Personalized Cancer Monitoring Assay for the Detection of ctDNA in Patients with Solid Tumors.

Background: Highly sensitive molecular assays have been developed to detect plasma-based circulating tumor DNA (ctDNA), and emerging evidence suggests their clinical utility for monitoring minimal residual disease and recurrent disease, providing prognostic information, and monitoring therapy responses in patients with solid tumors. The Invitae Personalized Cancer Monitoring assay uses a patient-specific, tumor-informed variant signature identified through whole exome sequencing to detect ctDNA in peripheral blood of patients with solid tumors.

Methods: The assay's tumor whole exome sequencing and ctDNA detection components were analytically validated using 250 unique human specimens and nine commercial reference samples that generated 1349 whole exome sequencing and cell-free DNA (cfDNA)-derived libraries.

Investigation of Presumptive HIV Transmission Associated with Hospitalization Using Nucleotide Sequence Analysis - New York, 2017.

Since implementation of Standard Precautions* for the prevention of bloodborne pathogen transmission in 1985, health care-associated transmission of human immunodeficiency virus (HIV) in the United States has been rare (1). In October 2017, the New York City Department of Health and Mental Hygiene (NYCDOHMH) and the New York State Department of Health (NYSDOH) were notified by a clinician of a diagnosis of acute HIV infection in a young adult male (patient A) without recognized risk factors (i.e.

Phylodynamic Analysis Complements Partner Services by Identifying Acute and Unreported HIV Transmission.

Tailoring public health responses to growing HIV transmission clusters depends on accurately mapping the risk network through which it spreads and identifying acute infections that represent the leading edge of cluster growth. HIV transmission links, especially those involving persons with acute HIV infection (AHI), can be difficult to uncover, or confirm during partner services investigations. We integrated molecular, epidemiologic, serologic and behavioral data to infer and evaluate transmission linkages between participants of a prospective study of AHI conducted in North Carolina, New York City and San Francisco from 2011-2013.

Performance evaluation of the Bio-Rad Geenius HIV 1/2 supplemental assay.

Background: In the US, the HIV diagnostic algorithm for laboratory settings recommends the use of an HIV-1/HIV-2 differentiation supplemental assay after an initial reactive antigen/antibody (Ag/Ab) assay result. Since the discontinuation of the Multispot HIV-1/HIV-2 Rapid Test (MS), the Geenius HIV-1/2 Supplemental assay (Geenius) is the only FDA-approved supplemental differentiation test.

Objective: We compared the performance of Geenius to MS and Western Blot (WB).

Linking HIV and Viral Hepatitis Surveillance Data: Evaluating a Standard, Deterministic Matching Algorithm Using Data From 6 US Health Jurisdictions.

Accurate interpretations and comparisons of record linkage results across jurisdictions require valid and reliable matching methods. We compared existing matching methods used by 6 US state and local health departments (Houston, Texas; Louisiana; Michigan; New York, New York; North Dakota; and Wisconsin) to link human immunodeficiency virus and viral hepatitis surveillance data with a 14-key automated, hierarchical deterministic matching method. Applicable years of study varied by disease and jurisdiction, ranging from 1979 to 2016.

Frequency of Nucleic Acid Amplification Test Positivity Among Men Who Have Sex With Men Returning for a Test-of-Cure Visit 7 to 30 Days After Treatment of Laboratory-Confirmed Neisseria gonorrhoeae Infection at 2 Public Sexual Health Clinics, New York City, 2013 to 2016.

Background: The Centers for Disease Control and Prevention 2015 Sexually Transmitted Disease Treatment Guidelines recommend that clinicians consider cephalosporin treatment failure in patients who deny interval sexual exposure and are nucleic acid amplification test (NAAT) positive for Neisseria gonorrhoeae (NG) at least 7 days after adequate treatment. We evaluate the real-world implications of the interval the Centers for Disease Control and Prevention recommends for a NAAT test-of-cure (TOC), by ascertaining the frequency of NG NAAT positivity at different anatomic sites among men who have sex with men (MSM) at TOC 7 to 30 days after treatment.

Methods: We analyzed data from the medical records of MSM with laboratory-confirmed NG who were presumptively treated for NG during the period from June 2013 to April 2016 and returned for a TOC visit within 30 days.

Persons living with diagnosed HIV in New York City: over 50% over 50 years old.

Using NYC HIV surveillance data, we estimated the annual median age of persons living with diagnosed HIV (PLWDH) and the proportion of PLWDH over 50 years old in NYC between 2008 and 2015, and described the characteristics, retention in care and viral suppression status among PLWDH in NYC in 2015, by age (<50 vs. ≥50 years old). The median age of PLWDH in NYC increased from 46.

Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens.

Background: The Determine™ HIV-1/2 Ag/Ab Combo (DC) rapid test can identify HIV-1 infection earlier than rapid antibody-only tests in plasma specimens.

Objectives: We compared the performance of DC with a laboratory-based antigen/antibody (Ag/Ab) combo assay in plasma and evaluated antigen reactivity in whole blood specimens.

Study Design: We tested by DC 508 plasma specimens collected in a prospective study and 107 sequential plasma and simulated whole blood specimens from 20 seroconversion panels.

Diagnosing acute HIV infection: The performance of quantitative HIV-1 RNA testing (viral load) in the 2014 laboratory testing algorithm.

New recommendations for laboratory diagnosis of HIV infection in the United States were published in 2014. The updated testing algorithm includes a qualitative HIV-1 RNA assay to resolve discordant immunoassay results and to identify acute HIV-1 infection (AHI). The qualitative HIV-1 RNA assay is not widely available; therefore, we evaluated the performance of a more widely available quantitative HIV-1 RNA assay, viral load, for diagnosing AHI.

The Multispot rapid HIV-1/HIV-2 differentiation assay is comparable with the Western blot and an immunofluorescence assay at confirming HIV infection in a prospective study in three regions of the United States.

Background: A new HIV diagnostic algorithm has been proposed which replaces the use of the HIV-1 Western blot and HIV-1 immunofluorescence assays (IFA) as the supplemental test with an HIV-1/HIV-2 antibody differentiation assay.

Objectives: To compare an FDA-approved HIV-1/HIV-2 antibody differentiation test (Multispot) as a confirmatory test with the HIV-1 Western blot and IFA.

Study Design: Participants were screened with an HIV-1/HIV-2 combination Antigen/Antibody (Ag/Ab) screening assay.

Disparities in the severity of influenza illness: a descriptive study of hospitalized and nonhospitalized novel H1N1 influenza-positive patients in New York City: 2009-2010 influenza season.

Objective: To investigate the association between socioeconomic status (SES) and hospitalization for 2009 H1N1 influenza, independently of access to care and known risk factors for severe influenza illness, among New York City residents during the 2009-2010 influenza season.

Design: We used a 1:2 case-control study design, matching by age group and month of diagnosis. Cases were defined as laboratory-confirmed patients with 2009 H1N1 influenza who were hospitalized during their illness.

Evaluating the New York City Emergency Department Syndromic Surveillance for Monitoring Influenza Activity during the 2009-10 Influenza Season.

Objective: To use laboratory data to assess the specificity of syndromes used by the New York City emergency department (ED) syndromic surveillance system to monitor influenza activity.

Design: For the period from October 1, 2009 through March 31, 2010, we examined the correlation between citywide ED syndrome assignment and laboratory-confirmed influenza and respiratory syncytial virus (RSV). In addition, ED syndromic data from five select NYC hospitals were matched at the patient and visit level to corresponding laboratory reports of influenza and RSV.

Biostatistics.

Learning Objectives: After studying this article, the participant should be able to: 1. Recognize the various terms used in biostatistics. 2.

Mifepristone followed in 24 hours to 48 hours by misoprostol for late first-trimester abortion.

Objective: To investigate the efficacy of mifepristone and misoprostol for the termination of pregnancies in the late first trimester.

Methods: This was a prospective study of 321 women seeking termination of pregnancy with gestations from 64 days to 84 days (+/-3 days) by vaginal ultrasonography. Women were enrolled at three sites: University of Rochester Reproductive Health Program in Rochester, New York; Hung Vuong Hospital in Ho Chi Minh City, Vietnam; and K.

Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period.

Objective: Mifepristone-misoprostol medical abortion has been approved in the United States since 2000. U.S.

Acceptance of HIV testing among pregnant women in Dar-es-Salaam, Tanzania.

Background: Increased prevention of maternal-to-child transmission of HIV-1 has now become possible due to the availability of effective antiretroviral drugs in developing countries. It is necessary for pregnant women to know their HIV status in order to administer timely treatment to reduce transmission of the virus. This study assesses correlates of acceptance of testing for HIV infection in the antenatal setting in Dar-es-Salaam, Tanzania.