PMID- 36787561
OWN - NLM
STAT- MEDLINE
DCOM- 20230216
LR  - 20230216
IS  - 1433-6510 (Print)
IS  - 1433-6510 (Linking)
VI  - 69
IP  - 2
DP  - 2023 Feb 1
TI  - Analytical Evaluation and Reference Interval Investigation for Chinese Han 
      Population in Wuhan of CA72-4 Performed on an Architect i2000sr System.
LID - 10.7754/Clin.Lab.2022.220432 [doi]
AB  - BACKGROUND: Carbohydrate antigen 72-4 (CA72-4) is a mucin-like, tumor-associated 
      glycoprotein. Its elevation in serum has been found to be associated with various 
      carcinomas. The purpose of this study was to evaluate the analytical performance 
      of the Architect chemiluminescent immunoassay CA72-4 on the Architect i2000sr 
      platform and to determine the reference interval (RI) of CA72-4 for the Chinese 
      Han population in the city of Wuhan. METHODS: We evaluated the precision, 
      analytical sensitivity, linearity and interference according to the guidelines of 
      the Clinical Laboratory Standardization Institute. Additionally, the Abbott 
      Architect i2000sr CA72-4 assay was compared to the Roche Cobas E602 CA72-4 assay. 
      A total of 448 healthy individuals were selected to determine the RIs of CA72-4. 
      RESULTS: The assay had an imprecision of 1.38% - 2.63% within runs, 1.41% - 2.73% 
      between runs and a total imprecision of 2.54% - 4.10%. The limit of blank, limit 
      of detection and limit of quantitation concentrations were 0.19 U/mL, 0.21 U/mL, 
      and 0.21 U/mL. Linearity was confirmed across the entire measurable range. 
      Additionally, the carryover was less than 0.065%. Interferences with hemoglobin, 
      conjugated bilirubin and lipemia were acceptable with changes of less than 10%. A 
      correlation coefficient of 0.9450 was determined through the method comparison 
      experiment (95% CI 0.9318 - 0.9557). The RI for serum CA72-4 in the Han 
      population was established as an upper limit, 11.13 U/mL (90% CI 9.39 - 12.99) by 
      using the Abbott Architect i2000sr system. CONCLUSIONS: This study establishes a 
      RI for the Chinese Han population in Wuhan using the Abbott Architect i2000sr 
      CA72-4 assay and demonstrates an analytical performance for clinical use.
FAU - Deng, Lingyan
AU  - Deng L
FAU - Li, Huijun
AU  - Li H
FAU - Wang, Xu
AU  - Wang X
FAU - Yin, Tongxin
AU  - Yin T
FAU - Cheng, Liming
AU  - Cheng L
LA  - eng
PT  - Journal Article
PL  - Germany
TA  - Clin Lab
JT  - Clinical laboratory
JID - 9705611
RN  - 0 (CA-72-4 antigen)
RN  - 0 (Antigens, Tumor-Associated, Carbohydrate)
SB  - IM
MH  - Humans
MH  - *Carcinoma/diagnosis
MH  - East Asian People
MH  - Immunoassay/methods
MH  - Immunologic Tests
MH  - *Antigens, Tumor-Associated, Carbohydrate/blood
EDAT- 2023/02/15 06:00
MHDA- 2023/02/17 06:00
CRDT- 2023/02/14 16:46
PHST- 2023/02/14 16:46 [entrez]
PHST- 2023/02/15 06:00 [pubmed]
PHST- 2023/02/17 06:00 [medline]
AID - 10.7754/Clin.Lab.2022.220432 [doi]
PST - ppublish
SO  - Clin Lab. 2023 Feb 1;69(2). doi: 10.7754/Clin.Lab.2022.220432.