Abstract
<p><strong>Background and Objective</strong>:</p>
 <p>PIVKA-II (Protein induced by vitamin K absence II) is an upcoming and promising new biological marker cited as having a definitive role in the early detection and diagnosis of hepatocellular carcinoma (HCC). Preliminary research shows PIVKA-II reference intervals (RIs) in serum to have substantial racial disparities globally. &nbsp;Hence, this study aimed to determine the RIs and cut-off value of the serum PIVKA-II for the first time in healthy and patients with hepatocellular carcinoma in Pakistan.</p>
 <p>&nbsp;</p>
 <p><strong>Methods:</strong> This cross-sectional study comprised of 240 participants (120 diagnosed cases of HCC and 120 healthy individuals) registered at the Department of Chemical Pathology and Immunology, Chughtai Institute of Pathology, Lahore, Pakistan. The PIVKA-II serum level was analyzed using the Chemistry Analyzer through chemiluminescent micro-particle immunoassay (CMIA). The reference interval was subsequently established using the percentile method.</p>
 <p>&nbsp;</p>
 <p><strong>Results:</strong> In healthy Pakistani adults, the 95 percent reference interval for PIVKA-II was 15.55-43.03mAU/ml, and the cut-off was 148.81mAU/ml in HCC (hepatocellular carcinoma) cases. The male participants, exhibited higher PIVKA-II levels than the females (P &lt; 0.002). There were no significant differences in the serum levels of &nbsp;PIVKA-II with respect to age however variations were observed with respect to gender.</p>
 <p><strong>Conclusions:</strong></p>
 <p>Determination of the reference interval for serum PIVKA-II in healthy adult Pakistani individuals and a cut-off for HCC diagnosis emphasizes the growing need to establish and verify reference intervals of analytes at a larger scale in our population. Ideally all clinical laboratories should establish their own reference intervals.</p>
Highlights
Reference intervals (RIs) allow physicians to make prompt and accurate diagnosis and interpret laboratory findings during the course of disease with a certain level of confidence.1These are crucial for patients’ physiological evaluation, for making a diagnosis or therapeutic management decisions and for monitoring their prognosis. 1-3There is a growing need to establish and verify reference intervals (RIs) of analytes in different populations, owing to different racial and ethnic groups and diverse analytical methodologies used in different laboratories for a single biomarker
9 In Pakistan, cirrhosis is the leading cause of hepatocellular carcinoma (HCC); the etiology of the majority (87%) of cases of hepatic cirrhosis Husnain et al Biomedica. 2021;37(4):259-264 can be attributed to viral hepatitis; out of which Hepatitis C contributes 68% and Hepatitis B contributes 22% of cases
11 Screening for HCC usually comprises of two modalities; radiological examination, and biochemical markers such as alpha-fetoprotein (AFP), both of which are recommended at 6-month intervals in patients with cirrhosis
Summary
Reference intervals (RIs) allow physicians to make prompt and accurate diagnosis and interpret laboratory findings during the course of disease with a certain level of confidence.1These are crucial for patients’ physiological evaluation, for making a diagnosis or therapeutic management decisions and for monitoring their prognosis. 1-3There is a growing need to establish and verify RIs of analytes in different populations, owing to different racial and ethnic groups and diverse analytical methodologies used in different laboratories for a single biomarker. Reference intervals (RIs) allow physicians to make prompt and accurate diagnosis and interpret laboratory findings during the course of disease with a certain level of confidence.. Reference intervals (RIs) allow physicians to make prompt and accurate diagnosis and interpret laboratory findings during the course of disease with a certain level of confidence.1 These are crucial for patients’ physiological evaluation, for making a diagnosis or therapeutic management decisions and for monitoring their prognosis. Protein induced by vitamin K absence-II (PIVKA II) is a promising new biomarker for early detection of HCC and could have a greater role in screening for HCC especially in Pakistan. Protein induced by vitamin K absence II (PIVKA-II) is an upcoming and promising new biological marker cited as having a definitive role in the early detection and diagnosis of hepatocellular carcinoma (HCC).
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