Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices.

BACKGROUND: In the United States, human papillomavirus (HPV) and Papanicolaou (Pap) testing (cotesting) for cervical screening in women ages 30 to 65 years is the preferred strategy, and cytology alone is acceptable. Recently, a proprietary automated test for identifying high-risk HPV types for primary cervical screening was approved by the US Food and Drug Administration. The objective of the current study was to document extensive cervical screening among these screening options. METHODS: To investigate the sensitivity of various testing options for biopsy-proven cervical intraepithelial neoplasia grade 3 or worse (≥ CIN3) and cancer, the authors reviewed 256,648 deidentified results from women ages 30 to 65 years at the time of cotest who had a cervical biopsy specimen obtained within 1 year of the cotest. RESULTS: A positive cotest result was more sensitive (98.8%; 4040 of 4090 cotests) for diagnosing ≥ CIN3 than either a positive HPV-only test (94%; 3845 of 4090 HPV-only tests) or a positive Pap-only test (91.3%; 3734 of 4090 Pap-only tests; P < .0001). A positive Pap-only result was more specific (26.3%; 66,145 of 251,715 Pap-only tests) for diagnosing ≥ CIN3 than a positive HPV-only test (25.6%; 64,625 of 252,556 HPV-only tests) or a positive cotest (10.9%; 27,578 of 252,558 cotests; P < .0001). Of 526 cervical cancers, 98 (18.6%) were HPV-only negative, 64 (12.2%) were Pap-only negative, and 29 (5.5%) were cotest negative. CONCLUSIONS: Compared with HPV-only testing, cotesting was more sensitive for the detection of ≥ CIN3 in women ages 30 to 65 years. The current data suggest that approximately 19% of women with cervical cancer may be misdiagnosed by an HPV-only cervical screen. It is important to consider these data as the guidelines for cervical cancer screening undergo revision. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Use of rapid HIV assays as supplemental tests in specimens with repeatedly reactive screening immunoassay results not confirmed by HIV-1 Western blot.

BACKGROUND: An alternate HIV testing algorithm has been proposed which includes a fourth-generation immunoassay followed by an HIV-1/HIV-2 antibody differentiation supplemental test for reactive specimens and a nucleic acid test (NAT) for specimens with discordant results. OBJECTIVE: To evaluate the performance of five rapid tests (Alere Clearview, Bio-Rad Multispot, OraSure OraQuick, MedMira Reveal, and Trinity Biotech Unigold) as the supplemental antibody assay in the algorithm. STUDY DESIGN: A total of 3273 serum and plasma specimens that were third-generation immunoassay repeatedly reactive and Western blot (WB) negative or indeterminate were tested with rapid tests and NAT. Specimens were classified by NAT: (1) HIV-1 infected (NAT-reactive; n=184, 5.6%), (2) HIV-status unknown (NAT nonreactive; n=3078, 94.2%) or by Multispot, (3) HIV-2 positive (n=5), and (4) HIV-1 and HIV-2 positive (n=6). Excluding HIV-2 positive specimens, we calculated the proportion of reactive rapid tests among specimens with reactive and nonreactive NAT. RESULTS: The proportion of infected specimens with reactive rapid test results and negative or indeterminate WB ranged from 30.4% (56) to 47.8% (88) depending on the rapid test. From 1% to 2% of NAT-negative specimens had reactive rapid test results. CONCLUSIONS: In these diagnostically challenging specimens, all rapid tests identified infections that were missed by the Western blot, but only Multispot could differentiate HIV-1 from HIV-2. Regardless of which rapid test is used as a supplemental test in the alternative algorithm, false-positive algorithm results (i.e., reactive screening and rapid test in uninfected person) may occur, which will need to be resolved during the baseline medical evaluation.

Blood cholesterol trends 2001-2011 in the United States: analysis of 105 million patient records.

OBJECTIVES: We report annual trends in low density lipoprotein cholesterol (LDL-C) from an in-care patient population of nearly 105 million adults across the United States (U.S.), from 2001 through 2011. BACKGROUND: Average blood cholesterol values have declined in the U.S. since at least 1960. The National Health and Nutrition Examination Survey (NHANES) reported declining blood cholesterol values from 1999 through 2010. In the absence of more recent published data, we examined LDL-C values from a single clinical laboratory database to determine whether these values continued to decline through 2011. METHODS AND RESULTS: We extracted almost 247 million LDL-C results from nearly 105 million adults who received diagnostic testing from a single national clinical laboratory. Annual age-adjusted mean LDL-C values were calculated, and analyzed by gender. Piecewise regression analysis of the total study population indicates a breakpoint, or change in slope, in the years following 2008 (F = 163.13; p<0.05). Between 2001 and 2008, the average rate of annual decline was -2.05 mg/dL (95% CI [-2.35, -1.75]). After 2008, mean LDL-C levels flattened out, with a slope not statistically different from zero (slope = -0.10 mg/dL/year; 95% CI [-1.46, 1.26]). This stabilization was observed in both genders and all age ranges, and was also reflected in the percentage of results in low- and high-risk categories. CONCLUSIONS: The trends reported suggest historical progress in decreasing LDL-C levels, observed from 2001-2008, may have stalled in recent years. Further research is needed to determine the cause of the observed trends and develop new strategies to reduce lipid-based cardiovascular risk further.

Chlamydial and gonococcal testing during pregnancy in the United States.

OBJECTIVE: The objective of the study was to estimate the rates of testing, prevalence, and follow-up testing for chlamydial and gonococcal infection in a nationally based population that is comparable with the US pregnant population in terms of age and race. STUDY DESIGN: We extracted laboratory results for 1,293,423 pregnant women tested over a 3-year period. RESULTS: During pregnancy, 59% (761,315 of 1,293,423) and 57% (730,796 of 1,293,423) of women were tested at least once for Chlamydia trachomatis or for Neisseria gonorrhoeae, respectively. Of those women tested, 3.5% (26,437 of 761,315) and 0.6% (4605 of 730,796) tested positive for chlamydial and gonococcal infection, respectively, at least once during pregnancy. Of those women who were initially positive for the given infection, 78% (16,039 of 20,489) and 76% (2610 of 3435) were retested, of whom 6.0% (969 of 16,039) and 3.8% (100 of 2610) were positive on their last prenatal test for C trachomatis and N gonorrhoeae, respectively. CONCLUSION: Many pregnant women are not tested for C trachomatis and N gonorrhoeae despite recommendations to test. Follow-up testing to monitor the effectiveness of treatment is also not always performed.

National status of testing for hypothyroidism during pregnancy and postpartum.

CONTEXT: Hypothyroidism, overt or subclinical, is associated with adverse outcomes for pregnant women and their offspring. Knowledge of current national thyroid testing rates and positivity during pregnancy is limited. OBJECTIVE: The aim of the study was to estimate thyroid testing rate and positivity during pregnancy and postpartum, including testing and positivity rates of thyroperoxidase antibody (TPO Ab) and free T(4) tests in pregnant women with elevated TSH levels (hypothyroid), and in pregnant women having TSH within range (euthyroid). DESIGN AND SETTING: Records from a large, national sample of pregnant women screened from June 2005 through May 2008 were examined. PARTICIPANTS: The study included 502,036 pregnant women, for whom gestational age information was available. MAIN MEASURES: Testing rates and the prevalence of hypothyroidism during pregnancy and postpartum were measured using assay-specific, trimester-specific reference intervals. Screening and positivity rates of TPO Ab and free T(4) tests were also measured. RESULTS: Of women ages 18 to 40 yr, 23% (117,892 of 502,036) were tested for gestational hypothyroidism (defined as both subclinical and overt hypothyroidism). Of these, 15.5% (18,291 of 117,892) tested positive for gestational hypothyroidism. Twenty-four percent (22,650 of 93,312) of women with TSH within range and 33% (6,072 of 18,291) of women with elevated TSH were also tested for gestational hypothyroxinemia. Gestational hypothyroxinemia was seen in 0.2% (47 of 22,650) of the tested women with TSH within range and was seen in 2.4% (144 of 6,072) of the tested women having elevated TSH; 0.3% (276 of 93,312) of women with TSH within range received a TPO Ab test, and of these, 15% (41 of 276) tested positive; 0.66% (120 of 18,291) of women with elevated TSH received a TPO Ab test, and of these, 65% (78 of 120) tested positive. Only 20.7% (1873 of 9063) of hypothyroid women received thyroid screening within 6 months postpartum; of these, 11.5% (215 of 1873) were diagnosed with postpartum hypothyroidism. CONCLUSION: Gestational hypothyroidism is more common than generally acknowledged. Testing is not common, and test selection is variable. There is a low rate of postpartum follow-up.

Gaps in diabetes screening during pregnancy and postpartum.

OBJECTIVE: To estimate the screening rate and prevalence of gestational diabetes mellitus (GDM) and the screening rate and prevalence of postpartum diabetes, in a large, national sample of pregnant women. We also estimated the potential effects of the new International Association of Diabetes and Pregnancy Study Groups recommendations, which replace the 100-g oral glucose tolerance test (OGTT) with the 75-g OGTT, on GDM prevalence and gestational plasma glucose testing practices. METHODS: We identified pregnant women who used the laboratory services of Quest Diagnostics and who were screened for GDM and were tested postpartum. Gestational diabetes mellitus prevalence was calculated according to the current American Diabetes Association/ Carpenter-Coustan criteria, and the new International Association of Diabetes and Pregnancy Study Groups criteria. RESULTS: Sixty-eight percent (632,820/924,873) of pregnant women aged 25 to 40 (ie, those not in a low-risk age group) who utilized the services of Quest Diagnostics during this study were screened for GDM. Of the entire adult pregnant population (ages 18-40) who received GDM screening, 5% (40,955/842,993) had positive test results under the current criteria. Nineteen percent (4,486/23,299) of those with GDM received postpartum diabetes testing within a 6-month period. Ninety percent (148,749/166,085) of all confirmatory GDM tests performed on pregnant women at Quest Diagnostics were the 100-g OGTT. The number of women with GDM after receiving the 75-g OGTT would have doubled under the International Association of Diabetes and Pregnancy Study Groups criteria. CONCLUSION: Many women may not be receiving GDM screening during pregnancy. Postpartum diabetes screening rates after pregnancy remain low. Adoption of the new International Association of Diabetes and Pregnancy Study Groups criteria would require a significant change in current clinical practice. LEVEL OF EVIDENCE: III.