Biomedical subjects

John A Maksem

Publications and source records attributed to John A Maksem.

4 recordsLinked to original sources

PubMed2006

Validation of a low-cost, liquid-based screening method for cervical intraepithelial neoplasia.

OBJECTIVE: The objective of the study was to validate a low-cost, liquid-based method for cervical cancer screening. STUDY DESIGN: We conducted a retrospective, split-sample comparison of 300 liquid-based cervical cytology samples from a group of 150 human immunodeficiency virus-seropositive women and 150 women from low-risk general gynecology clinics whose specimens were screened via standard liquid-based methodology as part of routine care. Residual samples from each specimen were used to prepare a slide using a novel, inexpensive manual membrane method of liquid-based cytology. These slides were screened by a cytotechnologist and abnormal cases were reviewed by a pathologist. Final diagnoses from the manual membrane method of liquid-based cytology slides were compared with the original diagnoses and available cervical biopsy data. RESULTS: There was good overall agreement between the manual membrane method of liquid-based cytology and original cytology diagnoses (76.3% agreement; kappa = 0.52, 95% confidence interval 0.44 to 0.59). Using available biopsy data to determine the accuracy of each method to identify high-grade squamous intraepithelial lesions, the manual membrane method of liquid-based cytology method was found to have a higher sensitivity (71.4% versus 57.1%) and lower specificity (82.1% versus 89.7%). The slightly higher referral rate to colposcopy using the manual membrane method of liquid-based cytology method was limited to women from the low-risk general gynecology clinics (16.7% versus 12.0%, P = .05). CONCLUSION: The low-cost manual membrane method of liquid-based cytology cervical cytology method is comparable with a standard commercial method. Consequently, it may be of value in alternative screening strategies in resource-limited settings.

Cytodiagnosis↗

PubMed2006

Endocervical curetting vs. endocervical brushing as case finding methods.

This paper focuses on the performance of endocervical curettage (ECC) and intensive endocervical brushing (ECB) (comprising two or more brushings of the endocervix with liquid-based cytology and cell-block examination) in the course of colposcopic examination for abnormal gynecological cytology. To assess their relative effectiveness in disease detection, we reviewed the outcomes of 1,824 colposcopic biopsy collections from women who had an index cytology diagnosis of LSIL or higher. Our intent was to gauge the relative success of ECC and ECB as case-finding procedures in relation to (1) the original cytological diagnosis and (2) the highest (most abnormal) histological diagnosis of the colposcopy study. Our purpose was to determine whether ECB could effectively replace ECC. One thousand five hundred and seven cases of LSILs or higher cases included an ECC along with two or more colposcopic biopsies and 317 cases included an ECB. ECBs were collected into a liquid fixative and processed as both cytology and cell-block specimens; whereas, ECCs were processed according to standard histological techniques. We found that intensive ECB recapitulates the highest diagnosis of the colposcopy study about 5-8 times as often as that of ECC. Moreover, when calculating the proportion of positive outcomes, we found that cases examined with biopsy and ECC discovered fewer women with CIN 2 or higher among both LSIL and HSIL index cytologies as compared with those of cases examined with biopsy and ECB (9.2% vs. 16.8% for LSIL and 63.7% vs. 72.2% for HSIL cases); and, more negative outcomes were seen among women evaluated with biopsy plus ECC than those with biopsy plus ECB (11.3% vs. 8.1% for LSIL and 4.7% vs. 1.4% for HSIL cases). Our findings suggest that the colposcopic study is optimized when it is performed in conjunction with ECB as opposed to ECC, and that intensive ECB may be superior to ECC.

Biopsy↗

PubMed2006

Testing automated liquid-based cytology samples with a manual liquid-based cytology method using residual cell suspensions from 500 ThinPrep cases.

We report a technical improvement upon a previously disclosed manual liquid-based cytology (MLBC) method; and, we use the improved method to prepare slides from residual ThinPrep specimens in order to see how often ThinPrep diagnoses correspond to diagnoses derived from exhaustive examination of their parent sample suspensions. Residual cell suspensions from 500 ThinPrep cases comprising (1) 20 low-grade squamous intraepithelial lesions (LSILs); (2) 200 high risk (HR) negatives and 20 ASC-US; and (3) 260 screening cytology specimens were studied. Institutional review committee guidelines allowed us to know diagnoses by groups of specimens, but did not allow us to know individual patient diagnoses, so we could not perform case-by-case matched outcome-comparisons. Cells were concentrated by conventional centrifugation and sedimented into a polymer gel that was then vortex-mixed and converted into a viscous cell-rich suspension. The cell suspension was smeared between two clean glass slides, which were air-dried and stained with the Papanicolaou stain. Two study-sets were created, comprising one slide from each case. Each of the two study sets was examined by two cytopathologists, and discordant diagnoses were adjudicated. Because of the ambiguity involved in the "atypical" (ASC-US, ASC-H, AGC) diagnosis categories, only outcomes at the level of LSIL or greater were recorded. All MLBC SILs were digitally imaged and abnormal slides plus digital images were sent to the laboratory that provided the residual automated liquid-based cytology (ALBC) suspensions. The final diagnoses were confirmed by the laboratory that provided the residual ALBC specimens. MLBC slides of the 20 LSIL cases afforded 2 high-grade squamous intraepithelial lesions (HSILs) and 18 LSILs. Those of the 200 HR-Negatives showed 3 HSILs and 30 LSILs; and those of the 20 HR-ASC-US showed 3 HSILs and 9 LSILs. MLBC slides of the 260 screening cytology specimens showed 1 Carcinoma, 3 HSILs and 20 LSILs; affording 3 HSILs and 14 LSILs more than originally diagnosed. The MLBC method of this report is useful for preparing cell suspensions for cytological examination. Our analytical method was exhaustive and used nearly all of the cell material that was provided to us for analysis; therefore, we conclude that this approach is useful for determining how well ALBC instruments represent their parent sample suspensions. It appears that "rare events" may be overlooked when limited sample aliquots are analyzed by ALBC instruments, and this probably accounts for our increased discovery of SILs by the MLBC method. Also, SILs often present as aggregates of cohesive cells which, if overlooked or ineffectively transferred to ALBC slides, would not be diagnosed.

Cytological Techniques↗

PubMed2005

Resolving ASCUS without recourse to HPV testing: manual reprocessing of residual automated liquid-based cytology (ALBC) material using manual liquid-based cytology (MLBC).

We show that residual cell material from ThinPrep PapTest (Cytyc Corporation, Boxborough, MA) atypical squamous-cells of undetermined significance (ASCUS) cases may be manually reprocessed to triage women into actionable diagnostic categories (HSIL, LSIL, and Negative). Material remaining from each of 358 ThinPrep ASCUS cases was manually reprocessed as two slides, labeled "A" and "B." Interobserver agreement between case contributors (CCs) and three sequential reviewers (SRs) was analyzed with 186 cases (Study 1), and diagnostic reproducibility between SRs was examined with an additional 172 cases (Study 2). In Study 1, CCs classified 33% of cases as LSIL or greater, SRs classified 60% as LSIL or greater, and there was 58% diagnostic agreement between CCs and SRs. No "Negative" case assignment by one group afforded an "HSIL" assignment by the complementary group. In Study 2, there was 95% agreement between SRs A slide and B slide diagnoses with 54% of A slides and 55% of B slides classified as LISL or greater. Again, no "Negative" case assignment to one slide afforded an "HSIL" assignment to the complementary slide. Overall, 12.6% of the 358 cases showed HSIL, and all HSILs by one observer group were ASCUS or greater by the complementary observer group. Using manual reprocessing beyond the 21-day specimen outdate for HPV testing by the Hybrid Capture II High Risk HPV test (HR-HCII; Digene Corporation, Beltsville, MD), many ThinPrep ASCUS cases were reclassified as LSIL or HSIL. The 12.6% HSIL proportion of this study approximated the 11.5% CIN 2 or greater proportion of the ALTS ASCUS arm. Similar to ALTS, manual liquid-based cytology (MLBC) would have referred nearly 60% of women to colposcopy for a definitive diagnosis of HSIL or LSIL without resorting to HPV testing. These data demonstrate that many cases of automated liquid-based cytology (ALBC)-diagnosed ASCUS represent unrecognized SIL, which is present in the ALBC specimen vial at the time the ASCUS diagnosis is rendered.

Carcinoma, Squamous Cell↗