A Preliminary Evaluation of the Gonozyme® Test

Burns, Mark W.; Rossi, Pamela H.; Cox, Denise W.; Edwards, Teresa A.; Krámer, M; Kraus, Stephen J.

doi:10.1097/00007435-198311000-00003

Cited by 17 publications

(9 citation statements)

References 9 publications

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“…One commercially available enzyme immunoassay system for the direct detection of gonococci in clinical material, called Gonozyme (Abbott Laboratories, North Chicago, 111. ), has been reported to give good correlation with culture results (1,3,6,11,21,26,27).…”

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confidence: 71%

Evaluation of a prototype DNA probe test for the noncultural diagnosis of gonorrhea

Granato

Franz

1989

J Clin Microbiol

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A prototype, nonisotopic, chemiluminescent DNA probe test called the Gen-Probe PACE (Probe Assay-Chemiluminescence Enhanced) system for Neisseria gonorrhoeae (Gen-Probe, San Diego, Calif.) was compared with conventional Martin-Lewis culture medium in JEMBEC plates for the laboratory diagnosis of gonorrhea. This 2-h noncultural assay is based upon the use of an acridinium ester-labeled DNA probe. The rRNA-directed DNA probe hybridizes with the target rRNA, and the hybridized probe is separated from the unhybridized probe through the use of magnetic microparticles. The esterifled acridinium is hydrolyzed from the hybridized probe by the addition of an alkaline hydrogen peroxide solution, resulting in the production of visible light which is measured in a luminometer. The amount of light generated is directly proportional to the amount of gonococcal target rRNA present in the sample. A total of 407 clinical specimens (203 urethral and 204 endocervical) were collected from high-risk walk-in patients attending a sexually transmitted disease clinic. Separate patient specimens were collected for culture on Martin-Lewis medium in JEMBEC plates and for DNA probe assay. Statistical analysis of the overall comparative results showed that the DNA probe assay had a sensitivity, specificity, and positive and negative predictive values of 93, 99, 97, and 99%, respectively, in a patient population with a gonococcal disease prevalence of 21 %. The results of this comparative study showed that the prototype chemiluminescent DNA probe assay is a rapid and reliable noncultural alternative for the laboratory diagnosis of gonorrhea.

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confidence: 71%

Evaluation of a prototype DNA probe test for the noncultural diagnosis of gonorrhea

Granato

Franz

1989

J Clin Microbiol

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“…[18][19][20][21][22] The number of false positive results that this would produce, particularly in low prevalence populations,22 has led to concern and consequently limited the use of the test.…”

Section: Diagnosis Of Neisseria Gonorrhoeaementioning

confidence: 99%

Neisseria gonorrhoeae: a versatile pathogen.

Easmon

Ison

1987

J Clin Pathol

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SUMMARY Neisseria gonorrhoeae is one of the most important causes of sexually transmitted disease. We do not fully understand the pathogenesis of infection with this organism, although recent improvements in immunological and molecular techniques have brought us closer to an answer.These techniques are now also being used to detect and identify Ngonorrhoeae and to analyse the epidemiology ofgonorrhoea. Plasmid and chromosomal mediated antibiotic resistance increases the difficulty of controlling gonorrhoea. Resistant strains occur all over the world and new patterns of resistance are still emerging.

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“…Noncultural techniques for diagnosing sexually transmitted diseases and, in particular, chlamydial and gonorrheal infections are now widely used. Such techniques are largely based on either immunofluorescence microscopy, enzyme immunoassay (1,3,12,14), or nucleic acid hybridization (4,10,11,15). These nonculture methods offer several advantages over conventional culture procedures in that the diagnosis is not dependent on the presence of viable microorganisms for microbial isolation and that turnaround times can be significantly reduced.…”

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confidence: 99%

Value of a DNA probe assay (Gen-Probe) compared with that of culture for diagnosis of gonococcal infection

et al. 1993

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The Gen-Probe PACE 2 system for Neisseria gonorrhoeae (GP), which uses a chemiluminescently labeled DNA probe, was compared with conventional culture as the method of reference. A total of 1,750 specimens were collected from 496 females and 623 males visiting the outpatient clinic of the Sexually Transmitted Diseases Department of the Westeinde Hospital, The Hague, The Netherlands, during the year 1991. The prevalences of gonorrhea culture-positive men and women were 14.9 and 7.7%o, respectively. The overall positive rate was 8.7%. Sensitivity, specificity, and positive and negative predictive values of GP were 97.1, 99.1, 90.6, and 99.8%, respectively. A total of 12 of 13 patients with positive GP results and negative cultures may have had a gonococcal infection, a conclusion based on clinical symptoms, positive methylene blue smears, and high relative light unit ratios. The DNA probe test can be useful as a suitable screening and diagnostic test for gonorrheal infection in men and women. An advantage of using this DNA probe technique is that simultaneous testing for Chlamydia trachomatis of the same specimen is possible. We also examined whether (all) rRNA had disappeared after adequate treatment for gonococcal and/or chlamydial infection in 30 patients. None of those positive patients showed a positive result in the DNA probe assay after treatment.

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A Preliminary Evaluation of the Gonozyme® Test

Cited by 17 publications

References 9 publications

Evaluation of a prototype DNA probe test for the noncultural diagnosis of gonorrhea

Evaluation of a prototype DNA probe test for the noncultural diagnosis of gonorrhea

Neisseria gonorrhoeae: a versatile pathogen.

Value of a DNA probe assay (Gen-Probe) compared with that of culture for diagnosis of gonococcal infection

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