Use, Safety Assessment, and Implementation of Two Point-of-Care Tests for COVID-19 Testing.

OBJECTIVES: The Abbot ID NOW COVID-19 assay and Quidel Sofia 2 SARS Antigen FIA are point-of-care assays that offer rapid testing for severe acute respiratory syndrome coronavirus 2 viral RNA and nucleocapsid protein, respectively. Given the utility of these devices in the field, we investigated the feasibility and safety of using the ID NOW and Sofia assays in the public health response to the coronavirus disease 2019 pandemic and in future public health emergencies. METHODS: A combination of utilization and contamination testing in addition to a review of instrument workflows was conducted. RESULTS: Utilization testing demonstrated that both tests are intuitive, associated with high user test success (85%) in our study, and could be implemented by staff after minimal training. Contamination tests revealed potential biosafety concerns due to the open design of the ID NOW instrument and the transfer mechanisms with the Sofia. When comparing the workflow of the ID NOW and the Sofia, we found that the ID NOW was more user-friendly and that the transfer technology reduces the chance of contamination. CONCLUSIONS: The ID NOW, Sofia, and other emerging point-of-care tests should be used only after careful consideration of testing workflow, biosafety risk mitigations, and appropriate staff training.

Two Imported Cases of Congenital Rubella Syndrome and Infection-Control Challenges in New York State, 2013-2015.

Rubella was declared eliminated in the United States in 2004. During 2013-2015, 2 infants with congenital rubella syndrome (CRS) were born in New York State. Both mothers were foreign born and traveled to Yemen during their pregnancy. Delayed consideration of CRS led to preventable exposures and a substantial public health response.

Notes from the Field: Increase in Reported Hepatitis A Infections Among Men Who Have Sex with Men - New York City, January-August 2017.

Since 2011, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has typically been notified of three or fewer cases of hepatitis A virus (HAV) infection each year among men who have sex with men (MSM) who reported no travel to countries where HAV is endemic. This year, DOHMH noted an increase in HAV infections among MSM with onsets in January-March 2017, and notified other public health jurisdictions via Epi-X, CDC's communication exchange network. As a result, 51 patients with HAV infection involving MSM were linked to the increase in NYC.

Giardiasis Outbreak Associated with Asymptomatic Food Handlers in New York State, 2015.

Giardia duodenalis is a protozoan that causes a gastrointestinal illness called giardiasis. Giardiasis outbreaks in the United States are most commonly associated with waterborne transmission and are less commonly associated with food, person-to-person, and zoonotic transmission. During June to September 2015, an outbreak of 20 giardiasis cases occurred and were epidemiologically linked to a local grocery store chain on Long Island, New York. Further investigation revealed three asymptomatic food handlers were infected with G. duodenalis, and one food handler and one case were coinfected with Cryptosporidium spp. Although G. duodenalis was not detected in food samples, Cryptosporidium was identified in samples of spinach dip and potato salad. The G. duodenalis assemblage and subtype from one of the food handlers matched two outbreak cases for which genotyping could be performed. This outbreak highlights the potential role of asymptomatically infected food handlers in giardiasis outbreaks.

Point mutations in the inc antisense RNA gene are associated with increased plasmid copy number, expression of blaCMY-2 and resistance to piperacillin/tazobactam in Escherichia coli.

BACKGROUND: High-level expression of AmpC ß-lactamase genes is associated with increased resistance to ß-lactam antibiotics. bla(CMY-2) is the most prevalent plasmid-encoded AmpC gene found in Escherichia coli worldwide, and the gene is often found on plasmids of the IncI1 replicon type. Replication of IncI1 plasmids is controlled by antisense RNA transcribed from the gene inc, and nucleotide changes in the hairpin loop region of inc have been associated with increased plasmid copy number of IncI1 mini-plasmid constructs. The objective of this study was to determine the mechanism(s) responsible for increased bla(CMY-2) expression in three piperacillin/tazobactam-selected E. coli mutant strains with bla(CMY-2) encoded on a 100 kb IncI1 plasmid. METHODS: Mutants were selected from a clinical E. coli strain by exposure to superinhibitory concentrations of piperacillin/tazobactam. ß-Lactam susceptibilities were measured by agar dilution. Relative bla(CMY-2) transcript levels, gene copy number and IncI1 plasmid copy number were measured by real-time PCR. The inc gene of all strains was sequenced. RESULTS: Piperacillin/tazobactam MICs were 16- to 128-fold higher for mutant strains than for their parent strain. This increase in MICs correlated with 3- to 13-fold increases in bla(CMY-2) gene expression, bla(CMY-2) copy number and IncI1 plasmid copy number. Two mutants with 8- and 13-fold increases in IncI1 copy number had single point mutations located within the hairpin loop region of inc. CONCLUSIONS: These findings demonstrate that inc point mutations can be associated with increased copy number of a 100 kb IncI1 plasmid, and lead to increased bla(CMY-2) expression and piperacillin/tazobactam resistance.

Association of IS5 with divergent tandem blaCMY-2 genes in clinical isolates of Escherichia coli.

OBJECTIVE: To characterize a unique tandem bla(CMY-2) gene arrangement found in two non-identical clinical strains of Escherichia coli. METHODS: Both plasmid and chromosomal DNA were evaluated using PFGE, restriction digest analysis, plasmid profiling and Southern hybridization. bla(CMY-2) gene expression and gene copy number were evaluated by real-time PCR. Susceptibilities to selected ß-lactam antibiotics were determined by agar dilution. RESULTS: A tandem arrangement for bla(CMY-2) was identified in both isolates and was the only arrangement for bla(CMY-2) observed. These isolates had distinct PFGE and plasmid profiles. Each strain exhibited 2-fold higher bla(CMY-2) mRNA expression and up to 8-fold lower ß-lactam susceptibility compared with a strain with a single copy of bla(CMY-2). CONCLUSION: This is the first report of IS5 being associated with tandem bla(CMY-2). IS5 has previously been associated with antibiotic resistance through tandem gene amplification. The unique tandem arrangement provides a mechanism for increased bla(CMY-2) expression.

bla(KPC) RNA expression correlates with two transcriptional start sites but not always with gene copy number in four genera of Gram-negative pathogens.

Klebsiella pneumoniae carbapenemase (KPC)-producing organisms are therapeutically and diagnostically challenging. It is possible that bla(KPC) gene expression plays a role in the variability observed in clinical susceptibility testing. bla(KPC) transformants together with 10 clinical isolates representing four genera were evaluated for bla(KPC) copy number and gene expression and correlated with ß-lactam MIC data. The data suggest that mechanisms other than gene copy number and expression of bla(KPC) contribute to variability in susceptibility when testing KPC-producing isolates.

Phenotypic and enzymatic comparative analysis of the novel KPC variant KPC-5 and its evolutionary variants, KPC-2 and KPC-4.

A novel Klebsiella pneumoniae carbapenemase (KPC) variant, designated bla(KPC-5), was discovered in a carbapenem-resistant Pseudomonas aeruginosa clinical isolate from Puerto Rico. Characterization of the upstream region of bla(KPC-5) showed significant differences from the flanking regions of other bla(KPC) variants. Comparison of amino acid sequences with those of other KPC enzymes revealed that KPC-5 was an intermediate between KPC-2 and KPC-4, differing from KPC-2 by a single amino acid substitution (Pro(103)-->Arg), while KPC-4 contained Pro(103)-->Arg plus an additional amino acid change (Val(239)-->Gly). Transformation studies with an Escherichia coli recipient strain showed differences in the properties of the KPC variants. KPC-4 and KPC-5 both had pIs of 7.65, in contrast with the pI of 6.7 for KPC-2. KPC-2 transformants were less susceptible to the carbapenems than KPC-4 and KPC-5 transformants. These data correlated with higher rates of imipenem hydrolysis for KPC-2 than for KPC-4 and KPC-5. However, KPC-4 and KPC-5 transformants had higher ceftazidime MICs, and the enzymes from these transformants had slightly better hydrolysis of this drug than KPC-2. KPC-4 and KPC-5 were more sensitive than KPC-2 to inhibition by clavulanic acid in both susceptibility testing and hydrolysis assays. Thus, KPC enzymes may be evolving through stepwise mutations to alter their spectra of activity.