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Bacteriology

An Internal Control for Routine Diagnostic PCR: Design, Properties, and Effect on Clinical Performance

Maurice Rosenstraus, Zhuang Wang, Sheng-Yung Chang, David DeBonville, Joanne P. Spadoro
Maurice Rosenstraus
Roche Molecular Systems, Branchburg, New Jersey 08876
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Zhuang Wang
Roche Molecular Systems, Branchburg, New Jersey 08876
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Sheng-Yung Chang
Roche Molecular Systems, Branchburg, New Jersey 08876
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David DeBonville
Roche Molecular Systems, Branchburg, New Jersey 08876
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Joanne P. Spadoro
Roche Molecular Systems, Branchburg, New Jersey 08876
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DOI: 10.1128/JCM.36.1.191-197.1998
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    Fig. 1.

    Effect of increasing concentration of target nucleic acid on IC signal. Samples containing increasing amounts of C. trachomatis (CT) target DNA, 25 copies of N. gonorrhoeae (NG) target DNA, and 20 copies of IC DNA per test sample were amplified in a Perkin-Elmer 9600 thermal cycler.C. trachomatis, N. gonorrhoeae, and IC amplification products were hybridized to separate microwell plates coated with target-specific oligonucleotide probes. The hybridized amplification products were detected colorimetrically with an avidin-horseradish peroxidase complex. The concentration of C. trachomatis target DNA is shown on the x axis (1.00E+01 is 101, 1.00E+02 is 102 etc.) and the absorbance at 450 nm is shown on the y axis. The broken line indicates the assay cutoff value.

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    Fig. 2.

    Distribution of IC signals in a set of clinical specimens. Specimens were tested by the COBAS AMPLICOR C. trachomatis and N. gonorrhoeae tests. The IC signal was evaluated in specimens that were negative for both C. trachomatis and N. gonorrhoeae. Each bar shows the number of specimens (on the y axis) having an IC absorbance less than the value the value shown directly below the bar (on thex axis) but greater than or equal the value to the immediate left (on the x axis). The bar over the 4.00 value includes specimens having signals equal to 4.00.

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    Fig. 3.

    Effect of IC cutoff on assay sensitivity. A set of clinical specimens was tested with the COBAS AMPLICOR C. trachomatis test. Different IC cutoff values were used to distinguish between inhibitory and noninhibitory specimens. Clinical sensitivity and the number of inhibitory, infection-positive specimens were calculated for each cutoff value. The IC cutoff is shown on thex axis, clinical sensitivity is shown on the lefty axis, and the number of inhibitory specimens is shown on the right y axis.

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  • Table 1.

    Frequency of inhibition in infection-positive and -negative specimens

    COBAS AMPLICOR test and specimenInfection-positive specimensInfection-negative specimens
    Total no.No. inhibitory (%)RetestTotal no.No. inhibitory (%)Retest
    No. positiveNo. inhibitoryNo. negativeNo. inhibitory
    C. trachomatis
     Swab1174 (3.4)1383982a (9.8)2246
     Urine1187 (5.9)6184779b (9.3)689
    N. gonorrhoeae
     Swab1151 (0.9)1083163c (7.6)2438
     Urine1188 (6.8)6283670d (8.4)626
    M. tuberculosis
     Smear positive1541 (0.6)10290  (0.0)00
     Smear negative1253 (2.4)124,068217  (5.3)96121
    HCV1,03661 (5.9)5011929107  (11.5)989
    • ↵a Fourteen of the inhibitoryC. trachomatis swab specimens were not available for retesting.

    • ↵b Two of the inhibitory C. trachomatis urine specimens were not available for retesting.

    • ↵c One of the inhibitory N. gonorrhoeae swab specimens was not available for retesting.

    • ↵d Two of the inhibitory N. gonorrhoeae urine specimens were not available for retesting.

  • Table 2.

    Enhancement of test sensitivity using IC

    COBAS AMPLICOR test and specimenSensitivity (%)Specificity (%)
    Without ICWith ICWithout ICWith IC
    C. trachomatis
     Swab94.8 (110/116)97.4 (111/114)99.0 (832/840)99.0 (771/779)
     Urine92.0 (104/113)94.0 (110/117)99.1 (844/852)99.0 (828/836)
    N. gonorrhoeae
     Swab93.9 (108/115)94.8 (109/115)98.0 (814/831)97.9 (775/792)
     Urine83.8 (98/117)89.7 (104/116)98.9 (828/837)98.8 (818/828)
    M. tuberculosis
     Smear positive98.7 (151/153)98.7 (152/154)90.0 (27/30)89.7 (26/29)
     Smear negative73.6 (92/125)75.6 (93/123)99.0 (4027/4068)99.0 (3906/3947)
    HCV72.6 (752/1036)78.2 (802/1025)98.2 (912/929)98.2 (903/920)
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An Internal Control for Routine Diagnostic PCR: Design, Properties, and Effect on Clinical Performance
Maurice Rosenstraus, Zhuang Wang, Sheng-Yung Chang, David DeBonville, Joanne P. Spadoro
Journal of Clinical Microbiology Jan 1998, 36 (1) 191-197; DOI: 10.1128/JCM.36.1.191-197.1998

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An Internal Control for Routine Diagnostic PCR: Design, Properties, and Effect on Clinical Performance
Maurice Rosenstraus, Zhuang Wang, Sheng-Yung Chang, David DeBonville, Joanne P. Spadoro
Journal of Clinical Microbiology Jan 1998, 36 (1) 191-197; DOI: 10.1128/JCM.36.1.191-197.1998
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polymerase chain reaction

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