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29 protocols using aptima

1

Multiplex STI Screening by Aptima Assays

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Three Aptima (Hologic, San Diego, CA) assays were performed from a single endocervical specimen on the Panther (Hologic San Diego, CA) platform: Aptima Combo 2 (AC2) for CT and NG [11 (link), 12 (link)], Aptima TV (ATV) [13 (link)], and Aptima MG (AMG) [14 (link)].
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2

HPV Self-Sampling and Physician-Collected Procedures

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The study process is illustrated in the study scheme (Fig. 1). On the day of the scheduled colposcopy, data obtained from the women included baseline characteristics, obstetric and gynecological history, and history of cervical cancer screening and its results. The research assistant then played a 5-minute video along with pictorial instructions about the self-sampling procedure. All questions were addressed verbally until all steps were clearly understood. Attitudes toward HPV self-sampling were assessed using the self-answered Q-A. The women then proceeded to collect samples with self-sampling tools for hrHPV mRNA (Aptima®; Hologic, Inc., San Diego, CA, USA) and HPV DNA testing (cobas® 4800 Systems; Roche Diagnostic Inc., Bangkok, Thailand). As the illustrated instruction (Supplementary Fig. 1). The colposcopy was then undertaken by a gynecologic oncologist who thoroughly examined the cervix before collecting the cervical specimen for cytology and HPV mRNA testing (Aptima®; Hologic, Inc.). Subsequently, the attitude toward HPV self-sampling, with an additional question about pain and discomfort compared to the physician-collected procedure, was reassessed using Q-B.
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3

Sexually Transmitted Infection Screening Protocol

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First-void urine was collected and routinely tested for NG and CT (Aptima Combo 2; Hologic Inc, San Diego, CA). Samples with equivocal results were retested using the Aptima CT single assay (Hologic Inc) and for NG with a quantitative polymerase chain reaction targeting opa genes.17 (link) Urine samples were tested for MG using transcription-mediated amplification (TMA) assays (Aptima, Hologic Inc). From all samples that tested positive for MG in the MG-TMA assay, DNA was extracted with isopropanol precipitation and subsequently tested for macrolide resistance using the MG-MRAM quantitative polymerase chain reaction to detect wild-type (MG-WT) or any mutations (MRAM) in the 23S rRNA gene at nucleotide positions 2058 and 2059 (Escherichia coli numbering).18 (link)Mycoplasma genitalium and MRAM testing were done for study purposes only, and results were disclosed neither to the men nor to the healthcare professionals. A subset of samples was tested for Trichomonas vaginalis (TV) using TMA assays (Aptima, Hologic Inc).
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4

Chlamydia Diagnosis Sensitivity Analysis

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All testing during the study period used the highly sensitive C trachomatis NAAT on urogenital samples. The UAB Obstetrics and Gynecology Diagnostic Laboratory tested outpatient samples using Roche Amplicor (Roche Diagnostics, Indianapolis, IN) in 2011–2012, and Roche COBAS 4800 in 2013–2017. The main UAB laboratory tested samples collected in the emergency room and inpatient setting using BD Viper (BD Diagnostic Systems, Sparks, MD) in 2011–2014 and Hologic Aptima (Hologic, San Diego, CA) in 2014–2017. The sensitivity of various NAAT tests performed for C trachomatis in this study ranges from 90% to 98% with specificity of >99% and similar performance characteristics for all sample sites (vaginal, cervical, and urine).28 (link)-31
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5

Chlamydia Diagnosis Sensitivity Analysis

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All testing during the study period used the highly sensitive C trachomatis NAAT on urogenital samples. The UAB Obstetrics and Gynecology Diagnostic Laboratory tested outpatient samples using Roche Amplicor (Roche Diagnostics, Indianapolis, IN) in 2011–2012, and Roche COBAS 4800 in 2013–2017. The main UAB laboratory tested samples collected in the emergency room and inpatient setting using BD Viper (BD Diagnostic Systems, Sparks, MD) in 2011–2014 and Hologic Aptima (Hologic, San Diego, CA) in 2014–2017. The sensitivity of various NAAT tests performed for C trachomatis in this study ranges from 90% to 98% with specificity of >99% and similar performance characteristics for all sample sites (vaginal, cervical, and urine).28 (link)-31
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6

Molecular detection of STIs

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Aptima (Hologic) swabs were transported on ice and stored at 4°C for <30 days until testing by the Aptima Combo 2 for chlamydia and gonorrhea, by Aptima TV for trichomonas, and by Aptima MG for Mycoplasma genitalium.
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7

Immune response kinetics after COVID-19 infection and vaccination

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Anonymized blood samples were collected at the Virology laboratory, Toulouse University Hospital before the first Delta variant infections appeared and were biobanked at the hospital Biological Resource Center (certified to NF 596-900 standards). This study was approved by the French Research Ethics Committee Est-111 (COVID BioToul ID-RCB 2020-AO1292-37; ClinicalTrials.gov registration number NCT04385108).
To ensure consistency of the kinetics of the immune response, we used blood samples collected 1 to 3 months postinfection among the nonvaccinated (19 (link)) and 1 month after the last injection among the vaccinated HCWs. Blood samples from unvaccinated health care workers (n = 162) who had an infection documented by nucleic acid testing of a nasopharyngeal sample (Aptima; Hologic, USA) (26 (link)) were collected in July 2020, i.e., 1 to 3 months postinfection in this cohort (27 (link)). Samples were collected from vaccinated health care workers (n = 263) at the antibody peak following vaccination, i.e., 1 month after the last injection. A total of 217 vaccinated health care workers (HCWs) were seronegative for SARS-CoV-2 prior to vaccination. Of these, 105 (48.4%) were vaccinated with BNT162b2/BNT162b2, 94 (43.3%) with ChAdOx1-S/BNT162b2, and 18 (8.3%) with ChAdOx1-S/ChAdOx1-S. The remaining 46 HCWs were seropositive for SARS-CoV-2 prevaccination and were all given BNT162b2.
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8

Immune response kinetics after COVID-19 infection and vaccination

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Anonymized blood samples were collected at the Virology laboratory, Toulouse University Hospital before the first Delta variant infections appeared and were biobanked at the hospital Biological Resource Center (certified to NF 596-900 standards). This study was approved by the French Research Ethics Committee Est-111 (COVID BioToul ID-RCB 2020-AO1292-37; ClinicalTrials.gov registration number NCT04385108).
To ensure consistency of the kinetics of the immune response, we used blood samples collected 1 to 3 months postinfection among the nonvaccinated (19 (link)) and 1 month after the last injection among the vaccinated HCWs. Blood samples from unvaccinated health care workers (n = 162) who had an infection documented by nucleic acid testing of a nasopharyngeal sample (Aptima; Hologic, USA) (26 (link)) were collected in July 2020, i.e., 1 to 3 months postinfection in this cohort (27 (link)). Samples were collected from vaccinated health care workers (n = 263) at the antibody peak following vaccination, i.e., 1 month after the last injection. A total of 217 vaccinated health care workers (HCWs) were seronegative for SARS-CoV-2 prior to vaccination. Of these, 105 (48.4%) were vaccinated with BNT162b2/BNT162b2, 94 (43.3%) with ChAdOx1-S/BNT162b2, and 18 (8.3%) with ChAdOx1-S/ChAdOx1-S. The remaining 46 HCWs were seropositive for SARS-CoV-2 prevaccination and were all given BNT162b2.
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9

SARS-CoV-2 Detection Across Diagnostic Assays

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Remnant nasopharyngeal or lateral midturbinate nasal clinical specimens that tested positive for SARS-CoV-2 after standard of care diagnostic or screening assays were performed across the Johns Hopkins Medical System (representing a wide geographic area in the National Capital Region—Maryland, Washington, DC, and Virginia). Different molecular assays are used for SARS-CoV-2 detection, including the NeuMoDx (Qiagen) [21 (link), 22 (link)], cobas (Roche) [21 (link)], Aptima (Hologic), Xpert Xpress SARS-CoV-2/Flu/RSV (Cepheid) [23 ], ePlex respiratory pathogen panel 2 (GenMark) [24 (link)], Accula, and RealStar SARS-CoV-2 assays (altona Diagnostics) [25 (link)]. Testing was performed in accordance with the manufacturer instructions and our in house validated protocols. Specimen selection was random except for cycle threshold (Ct), where values <20 were preferentially selected when available.
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10

STM Transport and Pathogen Detection

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The self-collected penile-meatal swabs were eluted in phosphate-buffered saline (PBS), frozen, and together with paired, frozen, urine samples sent to the Johns Hopkins University for additional testing. Two hundred microliters of the swab elution was placed in the multitest swab transport medium (STM). Urine samples (≈2 mL) were transferred to urine specimen transport tubes per manufacturer’s instructions. Swab and urine samples were tested for M. genitalium as well as Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis using the Aptima (Hologic, San Diego, CA, USA) M. genitalium transcription-mediated amplification-based Research Use Only, Combo 2 C. trachomatis/N. gonorrhoeae, and T. vaginalis assays, respectively. Samples with invalid Aptima C. trachomatis, N. gonorrhoeae, T. vaginalis, or M. genitalium results were retested; samples with repeated (tested twice) invalid Aptima results were excluded from the analysis.
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