017979:Gold Colloid; D013972:Thyrotropin
Hypothyroidism; Immune colloidal gold; Thyroid-stimulating hormone; Thyrotropin