Transforming biliary care with 5th-generation diagnostics by AGD Biomedicals Pvt. Ltd, India
Editors:
- Dr. Praful B. Godkar (Ph.D)
Eminent Author, Medical Biochemist and Scientist, Technical Education consultant. AGD Biomedicals (Pvt) LTD. - Dr. Gauri Kulkarni MD (Pathology)
Vice President, AGD Biomedicals (Pvt) LTD.
For high-risk category individuals, timely screening of biliary diseases using fifth generation advanced diagnostic reagents, techniques and analyzers significantly reduce morbidity and mortality by enabling rapid intervention and personalized management(1-4). Early use of diagnostic tests related to biliary test panel are strongly recommended in the case of symptoms such as severe abdominal pain, mainly in the upper right side, itchy skin (pruritus), dark yellow urine, pale or clay-colored stools and jaundice(2). Clinical laboratory tests provide up to 70% of the information needed for clinical decision-making and offer a non-invasive foundation for the evidence-based medical treatment(2). Advanced IVD reagents, techniques, and analyzers of AGD Biomedicals, PVT, LTD provide the rapid, actionable data needed to manage high-risk biliary patients. A streamlined, high-performance biliary panel speeds diagnosis, reduces mortality, and enables personalized treatment(7).
NOTE(6)
Gallbladder and biliary tract diseases pose a significant global health burden, yet comprehensive analysis of their long-term epidemiological trends and future projections remain limited.
Q1. Who are high-risk category individuals that require timely screening of biliary diseases?
ANS(1-3):
(A) High-risk age groups: Adults over 40-50 years and seniors over 60 -65 years.
(B) High-risk categories: Individuals with obesity (BMI >30), high serum cholesterol and diabetes mellitus.
(C) Chronic heavy drinkers
(D) Individuals with one or many underlying clinical conditions such as carriers of hepatitis B, hepatitis C, cirrhosis of liver, sickle cell disease, etc.
(E) Patients who recently suffered from rapid weight loss.
(F) Persons with individual or family history of cholestasis.
(G) Patients on long-term hepatotoxic medication such as statins, anti-seizure drugs, drugs related to hormone replacement, drugs on tuberculosis treatment, etc.
NOTE
Women are likely to develop gallbladder disease, mainly those who are pregnant, due to higher estrogen levels, which increase cholesterol in bile.
Q2. Why are high-risk individuals more likely to develop biliary diseases?
ANS(1-3):
(A) People with obesity (BMI over 30), diabetes, and high blood cholesterol frequently develop non-alcoholic fatty liver disease (NAFLD) and bile sludge (thick viscous mixture of bile, calcium salts and cholesterol crystal).
(B) Regular heavy drinking and use of liver-toxic drugs can disrupt cholesterol, bile salts, and phospholipids in the liver, causing biliary dysfunction and bile crystallization.
(C) Rapid Weight Loss increases bile sludge and gallstone formation.
(D) Adults Over 40-50: The risk of gallstones and biliary disease increases significantly after age 40 due to a decline in bile acid synthesis and increased biliary cholesterol. Seniors (Over 60-65): Older individuals have a higher prevalence of asymptomatic gallstones and decreased gallbladder mobility.
NOTE
For newborns, routine examination of biliary system is essential to detect jaundice and prevent kernicterus (damage of brain by high serum bilirubin).
Q3. Which in vitro diagnostic (IVD) test panels are utilized for the screening of biliary diseases?
ANS: Refer Table 1.
Table 1: Biliary Disease Panel Tests And Advantages
| TEST TYPE | TESTS | ADVANTAGES |
| Liver Function Panel | ALT, AST, ALP, GGT, Bilirubin | Early detection of biliary obstruction or hepatopathy. |
| Inflammatory Markers | CRP, Procalcitonin, WBC | Determination and monitoring severity of infection in cholangitis. |
| Biliary Atresia Screen | Conjugated/Direct Bilirubin | Early detection in neonates with cholestasis. |
Q4(7). What are the advantages of timely IVD laboratory screening tests of biliary disease?
ANS: The following are advantages of timely IVD clinical laboratory screening of biliary diseases:
(A) In life-threatening presentations like acute cholangitis or biliary sepsis, where immediate diagnosis can prevent severe complications and death.
(B) In clinical conditions such as biliary atresia (BA), early screening using serum total, direct and indirect bilirubin, can reduce the mean period of diagnosis from 9 weeks to about 6 weeks.
(C) Early diagnosis is associated with prevention of liver damage.
(D) Earlier identification of biliary tract cancers is possible.
NOTE
Advanced IVD biliary laboratory panel tests help distinguish between benign and malignant biliary strictures, reducing the need for repeated or unnecessary invasive procedures.
CASE STUDY
A 53-year-old man with type 2 diabetes and chronic alcoholism arrived at the emergency department (ED) with worsening epigastric pain and high fever. His clinical picture was marked by rigors, persistent nausea, and notable scleral icterus. Due to hemodynamic instability and signs of early sepsis, he was stabilized and transferred to the ICU. His biliary panel laboratory test reports were as follows:
| PARAMETER | RESULT | REFERENCE RANGE |
| Serum total bilirubin | 10.8 mg/dl | Up to 1.0 mg/dl |
| Serum direct bilirubin | 5.9 mg/dl | Up to 0.5 mg/dl |
| Serum indirect bilirubin | 4.9 mg/dl | Up to 0.5 mg/dl |
| SGPT | 970 IU | 5–35 IU |
| SGOT | 1150 IU | 8–40 IU |
| Alkaline phosphatase | 495 IU | 20–80 IU |
| Urine bile pigments | Present, +++ | Absent |
| Urine bile salts | Present | Absent |
| Urine urobilinogen | Present, Increased | Normal |
| Serum amylase | 585 IU | 30–110 IU |
| Serum lipase | 630 IU | > 200 IU |
| Serum GGT | 154 IU | 4-23 IU |
INTERPRETATION(7)
(A) Very high values of serum total bilirubin, direct bilirubin, indirect bilirubin, and the presence of bile salts, bile pigments in urine, elevated levels of SGPT, SGOT, and significantly increased serum alkaline phosphatase are indicative of a post-hepatic condition associated with obstructive jaundice.
(B) Extremely elevated serum gamma-glutamyl transferase (GGT), typically over ten times the normal limit, is usually linked to cholestasis, chronic liver disease, or liver and pancreas tumors.
(C) High values of serum amylase and lipase indicate pancreatic inflammation.
ADDITIONAL TESTS
With reference to symptoms (with high fever), suspected bacterial infection and biliary panel test reports, following addition tests were advised:
(A) Blood culture (to identify bacterial infection): Blood culture revealed methicillin-resistant Staphylococcus aureus (MRSA) infection.
(B) Ultrasound examination report: An ultrasound of the right upper quadrant of the abdomen showed evidence of cholecystitis and biliary dilation.
FINAL DIAGNOSIS
(A) The patient belonged to high-risk category for biliary diseases (refer answer to Q2). Moreover, he was suffering from methicillin-resistant Staphylococcus aureus (MRSA) infection (Iatrogenic infection: Probably acquired from recent hospital procedures).
NOTE
Following rapid IVD laboratory testing, early cholecystectomy, and effective vancomycin treatment, the patient made an excellent recovery.
References
(1) Chapman, R.; Fevery, J.; Kalloo, A.; Nagorney, D.M.; Boberg, K.M.; Shneider, B.; Gores, G.J. Diagnosis and management of primary sclerosing cholangitis. Hepatology 2010, 51, 660–678.
(2) Kiriyama, S.; Kozaka, K.; Takada, T.; Strasberg, S.M.; Pitt, H.A.; Gabata, T.; Hata, J.; Liau, K.H.; Miura, F.; Horiguchi, A.; et al. Tokyo Guidelines 2018: Diagnostic criteria and severity grading of acute cholangitis (with videos). J. Hepatobiliary Pancreat. Sci. 2018, 25, 17–30.
(3) You, H.; Ma, X.; Efe, C.; Wang, G.; Jeong, S.H.; Abe, K.; Duan, W.; Chen, S.; Kong, Y.; Zhang, D.; et al. APASL clinical practice guidance: The diagnosis and management of patients with primary biliary cholangitis. Hepatol. Int. 2022, 16, 1–23.
(4) Nve, E.; Badia, J.M.; Amillo-Zaragueta, M.; Juvany, M.; Mourelo-Farina, M.; Jorba, R. Early Management of Severe Biliary Infection in the Era of the Tokyo Guidelines.
(5) Fanna M, Masson G, Capito C, et al. Management of biliary atresia in France 1986 to 2015: long-term results. J Pediatr Gastroenterol
Nutr 2019;69:416-424.
(6) Dai, F.; Cai, Y.; Yang, S.; Zhang, J.; Dai, Y. Global burden of gallbladder and biliary diseases (1990–2021) with healthcare workforce analysis and projections to 2035. BMC Gastroenterol. 2025, 25, 249.
(7) Godkar PB, Godkar DP. Textbook of Medical laboratory technology (4th edition, 2024), Bhalani Publishers, Mumbai. India.
