The Establishment Of Methodology Of Combined Detection Of Serum Sialic Acid And Hydroxyproline And Its Primary Clinical Application

Objective:To combined detect the serum sialic acid (SA) and hydroxyproline (Hyp) concentration(SA&Hyp) and analyze its relationship with clinicopathological characteristic. To compare the clinical value with the traditional common used markers and find the clinical diagnostic significance of combined detection of serum S A and Hyp.Method:1.5ml serum samples were collected from every patient, then centrifuged with 3000 r/min for 5min. The collected serum must be determined immediately, stored at 4℃,-20 ℃ or -80℃ for long-time detection.2. The serum SA&Hyp concentrations were determined by using SA&Hyp Detection Kit (Qingdao Boxin Biotechnology Co.Ltd) with the method of spectrophotometry detected by GF-EⅡ machine. The detect process was in accordance with SA&Hyp detection kit. The values> 95U/ml are considered positive according to the kit.3. CEA, HE4 and CA125 were determined on the Roche Cobas e601 analyzer by using electrochemiluminescence immunoassay method with Elecsys CEA kits, Elecsys HE4 kits (Roche Laboratories) and Elecsys CA125Ⅱkits (Roche), respectively. All the detections were quality controlled.Results:1. The serum SA&Hyp and CEA levels in the patients with CRC [(106.1 ± 10.2)U /mL and (11.9±9.8) ng/mL] were significantly higher than those in the patients with colorectal adenomas or polyps and healthy individuals (P< 0.05). The positive rates of serum SA&Hyp and CEA levels (74.8% and 47.1%) in the patients with CRC were also significantly higher than those in the patients with colorectal adenomas or polyps and healthy individuals (P<0.05).2. The expression level and positive rate of serum SA&Hyp in staging III and IV were much higher than staging Ⅰ and Ⅱrespectively(t=4.876,;χ2=9.418, P<0.05); the patient characteristics such as age, sex and tumor site had no influence on the result of serum SA&Hyp in CRC patients (P>0.05).The serum SA&Hyp level had a significant decline in 7days and 10 days after surgery (P<0.05), while CEA showed no significant change.3. Serum SA&Hyp and CEA level were highly positively related (r=0.534, P<0.05) The receiver operating characteristics curve analysis for differentiating the CRC and colorectal adenomas patients form healthy individuals showed that SA&Hyp showed a greater area under the curve when compared with CEA(Z=3.076, P<0.05), and the sensitivity of combined detection of SA&Hyp and CEA (85.2%)was significantly higher than solo detection (74.8%,47.1%, P<0.05).4. Serum SA&Hyp concentrations were influenced significantly by renal failure and pregnancy but not age and menopausal status. The median concentrations of SA&Hyp, HE4 and CA125 in patients with ovarian cancer were 119.0 U/ml,190.2 pmol/1 and 366.0 pmol/1, which were significantly higher than concentrations in patients with benign gynecologic diseases (P< 0.001). 5. SA&Hyp showed a significantly higher AUC than HE4 and CA125 in the diagnosis of gynecologic malignancies (P< 0.001), while no significance was found when compared with ROMA. Specially, SA&Hyp in 48.3% subjects (29/60) diagnosed as positive before primary surgery showed negative after surgery.Conclusion:1. The serum level of SA&Hypin patients with CRC were highly increased, which can be helpful in screening and dynamic monitoring of CRC.Therefore,it is hoped to be used for auxiliary diagnosis of CRC.2. Renal failure and pregnancy are the main source for increased false positive of SA and Hyp. Compared with HE4 and CA125, SA&Hyp shows a better diagnosis value and can be used in the diagnosis and dynamic monitoring of gynecologic pelvic malignancies, while no statistical significance was found compared with ROMA.