A blind study of the polymerase chain reaction for the detection of Mycobacterium tuberculosis DNA. Azay Mycobacteria Study Group.
METHODS
Nine French laboratories routinely involved in mycobacterial work.


OBJECTIVE
To assess the detection of Mycobacterium tuberculosis in experimental samples by polymerase chain reaction (PCR) using the insertion sequence IS6110 as a target for deoxyribonucleic acid (DNA) amplification.


METHODS
Nine laboratories participated in a blind study of the detection of M. tuberculosis by PCR in 20 coded samples containing either a definite number of M. tuberculosis complex (positive samples) or environmental mycobacteria (four samples) or no mycobacteria (five samples).


RESULTS
Five laboratories reported false-positive PCR results, with an average rate of 7%. All laboratories except one reported positive PCR results for samples containing 10(5) cfu/ml or more. M. tuberculosis DNA was detected in two thirds of samples containing 10(4) and 10(3) cfu/ml, and in one third of the samples containing 10(2) cfu/ml.


CONCLUSIONS
The results of the study suggest that PCR using IS6110 as a target for DNA amplication is neither very sensitive nor really specific for the detection of M. tuberculosis.
Doucet-Populaire
F
F
Hôpital Pitié-Salpétrière, Paris, France.
Lalande
V
V
Carpentier
E
E
Bourgoin
A
A
Dailloux
M
M
Bollet
C
C
Vachée
A
A
Moinard
D
D
Texier-Maugein
J
J
Carbonnelle
B
B
Grosset
J
J
D004269:DNA, Bacterial / Q000032:analysis*; D005189:False Positive Reactions; D006801:Humans; D009161:Mycobacterium / Q000737:chemistry; D009169:Mycobacterium tuberculosis / Q000737:chemistry*; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D016037:Single-Blind Method; D013183:Sputum / Q000382:microbiology
D004269:DNA, Bacterial