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. 2022 Nov 25;22(1):194.
doi: 10.1186/s12894-022-01122-4.

Diagnostic performance of an immunoassay based on urine exfoliated cell enrichment nanotechnology for upper tract urothelial carcinoma: a retrospective, monocentric study

Xin Wang #  1 , Shiwei Zhang #  1 , Lang Wu #  2 , Baofu Feng  1 , Hongwei Shen  1 , Yuanyuan Gu  2 , Qun Zhang  2 , Feng Fang  3 , Rong Yang  4 , Hongqian Guo  5
Affiliations

Diagnostic performance of an immunoassay based on urine exfoliated cell enrichment nanotechnology for upper tract urothelial carcinoma: a retrospective, monocentric study

Xin Wang et al. BMC Urol. .

Abstract

Background: Noninvasively urine-based diagnostic modalities for upper urinary tract urothelial carcinoma (UTUC) were still lacking. We evaluated the diagnostic value of our previously developed urine-based assay (UTC assay) in UTUC.

Methods: We retrospectively analyzed 90 patients with suspected UTUC and 40 donors without UTUC. Voided urine specimens were analyzed by UTC assay and fluorescence in situ hybridization (FISH). The performance of UTC assay and FISH was compared among the 60 histologically proven UTUC patients and the 40 donors with benign disease.

Results: Of the 60 UTUCs, there were 8 low-grade and 52 high-grade cases. Overall sensitivity for UTC assay and FISH were 85% and 73.3%, respectively (P = 0.116). Specificities for UTC assay and FISH were 92.5% and 95%, respectively (P = ns.). By grade, sensitivities of UTC assay and FISH were 87.5% vs. 37.5% for low-grade (P = 0.119), and 84.6% vs. 78.8% for high- grade UTUC (P = 0.446), respectively. By stage, UTC assay showed significantly higher sensitivity than FISH for detecting non-muscle-invasive UTUC, which were 88.5% vs. 61.5%, respectively (P = 0.025).

Conclusion: UTC assay has good performance for the non-invasive diagnosis of UTUC. UTC assay may improve the diagnosis and surveillance of low-grade or superficial UTUC.

Keywords: FISH; Immunocytology; Upper urinary tract; Urine; Urothelial carcinoma.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flow chart. UC = urothelial carcinoma, UTUC = upper urinary tract urothelial carcinoma
Fig. 2
Fig. 2
Schematic diagram of UTC assay detection workflow
Fig. 3
Fig. 3
Example of the positive UTC assay result from a voided urine sample of UTUC. a UC cells (cyan arrows) and WBC (yellow arrow) were detected by immunofluorescence staining of cells captured on NS. Scale bar: 50 μm. b Magnified view of UC cells indicated by cyan arrows in (a), showing CK20+DAPI+CD45−CD11b−. c Magnified view of the WBC cell indicated by yellow arrow in (a), showing CK20−DAPI+CD45+CD11b−.
Fig. 4
Fig. 4
Examples of abnormal FISH images for each probe from voided urine samples of UTUC. a Polyploidy of chromosomes 3 (green) and 7 (cyan). b Aneuploidy of chromosomes 3 (green) and 17 (red). c Polyploidy of chromosomes 3 (green), 7 (cyan) and 17 (red), top left. d Homozygous deletions of P16 (9p21) (0 red), and amplification of chromosomes 3 (green)
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References

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