Development and clinical trial of fluorescence PCR diagnostic kit to detect Mycobacterium tuberculosis.
OBJECTIVE
To develop a new diagnostic kit for Mycobacterium tuberculosis (TB) detection on the basis of fluorescence PCR (F-PCR) and conduct clinical trial of this kit for assessing its performance in comparison with other diagnostic methods.


METHODS
We collected 546 clinical sputum samples from patients with phthisis and normal subjects to examine TB by way of F-PCR in parallel with examination with modified R.culture, auramine smear with fluorescence staining and LCx DNA diagnostic kit from Abbott for comparison.


RESULTS
A clinical diagnostic kit for TB detection was developed with F-PCR, and clinical trial showed that its positivity rate was 49.1%, sensitivity 89.2%, specificity 98.8% and efficiency 93.6%.


CONCLUSIONS
F-PCR is obviously superior to culture method and smear method and comparable with LCx in terms of sensitivity, and can be used to monitor TB DNA in the secretions to facilitate clinical diagnose and therapeutic effects monitoring.
Cheng
Gang
G
Da'an Gene Diagnostic Center, Sun Yet-sen University, Guangzhou 510089, China.
He
Yun-Shao
YS
Zhou
Xin-Yu
XY
Deng
Wen-Guo
WG
Li
Hu
H
D004269:DNA, Bacterial / Q000032:analysis*; D005453:Fluorescence; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods; D011933:Reagent Kits, Diagnostic; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology
D004269:DNA, Bacterial; D011933:Reagent Kits, Diagnostic