BACKGROUND: Nested nucleic acid amplification tests are often thought too sensitive or prone to generating false positive results for routine use. The current study investigated the specificity and clinical utility of a routine multiplex nested assay for @entity33 . METHODS: Ninety @entity1 , categorised into those clinically diagnosed to (a) have and (b) not have @entity281 , were enrolled. Swabs from oral and ano-genital sites were assayed by the nested assay and culture and the results assessed against clinical evaluation for diagnosing @entity281 ; cell content was also recorded. RESULTS: Twenty-six and 64 @entity1 were thought to (a) have and (b) not have @entity33 . Taking the clinical evaluation as indicating the presence of @entity281 , the nested polymerase chain reaction and culture had respective sensitivities of 19/26 (73%) and 12/26 (46%) (Chi2 p = 0.02). There was no significant difference in specificities between @entity14588 62/64 (97%) and culture 63/64 (98%) (Chi2 p = 1.0). Cell content was important for viral detection by @entity14588 (Chi2 p = 0.07) but not culture. Nesting was found necessary for sensitivity and did not reduce specificity. Assay under-performance appeared related to sub-optimal cell content (20%) but may have reflected clinical over-diagnosis. The results suggest the need for validating specimen cell quality. CONCLUSIONS: This study questions the value of routine laboratory confirmation of @entity33 . The adoption of a more discriminatory usage of laboratory diagnostic facilities for @entity281 , taking account of cell content, and restricting it to those cases where it actually affects @entity1 management, may be warranted.

Clinical utility of a nested nucleic acid amplification format in comparison to viral culture for the diagnosis of XXXX in a genitourinary medicine setting.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity281 :: ('MESH:D007239', 'Disease') :: ['herpetic infections', 'herpetic infection', 'genital herpetic infection'] @entity33 :: ('MESH:D052016', 'Disease') :: ['mucosal herpetic infection', 'mucosal herpetic infections'] @entity14588 :: ('246734', 'Gene') :: ['nPCR']
@entity33 :: (MESH:D052016,Disease) :: ['mucosal herpes simplex infection']
