Abstract:Objective Establishing a simple and rapid loop-mediated isothermal amplification (LAMP) to detect Candida albicans (CA), and exploring its clinical value in the diagnosis of vulvovaginal candidiasis (VVC). Methods Primer Explorer V5 software was used to design CA LAMP primers ; First, optimizing LAMP test, and then evaluating the detection specificity and the minimum detection limit; Vaginal swabs were collected from 123 VVC patients and 42 healthy patients. Fungal culture, LAMP test, PCR test, and 10% KOH microscopy were conducted in parallel. Fungal culture was used as the reference method for VVC diagnosis; The detection positive rate among two groups was compared by Pearson 2 test. The consistency among LAMP, PCR, microscopy and culture was performed by Kappa test, P<0.05 was considered statistically significant; ROC curve analysis was used to evaluate LAMP test, PCR test. Results LAMP optimum reaction temperature is 61°C; The specificity was high, and there was no cross reaction with other strains; The detection limit was 103 copies/ul. LAMP, PCR and 10%KOH among the VVC group and the healthy group were statistically significant (LAMP,2=68.576;PCR,2=64.918;microscopy,2=50.076,P<0.01); LAMP detection and PCR have good consistency (κ=0.744,κ=0.720), microscopy examination have poor consistency (κ=0.533); The area under the curve of LAMP and PCR microscopy was 0.873 and 0.888, respectively. No difference in efficacy between LAMP and PCR(Z = 0.849, P = 0.3956), but the LAMP lowest detection is shorter than 1h. LAMP has a diagnostic sensitivity of 87.62%, specificity of 88.33%, positive predictive value of 92.93% and negative predictive value of 80.30%. Conclusion A rapid, reliable, sensitive and specific LAMP technique for detecting Candida albicans was established. The turnround time is greatly shortened, and the comprehensive screening performance is superior to the laboratory routine method. LAMP can be used for the supplementary diagnosis and therapeutic effect monitoring in Candida albicans infection.