Alpha-fetoprotein Research Articles

Alpha-fetoprotein (AFP), a fetal plasma protein, serves as a diagnostic marker for hepatocellular carcinoma (HCC) and germ cell tumors, with prior genome-wide association studies (GWAS) identifying AFP and PPIP5K1 as associated with its levels. The aim of this study was to identify novel genetic loci associated with serum AFP levels in the Taiwanese population and to elucidate their potential regulatory mechanisms, particularly in liver tissue, by integrating GWAS with expression quantitative trait loci (eQTL) analyses. We conducted a two-stage GWAS of serum AFP levels using participants from the Taiwan Biobank. The discovery cohort included 18 267 individuals, and findings were replicated in an independent sample of 21 994 individuals. Linear mixed models were used to assess genome-wide associations, adjusting for age, sex, and population structure via principal components. Quality control measures were applied to both genotyped and imputed SNPs. To explore functional implications, eQTL analyses were performed using publicly available liver tissue data, focusing on liver-specific regulatory effects. We identified 57 candidate genes across 10 genomic regions on chromosomes 2, 3, 4, 15, 17, and 22. For instance, SNPs in genes like SMC6, SENP7, and TP53BP1 demonstrated significant associations with AFP levels, contributing previously unreported genetic variations. eQTL analysis linked 55 of these genes in regulatory functions, especially within liver tissues, supporting their involvement in AFP expression. Our findings, integrating GWAS and eQTL approaches, enhance understanding of AFP heritability and suggest diagnostic and therapeutic potential for HCC, pending further validation in personalized medicine contexts.

This study investigates the sonographic features, treatment, and prognosis of fetal congenital hepatic hemangioma (CHH), aiming to enhance prenatal diagnostic accuracy and provide insights for standardized management during both the prenatal and postnatal periods. A retrospective analysis was conducted on fetuses diagnosed with CHH by prenatal ultrasound and further confirmed by MRI (magnetic resonance imaging) or CT (computed tomography) between April 2019 and April 2025 at our institution. We analyzed and summarized prenatal and postnatal diagnostic findings, clinical manifestations, management strategies, and clinical outcomes in these patients. A total of 14 patients were included, with a median follow-up of 54 months. The gestational age at diagnosis was 32 ± 6 weeks, and chromosomal analysis revealed normal. Fetal CHH are predominantly solitary lesions (92.9%, 13/14), most commonly located in the right hepatic lobe (64.3%, 9/14). Sonographically, they typically present as well-defined, hypervascular mixed-echogenicity masses. In our cohort, commonly observed features included sieve-like or honeycomb anechoic areas within the lesion. Pulsed Doppler imaging frequently reveals low-to-moderate resistance flow spectra. Two fetuses presented with an enlarged cardiothoracic ratio, one with a giant hepatic hemangioma and one with a non-giant lesion. Additionally, one case of right heart enlargement was observed in a fetus with a giant hepatic hemangioma. One pregnancy was terminated due to poor prognosis secondary to rapid tumor progression in the third trimester; another termination occurred for non-medical reasons during late gestation, and the remaining 12 pregnancies progressed to live births. Among live-born infants, 10 underwent active surveillance postnatally, while 2 required interventional therapy due to oral propranolol failure or persistent tumor growth. Ultimately, complete tumor regression occurred in 8 cases (66.7%, 8/12), with a median follow-up of 24 months. Partial regression in 3 (25.0%, 3/12) and stable disease in 1 (8.3%, 1/12). Additionally, the incidence of postnatal laboratory abnormalities, including hepatic dysfunction, coagulopathy, thyroid disorders, or elevated alpha-fetoprotein (AFP), was 16.7% (2/12) in live-born infants. While prenatal ultrasound manifestations of fetal CHH demonstrate considerable heterogeneity, features are commonly observed in our cohort. Definitive diagnosis can be achieved in most cases through multimodal imaging combining ultrasound with MRI or CT. While most fetuses with CHH have a favorable prognosis, large tumors may cause severe complications and adverse pregnancy outcomes, warranting regular surveillance. For neonates with small tumors or asymptomatic lesions, active observation is the primary management strategy; pharmacotherapy is indicated for rapidly enlarging or large tumors, with interventional or surgical interventions reserved for pharmacologically refractory cases.

A highly sensitive and selective electrochemical immunosensor was developed for the detection of the cancer biomarker alpha-fetoprotein (AFP), a key indicator of cancer. This sensor utilizes the enhanced electrochemical current response generated by a composite material consisting of gold nanoparticles (Au NPs) decorated on a metal-organic framework (MOF) containing iron and cobalt (FeCo). The Au NP-decorated FeCo-based MOF labeled with primary antibodies (Ab1) significantly enhances the electrochemical response, enabling accurate detection of AFP. Similarly, HRP-Au nanoprism (Au NPR) nanocomposites were prepared via a one-pot assembly, where horseradish peroxidase (HRP) and the secondary antibody (Ab2) were coimmobilized on Au NPRs to form a stable nanocomposite. The immunosensor was fabricated by assembling Au NPs@ FeCo-MOF and capture antibodies (Ab1) onto a glassy carbon electrode. The MOF served as a conductive matrix, AuNPs enhanced electron transfer, and Ab1 ensured specific antigen recognition. When the AFP antigen is present, labeled Ab2 binds to the Au NP-decorated FeCo-MOF via specific antigen-antibody interactions, leading to enhanced electrochemical signals for sensitive detection. The immunosensor response was measured by differential pulse voltammetry (DPV) in phosphate-buffered solution (PBS) containing hydrogen peroxide (H2O2) and 3,3',5,5'-tetramethylbenzidine (TMB). Under controlled conditions, the immunosensor exhibited a linear response to AFP over the range of 0.0001 to 100 ng mL-1, with a detection limit of 1.2 pg mL-1 (S/N = 3), indicating high sensitivity. The immunosensor's performance was validated by detecting AFP in human serum samples, demonstrating its potential for ultrasensitive detection of AFP and other biomarkers.

Background: Alpha-feto-protein producing gastric adenocarcinoma is a rare and aggressive subtype of gastric cancer, associated with poor prognosis. Case Presentation: We report the case of a 66-year-old female with a history of hypertension and hypothyroidism who presented with severe anemia and abdominal pain. Initial imaging revealed a gastric lesion. Serum Alfa-Fetoprotein (AFP) was requested due to a suspicious lesion seen on initial liver imaging, and it was markedly elevated (>9000 ng/mL), raising suspicion for AFP-producing gastric cancer versus liver infarction due to venous thrombosis. Endoscopic biopsy of the gastric lesion confirmed Enteroblastic gastric adenocarcinoma. Subsequent MRI abdomen demonstrated hypermetabolic activity in the gastric lesion and in the abdominal lymph nodes without distant metastasis. Given her frailty and reluctance to undergo intravenous chemotherapy, she was offered oral chemotherapy (Capecitabine). Conclusion: Here, we present a case of AFP- producing gastric adenocarcinoma, a rare tumor that has not previously been reported from the Middle Eastern region, to the best of our current knowledge.

Fetal surgery (FS) for spina bifida (SB) repair improves infant outcomes; however, spontaneous preterm birth (sPTB) is common. We aimed to evaluate maternal and fetal immune responses following FS for SB repair. Pregnant participants undergoing fetoscopic SB repair at 24-26weeks of gestational age (GA) were prospectively recruited and compared to GA matched low-risk controls. Blood samples were collected at baseline, 2-week post-surgery (POD14), and delivery. Cytokine analysis, flow cytometry, and T cell receptor (TCR) sequencing were performed. sPTB occurred in 5/6 of the FS group (0/6 of controls). Maternal blood in the FS group demonstrated increased alpha-fetoprotein (AFP) and anti-inflammatory IL-1RA at baseline and POD14, increased pro-inflammatory IL-8 only post-operatively, and elevated growth factors throughout. T cell phenotypes following FS revealed reduced TH17 frequency but increased activation receptors on cytotoxic T cells. At delivery, the FS cohort had reduced Th2 and Th17 helper T cells and CD4+ memory T cells, but CD8 T cells still showed increased activation. No TCR expansion was detected post-surgery, suggesting antigen-independent activation. Cord blood in FS repaired neonates had increased AFP, IL-8, IL-1RA. Systemic immune changes following FS, particularly T cell maturation and activation, were observed. Further characterization of these mechanisms may help predict and prevent surgery-induced PTB, improving outcomes.

Introduction Alpha-fetoprotein (AFP) is a universally recognized tumor marker in hepatocellular carcinoma (HCC). Its utility in assessing the response to immune checkpoint inhibitors (ICIs) remains controversial. This study aims to investigate the predictive value of AFP in ICIs-treated HCC patients. Method A systematic search strategy was deployed across the PubMed, Embase, Cochrane Library and Web of Science databases. Hazard ratios (HR) or odds ratios (OR) and the corresponding 95% confidence intervals (CIs) were used to assess the pooled risk. Result The study encompassed a total of 131 studies. Overall survival (OS) (HR = 1.60, 95%CI=1.47-1.74), progression-free survival (PFS) (HR = 1.35, 95%CI=1.27-1.42), and disease control rate (DCR) (OR = 0.50, 95%CI=0.29-0.84) were poorer in ICIs-treated patients with high AFP levels than those with low AFP levels. However, AFP levels were not associated with the objective response rate (ORR) (OR = 0.96, 95%CI=0.74-1.24). In addition, patients who achieved an AFP response had favorable OS (HR = 0.41, 95%CI=0.33-0.52), PFS (HR = 0.38, 95%CI=0.30-0.47), ORR (OR = 5.39, 95%CI=3.96-7.32) and DCR (OR = 5.48, 95%CI=3.71-8.11). Subgroup analyses revealed that AFP>400ng/ml and AFP decline greater than 20% were the most used and efficient cut-off values for high AFP level and AFP response, respectively. Conclusion High AFP levels are associated with worse outcomes in ICIs-treated HCC. The assessment of AFP response demonstrated promising predictive value for both prognosis and therapeutic response to ICIs. Accurately defining early AFP response remains an area that requires further investigation. Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/ , identifier CRD-42024606729.

This study presents the development of a highly sensitive and selective electrochemiluminescence (ECL) sandwich-type immunosensor for the detection of alpha-fetoprotein (AFP), a critical biomarker for early-stage liver cancer diagnosis. The sensor platform integrates a Fe-Ni-based metal-organic framework (MOF) with magnetic Fe₃O₄ nanoparticles (Fe-Ni-MOF), functionalized with primary antibodies (Ab1). Carbon quantum dots (CQDs) were conjugated with secondary antibodies (Ab2) to serve as ECL luminophores. The immunosensor demonstrated a wide linear detection range for AFP from 0.001 to 1000 ng/mL, with a low detection limit of 0.0084 ng/mL. Structural, morphological, thermal, and optical characterizations confirmed the successful synthesis and functionalization of the composite materials. Moreover, the fabricated sensor exhibited excellent reproducibility, specificity, and stability, indicating its potential as a practical tool for early cancer diagnostics in complex biological samples.

Abstract Extragonadal germ cell tumors (EGGCTs) are rare malignancies that arise outside the gonads and occur infrequently in the gastrointestinal tract. Their presentation often mimics that of other abdominal neoplasms, posing diagnostic challenges. Histopathological and immunohistochemical confirmation, along with tumor marker evaluation, is essential for diagnosis. Early diagnosis and platinum-based chemotherapy can significantly improve patient outcomes. A 25-year-old male presented with abdominal pain, a palpable mass in the umbilical region, and subacute intestinal obstruction. Imaging revealed a heterogeneously enhancing lesion in the mesentery and a subcapsular lesion in the left kidney. Emergency debulking surgery was then performed. Histopathology and immunohistochemistry confirmed an EGGCT favoring a yolk sac tumor. Serum marker levels were elevated with AFP (alpha-fetoprotein) of 854 IU/mL, 23 mIU/mL of β-human chorionic gonadotrophin (β-hCG); 277 U/L of LDH. Ultrasonography of the testes revealed microcalcifications in the left testis, without overt malignancy. The patient was diagnosed with a Stage IIIC extragonadal non-seminomatous germ cell tumor. He was started on an EP regimen owing to poor pulmonary function, followed by BEP, and was scheduled for a high inguinal orchidectomy. This case highlights the importance of including EGGCTs in the differential diagnosis of abdominal masses in young males. A multidisciplinary approach with timely histological and oncological assessments is vital. Early intervention with platinum-based chemotherapy offers a favorable prognosis, even in advanced stages. Given the rarity of this presentation, further studies are needed to refine diagnostic and therapeutic strategies.

Accurate and early detection of alpha-fetoprotein (AFP) in human serum is essential for the diagnosis and monitoring of hepatocellular carcinoma and related diseases. In this study, we present a highly sensitive and reproducible quartz crystal microbalance (QCM) immunosensor for the quantitative detection of AFP. The detection strategy is based on a sandwich-type immunoassay coupled with a signal amplification method utilizing photocatalytic silver deposition on tungsten(IV) oxide (WO3) nanoparticles. Since QCM detects resonance frequency shifts induced by mass changes on the sensor surface, the silver-enhanced growth of WO3 nanoparticles enables significant signal amplification, allowing for precise mass-based quantification. Without amplification, the limit of detection (LOD) for AFP using the QCM immunosensor was 286 pg/mL, which was significantly improved to 43.7 pg/mL with photocatalytic silver staining. This approach markedly improves both sensitivity and reproducibility of the assay, offering a robust and efficient platform for clinical biomarker detection and early cancer diagnostics.

This study aimed to develop and validate a prognostic model for hepatocellular carcinoma (HCC) patients undergoing liver resection, using the functional liver imaging score (FLIS) derived from hepatobiliary-specific contrast-enhanced magnetic resonance imaging (MRI). A total of 694 pathologically confirmed HCC patients who underwent hepatobiliary-specific MRI with either gadoxetic acid or gadobenate dimeglumine and subsequent liver resection were included. FLIS was calculated by assigning 0-2 points to three hepatobiliary-phase MRI features: hepatic enhancement, biliary excretion, and portal vein signal intensity. Multivariable Cox regression identified AFP level, tumor size, and extent of resection as independent predictors of overall survival (OS). FLIS ≤ 2, alpha-fetoprotein (AFP) > 400ng/mL, tumor size > 5cm, and major resection were identified as independent predictors of worse OS. A predictive model combining these factors demonstrated excellent prognostic performance, with Harrell's concordance indices of 0.91 in the training cohort and 0.96 internal validation cohort, and 0.94 in external validation cohort. The FLIS-based model significantly outperformed FLIS alone and conventional clinical models (p < 0.05). Kaplan-Meier survival analysis showed that low-risk patients had significantly better OS and recurrence-free survival (RFS) compared to high-risk patients across all cohorts (p < 0.05). FLIS is a simple, non-invasive imaging biomarker for evaluating liver function and predicting outcomes in HCC patients. When integrated with key clinical variables, the FLIS-based model demonstrates excellent discrimination and calibration for OS and RFS, providing accurate postoperative prognostic stratification and showing great potential for guiding surveillance and improving long-term survival outcomes in future clinical applications.

Rapid and portable detection of hepatocellular carcinoma marker alpha-fetoprotein using a droplet evaporation-based biosensor.

DNA triangular prism nanostructure and CRISPR/Cas12a empowered electrochemical biosensor for dual detection of alpha-fetoprotein and microRNA 122.

Comparison of the GALAD, GAAP, and ASAP Scores for Hepatocellular Carcinoma Detection in Patients With Chronic Liver Diseases.

Hepatoid Adenocarcinoma of the Lung (HAL) is a rare type of Non-Small Cell Lung Cancer (NSCLC), histologically similar to Hepatocellular Carcinoma (HCC). Hepatoid adenocarcinoma presenting as soft-tissue swelling is extremely rare. Less than 40 well-documented cases in the literature have been added to date. Diagnostic work-up included clinical history, Alpha-Fetoprotein (AFP) serum marker level, imaging, histological uniqueness, immunohistochemical expression, and molecular testing. Hepatoid adenocarcinoma of the lung has high malignancy and poor prognosis and needs a better treatment plan. Hence, we report a case of a 73-year-old male presenting with a history of swelling on the right arm for three months. On Magnetic Resonance Imaging (MRI), the soft-tissue swelling radiological features were suggestive of sarcoma. An excisional biopsy was done. Histomorphological and immunohistochemical expression revealing features of metastatic deposits from hepatoid adenocarcinoma of the lung. Patient expired during follow-up. Hepatoid adenocarcinoma of the lung is a special type of NSCLC. The surgical treatment of HAL in the limited stage can achieve long-term survival, but most of them are in the advanced stage when they are found, and the prognosis is poor, which requires multidisciplinary comprehensive treatment.

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and one of the leading causes of cancer-related deaths worldwide. Early diagnosis of HCC, as well as the identification of biomarkers that can help determine the effectiveness of applied treatments, is extremely important. In the present study, the effects of Theranekron (TCAE, Tarantula cubensis alcoholic extract) and Sorafenib (S) on plasma and liver tissue levels of alpha-fetoprotein (AFP), heat shock protein 90 alpha (HSP90α), and indoleamine 2,3-dioxygenase 1 (IDO1) were investigated in Wistar-Albino rats with experimentally induced HCC using diethylnitrosamine (DEN) and n-nitrosomorpholine (nMOR). The study included a total of 58 rats divided into 7 groups: Healthy Group (HG, n = 6), HG + TCAE (HGT, n = 6), HG + Sorafenib (HGS, n = 6), HCC Control (HC, n = 10), HCC + TCAE (HT, n = 10), HCC + Sorafenib (HS, n = 10), and HCC + TCAE + Sorafenib (HTS, n = 10). Plasma and liver AFP, HSP90α, and IDO1 levels were found to be significantly elevated in the HC group compared with the healthy control groups (p < 0.001). Administration of Theranekron and Sorafenib, either alone or in combination, resulted in significant reductions in AFP, HSP90α, and IDO1 levels, particularly in plasma (p < 0.001). Furthermore, histopathological evaluation revealed that Theranekron and Sorafenib treatments exhibited less tumorigenic morphology compared with the HC group. Taken together, these results demonstrate that Theranekron enhances the antitumor efficacy of Sorafenib. Moreover, HSP90α and IDO1 levels appear to provide higher specificity and sensitivity, suggesting their potential as more reliable biomarkers for monitoring tumor prognosis.

BACKGROUNDChronic liver disease (CLD) causes approximately two million deaths each year, and its clinical diagnosis and management remain challenging. Ultrasound is currently the most widely used technique for disease detection.AIMTo propose a practical cut-off value for identifying patients with hepatocellular carcinoma (HCC) among those with compensated advanced CLD or healthy individuals using the GALAD score, an algorithm based on a formula that incorporates gender, age, serum alpha-fetoprotein (AFP), AFP-L3, and des-gamma-carboxy prothrombin values.METHODSThis cross-sectional analysis was conducted using prospectively collected data from five cohorts (n = 1431) comprising healthy individuals, cirrhosis, and HCC patients. These subjects were enrolled from an Italian retrospective cohort, including patients from the IRCCS “Saverio de Bellis”, Department of Gastroenterology, the University of Modena and Reggio Emilia Gastroenterology Department, and the Padua University Hospital and the Department of Gastroenterology, Hepatology, Infectious diseases and Endocrinology, Hannover Medical School.RESULTSUsing healthy subjects as reference, a GALAD score cut-off of -1.67 identified HCC with a sensitivity of 89.77% and specificity of 97.59%. Individuals with GALAD values > -1.67 exhibited a moderate to very high probability (over 90%) of having HCC. When cirrhotic patients were used as the reference category, a cut-off of -0.77 yielded a sensitivity of 78.17% and a specificity of 89.55%.CONCLUSIONWe strongly recommend incorporating this GALAD cut-off into clinical guidelines for the screening of patients with a compensated advanced CLD who are at high risk of developing HCC. Given the rapid global rise in metabolic-associated steatotic liver disease (MASLD)-related CLD, future research should prioritize larger MASLD cohorts to establish the most appropriate GALAD cut-off for diagnostic use, compared to healthy controls and to patients with other forms of CLD.

Background:Alpha-fetoprotein (AFP) and protein induced by vitamin K absence or antagonist-II (PIVKA-II) are classical tumor markers in clinical practice. However, the relationship between tumor markers and prognosis in hepatocellular carcinoma (HCC) patients receiving immune checkpoint inhibitor (ICI) therapy remains unclear.Objectives:This study aims to explore the prognostic value of AFP and PIVKA-II in HCC patients treated with ICIs.Design:This study was a single-center, retrospective investigation aimed to assess the prognostic value of AFP and PIVKA-II in HCC patients receiving immune checkpoint inhibitors.Methods:This retrospective study included HCC patients who received ICIs treatment at Wuhan Union Hospital between July 2020 and March 2024. Serum AFP and PIVKA-II levels were collected before treatment. Patients were stratified into two groups based on AFP ⩾ 400 μg/L (yes = 1, no = 0) and PIVKA-II ⩾ 40 mAU/mL (yes = 1, no = 0). A total of 61% (114/186) of patients scored ⩽ 1, while 39% (72/186) scored 2. The objective response rate (ORR) and disease control rate (DCR) were calculated for both groups. Kaplan–Meier survival curves and Cox regression models were used to analyze overall survival (OS) and progression-free survival (PFS). Receiver operating characteristic curves were generated to demonstrate the predictive ability of combined independent prognostic factors for long-term survival.Results:The cohort consisted of 186 patients, divided into the low-risk group (n = 114) and the high-risk group (n = 72). Among all patients, 34.4% (64/186) achieved complete or partial response. Concurrent elevation of AFP and PIVKA-II was inversely associated with ORR (p = 0.012). The high-risk group exhibited significantly shorter OS (adjusted HR: 2.226 (95% CI: 1.410–3.513); p < 0.001) compared to the low-risk group. The integrated model combining AFP, PIVKA-II, and Barcelona Clinic liver cancer stage demonstrated moderate to good predictive capability for long-term risk stratification, with time-dependent area under the curves of 0.78 (9-month), 0.68 (12-month), and 0.63 (15-month).Conclusion:Concurrent elevation of AFP and PIVKA-II is significantly associated with shorter survival outcomes in HCC patients following ICI therapy.

Hepatocellular carcinoma (HCC) is a leading cause of cancer mortality globally, with particularly high burdens among people living with HIV (PLWH) in low-resource settings like Nigeria. Effective early detection remains a major challenge due to limited access to imaging-based surveillance and the low sensitivity of current biomarkers such as alpha-fetoprotein (AFP). We conducted an epigenome-wide association study (EWAS) of circulating cell-free DNA (ccfDNA) methylation in a Nigerian cohort of HIV-positive individuals (n = 245), spanning HCC, cirrhosis (FibroScan ≥12.3 kPa), fibrosis (FibroScan ≥7.6 and <12.3 kPa), and HCC-free without fibrosis (FibroScan <7.6 kPa) groups. Using random forest modeling, we developed and evaluated a ccfDNA methylation classifier (ccfDNAmRF) for HCC risk prediction. We identified 73 CpG sites significantly associated with HCC (false discovery rate <0.01). The ccfDNAmRF model demonstrated strong discriminatory power, achieving 100% sensitivity and 80%-91% specificity for distinguishing HCC from cirrhosis, fibrosis, and HCC-free groups (area under the curve [AUC]: 92%-97%). Combining ccfDNA methylation risk scores with AFP further improved classification accuracy (AUC up to 98.5%). Notably, ccfDNA methylation patterns displayed clear dose-response relationships across the disease spectrum, supporting their utility for early-stage detection and risk stratification. Our findings highlight the promise of ccfDNA methylation biomarkers as a non-invasive, blood-based screening tool for improving early identification of HCC cases among PLWH.

Alpha-fetoprotein (AFP) and its isoform AFP-L3 are well-established serum biomarkers for hepatocellular carcinoma (HCC), a common malignancy and a leading cause of cancer-related mortality worldwide. Current methods for measuring these biomarkers are primarily lectin-based assays including the liquid-phase binding assay (LiBA) and liquid chromatography-tandem mass spectrometry (LC-MS/MS), both of which have limitations in diagnostic sensitivity and clinical utility for samples with low AFP concentrations. We aimed to develop a lectin-independent LC-MS/MS method for quantifying fucosylated AFP proteins (AFP-Fuc%). We conducted analytical validation, including method comparisons, over 2 months. The analytical sensitivity and diagnostic performance of this method were evaluated using 525 human serum samples-235 from HCC patients and 290 from non-HCC individuals-and compared with those of LiBA, which measured AFP-L3 levels. The LC-MS/MS method demonstrated acceptable within-laboratory imprecision (CVs<17.1%) without detectable bias, carryover, or matrix effects. Our method exhibited a broader linear dynamic range (spanning five orders of magnitude) and 10-fold higher analytical sensitivity than LiBA. The diagnostic performance of our method was significantly superior to that of LiBA, particularly in patients with low AFP concentrations (<7 ng/mL, P <0.001), with improved accuracy, sensitivity, and precision at a specificity of 96.2%. The validated LC-MS/MS method demonstrated robust analytical performance and superior diagnostic accuracy over LiBA for HCC diagnosis while avoiding the inherent limitations of lectin-based assays. Our LC-MS/MS assay shows promise for early HCC detection and may contribute to enhanced patient care.

PIVKA-II as a prognostic marker in hepatocellular carcinoma patients with normal serum alpha-fetoprotein levels.