Prospective evaluation of FIBROSpect II for fibrosis detection in hepatitis C and B patients undergoing laparoscopic biopsy

Lennox J Jeffers, Rafael A. Cortes, Pablo A Bejarano, Esther Oh, Arie Regev, Katie M. Smith, Maria De Medina, Margaret Smith-Riggs, Marlene Colon, Keith Hettinger, Sandra Jara, Tulia Patricia Mendez, Eugene R. Schiff

Research output: Contribution to journalArticlepeer-review

6 Scopus citations


Serum markers of liver fibrosis are difficult to validate, due to the sampling error and observer variability associated with percutaneous liver biopsies. Laparoscopic biopsy decreases sampling error and increases the reliability of histopathologic assessment. We prospectively evaluated the FIBROSpectSM II serum marker test for viral liver fibrosis against laparoscopic biopsies by studying 145 patients with chronic hepatitis B or C who underwent laparoscopy in a tertiary care setting. Serum samples obtained at biopsy were tested with FIBROSpect II to assess the degree of fibrosis. Multiple biopsies were obtained from each patient and scored blindly using the Batts-Ludwig system. An average biopsy stage was calculated and the performance of the test panel assessed. FIBROSpect II was able to rule in significant fibrosis (stages 2-4), with a likelihood ratio of 2.6. It correctly indicated absence of disease in 74% of stages 0-1 patients and correctly predicted significant disease in 67% of stages 2-4 patients. Test correlation was highest with Batts-Ludwig stages 3 (77%) and 4 (96%) and lowest with stage 2 (43%). Multiple biopsies from 52% of patients differed by at least 1 stage. In 13 patients (9%), cirrhosis was detected by laparoscopy but not histologically; in 4 (3%), a stage of 4 was obtained, but cirrhosis was not evident by laparoscopy. FIBROSpect II provided valuable additional information for assessing fibrosis. The discordance in fibrosis stage seen in multiple biopsies from the same patient underscores the need to consider all available information when assessing fibrosis. This study confirms and extends results of previous studies evaluating FIBROSpect II using percutaneous liver biopsy.

Original languageEnglish (US)
Pages (from-to)367-376
Number of pages10
JournalGastroenterology and Hepatology
Issue number5
StatePublished - May 2007


  • Biopsy
  • Fibrosis
  • FIBROSpect II
  • Hepatitis B
  • Hepatitis C
  • Laparoscopy
  • Noninvasive
  • Serum markers

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology


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