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Hologic ThinPrep 5000 Instruction Manual
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Hologic ThinPrep 5000 Instruction Manual

Hologic ThinPrep 5000 Instruction Manual

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ThinPrep
5000 Processor
 
 
 
 
 
 
 
 
 
 
 
 
 
Instructions for Use
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MAN-04008-001 Rev. 001
Page 1 of 27

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Summary of Contents for Hologic ThinPrep 5000

  • Page 1         ® ThinPrep 5000 Processor                           Instructions for Use                                 MAN-04008-001 Rev.
  • Page 2 At the laboratory, the PreservCyt sample vial is barcoded along with the test request form to establish a sample chain of custody and is placed into a ThinPrep 5000 processor. A glass slide bearing the same sample identification number as on the sample vial is loaded into the processor. A gentle dispersion step mixes the cell sample by currents in the fluid that are strong enough to separate debris and disperse mucus, but gentle enough to have no adverse effect on cell appearance.
  • Page 3   The PreservCyt Solution component of the ThinPrep 5000 system is also an alternative collection and transport medium for gynecologic specimens tested with the Roche Diagnostics COBAS AMPLICOR CT/NG assay. Refer to Hologic’s labeling (Document #MAN-02063-001) for instructions for using PreservCyt Solution for collection, transport, storage, and preparation of specimens and to the Roche Diagnostics COBAS AMPLICOR CT/NG package insert for instructions for use of that system.
  • Page 4    Supplies used by the ThinPrep 5000 processor are those designed and supplied by Hologic specifically for the ThinPrep 5000 processor. These include PreservCyt Solution vials, ThinPrep Pap test filters, and ThinPrep microscope slides. These supplies are required for proper performance of the system and cannot be substituted.
  • Page 5 ThinPrep 5000 processor are predicated on those of the ThinPrep 2000 system. Both the clinical studies for the ThinPrep 2000 system and those comparing the ThinPrep 5000 processor to the ThinPrep 2000 are described in the following sections.
  • Page 6   Pap smear slides were examined and diagnosed independently. Reporting forms containing patient history as well as a checklist of all possible categories of The Bethesda System were used to record the results of the screening. A single independent pathologist reviewed all discrepant and positive slides from all sites in a blinded fashion to provide a further objective review of the results.

  • Page 7: Table Of Contents

      Table 2: Diagnostic Classification Table, All Categories   Conventional     NEG ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL 5224 5593 ThinPrep   ASCUS   AGUS   LSIL     HSIL   SQ CA   GL CA  ...

  • Page 8: Ascus

      Table 5: Two Category Diagnostic Classification Table, ASCUS/AGUS and More Severe Diagnoses   Conventional     ASCUS/AGUS+ TOTAL     ThinPrep 5224 5593       ASCUS/   1154 AGUS+     TOTAL   5680 1067 6747     The diagnostic data analysis from the sites is summarized in Table 6 and 7.

  • Page 9: Lsil

      Table 7: Results by Site, ASCUS/AGUS and More Severe Lesions       ThinPrep Increased Method Convent. Site Cases p-Value ASCUS+ ASCUS+ Detection* Favored 1,336 0.067 Neither 1,563 <0.001 ThinPrep 1,058 <0.001 ThinPrep 0.007 ThinPrep 1,010 (8%) 0.360 Neither (9%) 0.102 Neither...
  • Page 10   Table 8: Independent Pathologist Results by Site, LSIL and More Severe Lesions         Cases   Site ThinPrep Conventional Method Positive by p-Value Independent Positive Positive Favored Pathologist         0.170 Neither        ...

  • Page 11: Hsil

      Table 10 below shows the summary for all sites of the descriptive diagnosis for all Bethesda System categories.   Table 10: Summary of Descriptive Diagnosis   Descriptive Diagnosis ThinPrep Conventional     Number of Patients: 6747 Benign Cellular Changes: 1592 23.6 1591...

  • Page 12: Total

      Table 11 shows the rates of detection for infection, reactive changes, and the total benign ® cellular changes for both the ThinPrep and conventional methods at all sites.   Table 11: Benign Cellular Changes Results       ThinPrep Conventional  ...
  • Page 13   Table 12: Summary of Specimen Adequacy Results     Specimen Adequacy ThinPrep Conventional   Number of Patients: 7223 Satisfactory 5656 78.3 5101 70.6 Satisfactory for Evaluation 1431 19.8 2008 27.8 but Limited by:         Air-Drying Artifact Thick Smear  ...
  • Page 14   Table 14: Specimen Adequacy Results by Site       ThinPrep Convent. ThinPrep Convent. ThinPrep Convent. Site Cases SBLB SBLB UNSAT UNSAT Cases Cases Cases Cases Cases Cases 1,386 1092 1178 1,668 1530 1477 1,093 1,046 1,049 All Sites 7,223 5656 5101...
  • Page 15 Direct-to-Vial HSIL+ Study   Following initial FDA approval of the ThinPrep system, Hologic conducted a multi-site direct-to- vial clinical study to evaluate the ThinPrep 2000 system versus conventional Pap smear for the detection of High Grade Squamous Intraepithelial and more severe lesions (HSIL+). Two types of patient groups were enrolled in the trial from ten (10) leading academic hospitals in major metropolitan areas throughout the United States.
  • Page 16 6 weeks of specimen collection.   All study specimens were processed both on a ThinPrep 5000 processor and a ThinPrep 2000 system. The order in which the slides were processed was alternated in blocks of 20. All slides were stained, coverslipped, and read manually following standard laboratory procedures;...

  • Page 17: Lsil

    Reference Diagnosis by Adjudication Review After all slides in the study were reviewed, all ThinPrep 2000 and ThinPrep 5000 slides were subject to an adjudication review. Adjudication was done at a facility that was not one of the study sites conducting the study.

  • Page 18: Lsil

    Tables 20 through 23 present the comparison of Laboratory true positive and negative rates for ASC-US+, LSIL+, ASC-H+, and HSIL+. Table 20: Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results for the Specimens with Reference Diagnosis of ASC-US+ In the study, there were 530 specimens with Reference Diagnosis of ASC-US+ (combined ASC-US, AGUS, LSIL, ASC-H, HSIL, and Cancer) and 696 specimens with Reference Diagnosis of NILM.
  • Page 19   Table 22: Laboratory ThinPrep 5000 Results vs Laboratory ThinPrep 2000 Results for the Specimens with Reference Diagnosis of ASC-H+ In the study, there were 185 specimens with Reference Diagnosis of ASC-H+ (combined ASC-H, HSIL, and Cancer) and 1,041 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, and LSIL).

  • Page 20: Total

    The following tables indicate the extent to which the laboratory cytotechnologists / pathologists at a given site agreed amongst themselves on the diagnosis, comparing the ThinPrep 5000 processor to the ThinPrep 2000 system. Tables are provided for ASC-US+ and ASC-H+.
  • Page 21   The rate of agreement between the ThinPrep 5000 result and the ThinPrep 2000 result from the previous table is presented below. PPA is the positive percent agreement, percent of specimens of ASC-H+ diagnosis with ThinPrep 5000 slides by a majority of laboratory CT/Pathologists among all specimens of ASC-H+ diagnosis with ThinPrep 2000 slides by a majority of laboratory CT/Pathologists.
  • Page 22     The rate of agreement between the ThinPrep 5000 result and the ThinPrep 2000 result from the previous table is presented below. PPA is the positive percent agreement, percent of specimens of ASC-US+ diagnosis with ThinPrep 5000 slides by a majority of laboratory CT/Pathologists among all specimens of ASC-US+ diagnosis with ThinPrep 2000 slides by a majority of laboratory CT/Pathologists.
  • Page 23 Within-Instrument Precision   The study was designed to examine the ability of the ThinPrep 5000 system to prepare reproducible slides from the same patient specimen using the same instrument. A total of 80 specimens were enrolled in the study. Each specimen was split into three portions and processed on three separate runs of one instrument.
  • Page 24 Two hundred ten (210) specimens were enrolled in the study (139 NILM, 28 ASC-US, 28 LSIL, and 15 HSIL). Each specimen was split into two parts, processed on a ThinPrep 2000 and ThinPrep 5000 system, then stained and coverslipped. All slides were run on a ThinPrep Imaging System to obtain Imager object count data, which has been demonstrated to correlate closely with cytotechnologist cell count estimates.
  • Page 25 Considering the technological similarity to the ThinPrep 2000 system and the comparative clinical and analytical study results, it is concluded that the ThinPrep 5000 processor is similar to the ThinPrep 2000 processor and may be used as a replacement for the conventional Pap smear method for the detection of atypical cells, cervical cancer, or its precursor lesions, as well as all other cytologic categories as defined by The Bethesda System.
  • Page 26 MATERIALS REQUIRED   Materials Provided ThinPrep 5000 Processor    ThinPrep 5000 processor instrument    ThinPrep 5000 Processor Operator’s Manual    Fixative baths with evaporation covers (3)    Carousel (1)    Waste bottle assembly - includes bottle, bottle cap, tubing set, fittings, waste filter  ...
  • Page 27 Liquid-based, thin-layer preparation vs. conventional Pap smear. Acta Cytol 2002; 46: 453-7     TECHNICAL SERVICE AND PRODUCT INFORMATION For technical service and assistance related to use of the ThinPrep 5000 processor, contact Hologic: Telephone: 1-800-442-9892 Fax: 1-508-229-2795 For international or toll-free blocked calls, please contact 1-508-263-2900.