RESUMEN
BACKGROUND AND OBJECTIVE: CINtec PLUS and cobas HPV tests (Roche) were previously ascertained for triaging an LSIL referral population [1]. As part of this study, genotype-specific distribution and attributable risk of high-risk (HR)-HPV in cervical intraepithelial neoplasia (CIN) were determined. METHODS: Archived cervical specimens in ThinPrep PreservCyt (Hologic Inc) from the LSIL referral population (n= 533) were genotyped using the Anyplex II HPV HR test (Anyplex, Seegene Inc). Since the study specimens had been in storage in ambient temperature for 31-47 months since collection, Anyplex results were compared with that of the initial cobas testing of fresh specimens to validate the suitability and stability of specimens for the present study. RESULTS: Overall, Anyplex test was positive in 63% (336/533) vs. 55.7% (297/533) for cobas test. Anyplex test performed identical to cobas test identifying 93.2% (82/88) of ⩾CIN2/adenocarcinoma in situ (AIS). Anyplex test detected genotypes 16/18 in 15.7% (36/230) ⩽CIN1 vs. 45.5% (40/88) ⩾CIN2/AIS; the corresponding figures were 13.5% (31/230) and 45.5% (40/48) for the cobas test. Genotype 16 showed increasing attribution, 13.2% in CIN1, 27.1% in CIN2 and 40% in CIN3/AIS. Of the 12 other high-risk (OHR) types collectively identified by cobas, Anyplex test specifically detected, in decreasing order, genotypes 51, 31, 35, 56, 39, and 45 as the most frequent types, often in multiple-type infections, in 64.8% ⩾CIN2. Regardless, estimated attribution was evident for each of the 12 OHR types in ⩾CIN2. Multiple-type infections were more frequent than single-type infections in all CIN grades. CONCLUSIONS: Attributable risk of all HR-HPV genotypes targeted by both Anyplex and cobas tests was evident in ⩾CIN2/AIS Testing for these genotypes in HPV primary cervical screening and cytology triage could identify those at increased risk of cervical cancer and also be beneficial in the management of LSIL referral populations.
Asunto(s)
Infecciones por Papillomavirus , Displasia del Cuello del Útero , Neoplasias del Cuello Uterino , Femenino , Humanos , Neoplasias del Cuello Uterino/patología , Infecciones por Papillomavirus/complicaciones , Infecciones por Papillomavirus/genética , Infecciones por Papillomavirus/epidemiología , Detección Precoz del Cáncer/métodos , Sensibilidad y Especificidad , Papillomaviridae/genética , GenotipoRESUMEN
OBJECTIVES & METHODS: CINtec PLUS and cobas HPV tests were compared for triaging patients referred to colposcopy with a history of LSIL cytology in a 2-year prospective study. Cervical specimens were tested once at enrollment, and test positivity rates determined. Test performance was ascertained with cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3 or worse (CIN3+) serving as clinical endpoints. RESULTS: In all ages, (19-76 years, n= 598), 44.3% tested CINtec PLUS positive vs. 55.4% HPV positive (p< 0.001). To detect CIN2+ (n= 99), CINtec PLUS was 81.8% sensitive vs. 93.9% for HPV testing (p= 0.009); genotype 16/18-specific sensitivity was 46.5%. Specificity was 52.9% vs. 36.6%, respectively (p< 0.001). In all ages, to detect CIN3+ (n= 44), sensitivity was 93.2% for both tests; genotype 16/18-specific sensitivity was 52.3%. Specificity was 48.4% for CINtec PLUS vs. 31.1% for HPV testing (p< 0.001). In patients < 30 years, CINtec was 91.7% sensitive vs 95.8% for HPV testing (p= 0.549). CONCLUSIONS: CINtec PLUS or cobas HPV test could serve as a predictor of CIN3+ with high sensitivity in patients referred to colposcopy with a history of LSIL regardless of age while significantly reducing the number of LSIL referral patients requiring further investigations and follow-up in colposcopy clinics.
Asunto(s)
Infecciones por Papillomavirus , Displasia del Cuello del Útero , Neoplasias del Cuello Uterino , Adulto , Anciano , Canadá , Colposcopía , Inhibidor p16 de la Quinasa Dependiente de Ciclina , Detección Precoz del Cáncer , Femenino , Humanos , Antígeno Ki-67 , Persona de Mediana Edad , Papillomaviridae/genética , Embarazo , Estudios Prospectivos , Derivación y Consulta , Sensibilidad y Especificidad , Neoplasias del Cuello Uterino/diagnóstico , Adulto Joven , Displasia del Cuello del Útero/genéticaRESUMEN
Research using nucleic acid amplification tests (NAATs) have repeatedly found rectal and oropharyngeal infections with Chlamydia trachomatis and Neisseria gonorrhoeae to be common and potentially more difficult to treat than genital infections. Unfortunately, public health and patient care efforts have been hampered by the lack of FDA-cleared NAATs with claims for anorectal or oropharyngeal samples. At the time of the initiation of this study, no commercially available assays had these claims. We formed a novel partnership among academic institutions and diagnostic manufacturers to address this public health need. From May 2018 through August 2019, we recruited 1108 women, 1256 men, and 26 transgender persons each of whom provided 3 anal and 3 oropharyngeal swab specimens. The 3 anal swabs were pooled into a single transport tube as were the 3 oropharyngeal swabs. The performance of each of three study assays was estimated by comparison to the composite result and relative to one another. Percent positivity for chlamydia was 5.9 and 1.2% from anal and oropharyngeal specimens, respectively, compared to 4.2 and 4.1% for gonorrhea. Sensitivity for chlamydia detection ranged from 81.0 to 95.1% and 82.8 to 100% for anal and oropharyngeal specimens, respectively. Gonorrhea sensitivity ranged from 85.9 to 99.0% and 74.0 to 100% for anal and oropharyngeal samples, respectively. Specificity estimates were ≥ 98.9% for all assays, organisms, and sample types. Although there was heterogeneity between sensitivity estimates, these assays offer better ability to detect extragenital infections than culture and potential solutions for providing appropriate sexual health care for populations in which these infections are of concern.
Asunto(s)
Infecciones por Chlamydia , Gonorrea , Infecciones por Chlamydia/diagnóstico , Chlamydia trachomatis/genética , Femenino , Gonorrea/diagnóstico , Humanos , Masculino , Neisseria gonorrhoeae/genética , Técnicas de Amplificación de Ácido Nucleico , Sensibilidad y EspecificidadRESUMEN
OBJECTIVE: To assess the concordance of high-risk HPV (HR-HPV) testing with the Alinity assay on cervical samples collected with diverse collection/storage protocols (ThinPrep, SurePath, Cervicollect) and to assess inter-assay concordance of HR-HPV testing of cervical cell specimens with Alinity m HR HPV assay (Alinity) vs cobas® 4800 HPV assay (cobas). METHODS: Specimens were obtained from 560 women attending a Women's Health clinic. Two specimens were obtained from each woman with combinations of two of the three collection devices and aliquots were tested by the two assays. RESULTS: Alinity showed an agreement of 93.9%, Kappa = 0.89 (263/280) between ThinPrep and SurePath specimens; 97.5%, Kappa = 0.95 (347/356) and 92.9%, Kappa = 0.85 (104/112) between ThinPrep and SurePath aliquots taken before or after cytology processing, respectively. Cervi-Collect specimens showed an agreement of 94.6%, Kappa = 0.89 (265/280) with ThinPrep specimens. Compared to cobas, Alinity showed agreements of 94.3%, Kappa = 0.88 (395/419) and 91.8%, Kappa = 0.82 (257/280) between ThinPrep and SurePath specimens, respectively. Alinity and cobas detected genotypes 16/18 and other high-risk HPV types at similar rates and showed similar correlations with cytology grades. CONCLUSIONS: Compared to cobas, Alinity performed equally well for detecting HPV in cervical specimens obtained with ThinPrep and SurePath. The Cervi-Collect device compared well to the other collection methods. Alinity is a reliable assay for simultaneous detection of HPV-16/18 and other high-risk genotypes in cervical specimens.
Asunto(s)
Infecciones por Papillomavirus , Neoplasias del Cuello Uterino , Femenino , Papillomavirus Humano 16 , Papillomavirus Humano 18 , Humanos , Papillomaviridae/genética , Infecciones por Papillomavirus/diagnóstico , Neoplasias del Cuello Uterino/diagnósticoRESUMEN
ABSTRACT: Aptima Mycoplasma genitalium (MG) required the shortest and STD6 the longest time to detect MG in clinical samples. ResistancePlus MG detected MG and macrolide resistance-mediating mutations simultaneously. Times were influenced by specimen numbers. M. genitalium positives from the other 2 assays required increased time for macrolide resistance-mediating mutation sequencing.
Asunto(s)
Antibacterianos , Farmacorresistencia Bacteriana , Mycoplasma genitalium , Antibacterianos/farmacología , Farmacorresistencia Bacteriana/genética , Humanos , Macrólidos/farmacología , Mutación , Infecciones por Mycoplasma/diagnóstico , Infecciones por Mycoplasma/tratamiento farmacológico , Mycoplasma genitalium/genética , Flujo de TrabajoRESUMEN
Tumor necrosis factor alpha (TNF-α) was initially recognized as a factor that causes the necrosis of tumors, but it has been recently identified to have additional important functions as a pathological component of autoimmune diseases. TNF-α binds to two different receptors, which initiate signal transduction pathways. These pathways lead to various cellular responses, including cell survival, differentiation, and proliferation. However, the inappropriate or excessive activation of TNF-α signaling is associated with chronic inflammation and can eventually lead to the development of pathological complications such as autoimmune diseases. Understanding of the TNF-α signaling mechanism has been expanded and applied for the treatment of immune diseases, which has resulted in the development of effective therapeutic tools, including TNF-α inhibitors. Currently, clinically approved TNF-α inhibitors have shown noticeable potency in a variety of autoimmune diseases, and novel TNF-α signaling inhibitors are being clinically evaluated. In this review, we briefly introduce the impact of TNF-α signaling on autoimmune diseases and its inhibitors, which are used as therapeutic agents against autoimmune diseases.
Asunto(s)
Enfermedades Autoinmunes , Factores Inmunológicos/uso terapéutico , Transducción de Señal , Factor de Necrosis Tumoral alfa , Animales , Enfermedades Autoinmunes/tratamiento farmacológico , Enfermedades Autoinmunes/inmunología , Enfermedades Autoinmunes/patología , Enfermedad Crónica , Humanos , Transducción de Señal/efectos de los fármacos , Transducción de Señal/inmunología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Factor de Necrosis Tumoral alfa/inmunologíaRESUMEN
BACKGROUND: The objective was to compare commercial assays on clinical specimens for Mycoplasma genitalium (MG) detection and macrolide resistance mutation (MRM) frequency. METHODS: Three self-collected vaginal swabs (VS) and a first-void urine (FVU) from 300 consented women were tested by Aptima MG (AMG), ResistancePlus MG (RPMG) and Seeplex STD6 ACE (STD6) for detection of MG. Aptima MG and STD6 MG positives were tested for MRM using MG 23S rRNA polymerase chain reaction with Sanger sequencing (23SMGSS) compared with MRM determination in the RPMG assay. Unique AMG positives were tested with confirmatory Aptima assays. RESULTS: M. genitalium prevalence ranged from 7.1% to 19.7%, influenced by the assay used and the specimen tested. Overall agreements for MG detection were 96.3% (κ = 0.91) for VS and 93.3% (κ = 0.72) for FVU between AMG and RPMG with lower agreements with STD6. Using a rotating reference standard, sensitivities on VS and FVU were 100% and 100% for AMG, 100% and 83.3% for RPMG, and 54.2% and 48.4% for STD6. Specificities were high for RPMG and STD6 and AMG detected extra positives, most of which were confirmed. Macrolide resistance mutation frequency rates testing VS and FVU were 50% (24/48) and 58.1% (18/31) by RPMG compared with 52.5% (31/59) and 23.5% (12/51) by 23SMGSS. MRM overall agreements between RPMG and 23SMGSS were 73.2% (κ = 0.41) for VS and 76.0% (κ = 0.52) for FVU. CONCLUSIONS: Aptima MG detected more cases of MG infections. ResistancePlus MG detection was more effective on VS than on FVU. Seeplex STD6 ACE performance was inferior. The MRM detection component of RPMG agreed with results from 23SMGSS most of the time.
Asunto(s)
Infecciones por Mycoplasma , Mycoplasma genitalium , Antibacterianos/farmacología , Farmacorresistencia Bacteriana/efectos de los fármacos , Farmacorresistencia Bacteriana/genética , Femenino , Humanos , Macrólidos/farmacología , Mutación , Infecciones por Mycoplasma/diagnóstico , Mycoplasma genitalium/efectos de los fármacos , Mycoplasma genitalium/genéticaRESUMEN
OBJECTIVE AND METHODS: CINtec PLUS and cobas HPV tests were assessed for triaging women referred to colposcopy with a history of LSIL cytology. Both tests were performed at baseline using ThinPrep cervical specimens and biopsy confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) served as the clinical endpoint. RESULTS: In all ages, (19-76 years, n = 600), 44.3% (266/600) tested CINtec PLUS positive vs. 55.2% (331/600) HPV positive (p = 0.000). Based on 224 having biopsies, sensitivity to detect CIN2+ (n = 54) was 81.5% (44/54) for CINtec PLUS vs. 94.4% (51/54) for HPV testing (p = 0.039); specificities were, 52.4% (89/170) vs. 44.1% (75/170), respectively (p = 0.129). In women ≥30 years (n = 386), 41.2% (159/386) tested CINtec PLUS positive vs. 50.8% (196/386) HPV positive (p = 0.008). Based on 135 having biopsies, sensitivity to detect CIN2+ (n = 24) was 95.8% (23/24) for both CINtec PLUS and HPV tests; specificities were, 55.0% (61/111) vs. 50.5% (56/111), respectively (p = 0.503). CONCLUSIONS: For women referred to colposcopy with a history of LSIL cytology, CINtec PLUS or cobas HPV test could serve as a predictor of CIN2+ with high sensitivity, particularly in women ≥30 years. Either test can significantly reduce the number of women requiring further investigations and follow up in colposcopy clinics.
Asunto(s)
Técnicas de Diagnóstico Molecular/normas , Papillomaviridae/genética , Infecciones por Papillomavirus/diagnóstico , Juego de Reactivos para Diagnóstico/normas , Lesiones Intraepiteliales Escamosas/diagnóstico , Adulto , Anciano , Cuello del Útero/patología , Cuello del Útero/virología , Colposcopía/estadística & datos numéricos , ADN Viral/genética , Femenino , Humanos , Persona de Mediana Edad , Técnicas de Diagnóstico Molecular/estadística & datos numéricos , Ontario , Infecciones por Papillomavirus/virología , Estudios Prospectivos , Juego de Reactivos para Diagnóstico/estadística & datos numéricos , Sensibilidad y Especificidad , Lesiones Intraepiteliales Escamosas/patología , Lesiones Intraepiteliales Escamosas/virología , Neoplasias del Cuello Uterino/virología , Adulto Joven , Displasia del Cuello del Útero/diagnóstico , Displasia del Cuello del Útero/virologíaRESUMEN
Early determination of high-risk human papillomaviruses causing oropharyngeal squamous cell carcinomas (OPSCC) may influence treatment. The objectives were to evaluate the performance of a new rapid isothermal nucleic acid amplification point of care HPV test (AmpFire HPV) on fine needle neck aspirates (FNA) of cervical lymph nodes and oropharyngeal swabs and saliva (OPS) which had been previously tested by the cobas HPV assay. The comparison was performed on 56 FNA and 81 OPS. The two assays showed strong agreement (94.6 %, Kâ¯=â¯0.88) on FNA and fair agreement (65.4 %, Kâ¯=â¯0.34) on OPS. AmpFire HPV performed on FNA demonstrated a sensitivity of 76.7 % and specificity of 81.8 % for the prediction of p16 antigens in OPSCC with results available in 1.5â¯h.
Asunto(s)
Ganglios Linfáticos/virología , Neoplasias Orofaríngeas/diagnóstico , Infecciones por Papillomavirus/complicaciones , Infecciones por Papillomavirus/diagnóstico , Carcinoma de Células Escamosas de Cabeza y Cuello/diagnóstico , Biopsia con Aguja Fina , ADN Viral/genética , Humanos , Técnicas de Amplificación de Ácido Nucleico , Neoplasias Orofaríngeas/virología , Saliva/virología , Sensibilidad y Especificidad , Carcinoma de Células Escamosas de Cabeza y Cuello/virologíaRESUMEN
Self-obtained vaginal swabs, first-void urine and pooled specimens were collected at home and in a clinic. Percent prevalence and collection site concordance was 30.3 and 100 for Mycoplasma genitalium (74.4% azithromycin resistant) 15.1 and 96.7 for Chlamydia trachomatis and 6.6 and 100 for Neisseria gonorrhoeae (27% ciprofloxacin-resistant).
Asunto(s)
Infecciones por Chlamydia/diagnóstico , Chlamydia trachomatis/genética , Gonorrea/diagnóstico , Infecciones por Mycoplasma/diagnóstico , Mycoplasma genitalium/genética , Neisseria gonorrhoeae/genética , Vagina/microbiología , Adolescente , Adulto , Instituciones de Atención Ambulatoria/estadística & datos numéricos , Infecciones por Chlamydia/orina , Femenino , Gonorrea/orina , Humanos , Infecciones por Mycoplasma/orina , Técnicas de Amplificación de Ácido Nucleico , Manejo de Especímenes/métodos , Adulto JovenRESUMEN
Because of its non-invasive nature urine testing may enable increased screening for HPV in women who avoid cervical sampling. Comparisons have shown fewer HPV positives in urine. The objectives were to compare first-void urine (FVU) treated with proteinase K (PK) to untreated FVU and cervical samples collected from women attending a colposcopy clinic using an Aptima HPV mRNA assay, and comparing the HPV rates to cytology and pathology results. Female FVU (n = 433) was treated with Aptima Transfer Solution (ATS) containing PK within 24 h or after months of storage. Untreated female FVU samples were HPV-positive in 20.8-27.6% compared to 34.4-45.6% of ATS-treated FVU and 44.9-48.4% of PreservCyt samples. Good overall agreement for HR-HPV detection between ATS-FVU and PreservCyt was observed (81.1%; k 0.63). Validation of ATS treatment was performed on 356 male FVU, detecting 6.7% HPV positive compared to 3.4% of untreated samples (p = 0.059). Although HPV presence in ATS FVU and PreservCyt samples were similar, significantly more women with abnormal cervical cytology and histopathology were HPV-positive in cervical specimens than in ATS-treated FVU.
Asunto(s)
Detección Precoz del Cáncer/métodos , Proteínas Oncogénicas Virales/genética , Infecciones por Papillomavirus/orina , ARN Viral/aislamiento & purificación , Manejo de Especímenes/métodos , Orina/química , Adulto , Anciano , Cuello del Útero/virología , Estudios Transversales , Endopeptidasa K/química , Femenino , Técnicas Histológicas , Humanos , Masculino , Persona de Mediana Edad , Infecciones por Papillomavirus/diagnóstico , Infecciones por Papillomavirus/virología , Preservación Biológica , Sensibilidad y Especificidad , Neoplasias del Cuello Uterino/diagnóstico , Neoplasias del Cuello Uterino/virología , Adulto Joven , Displasia del Cuello del Útero/diagnóstico , Displasia del Cuello del Útero/virologíaRESUMEN
BACKGROUND: HPV FOCAL is a randomized trial comparing high-risk HPV [Hybrid Capture 2 (HC2)] vs. liquid-based cytology (LBC) for primary cervical screening. OBJECTIVE: The present study objective was to compare Aptima HPV (AHPV) and HC2 assay performance at the intervention arm baseline and 48 mo. screens in relation to the rates of cervical intraepithelial neoplasia (CIN) grade 2 or worse (CIN2+). STUDY DESIGN: Women enrolled after December 2010 (n = 3475) were screened at baseline with both AHPV and HC2 (AHPV was blinded). Women with CIN2+ exited the trial; HC2 negative (-) women and those HC2 positive (+) with Asunto(s)
Técnicas de Laboratorio Clínico/métodos
, ADN Viral/aislamiento & purificación
, Detección Precoz del Cáncer/métodos
, Papillomaviridae/aislamiento & purificación
, ARN Mensajero/aislamiento & purificación
, Femenino
, Humanos
, ARN Viral/aislamiento & purificación
, Displasia del Cuello del Útero/diagnóstico
, Neoplasias del Cuello Uterino/diagnóstico
, Neoplasias del Cuello Uterino/virología
RESUMEN
SurePath specimens from women referred to colposcopy were treated with Aptima Transfer Solution (ATS) before testing in Aptima HPV (AHPV) and Aptima HPV 16, 18/45 (AHPV-GT) assays. Untreated SurePath specimens were tested with the cobas HPV test. PreservCyt specimens were assessed for cytology and tested with AHPV. High-grade cervical intraepithelial neoplasia lesions served as the reference standard. Excellent agreement (95.5%; k=0.91) was observed for ATS-treated SurePath specimens between Tigris and Panther systems and between the PreservCyt and ATS-treated SurePath specimens (91.1%, k=0.81) with the AHPV assay on Tigris. Agreement between the AHPV and cobas assays with SurePath specimens was substantial (89.9%, k=0.80). AHPV sensitivity for CIN2+(n=147) was 91.2% for SurePath and PreservCyt. Cobas HPV sensitivity was 93.9% for SurePath specimens. AHPV testing of SurePath specimens was more specific (59.4%) than cobas (54.7%) (p<0.001). Detection and genotyping showed similar absolute and relative risks. ATS-treated SurePath specimens tested with AHPV and AHPV-GT assays showed similar performance with greater specificity than cobas HPV on SurePath specimens. Similar overall results were seen using a CIN3 disease endpoint.
RESUMEN
Urinary meatal swabs compared with urine showed higher infection rates for Mycoplasma genitalium (15.3% vs 12.6%, P = 0.035), Chlamydia trachomatis (11.3% vs 9.3%, P = 0.039), Neisseria gonorrhoeae (1.4% vs 1.1%, P = 1.00), Trichomonas vaginalis (8.0% vs 1.7%, P < 0.001), and high-risk human papillomavirus (5.9% vs 3.4%, P = 0.078) respectively.
Asunto(s)
Infecciones por Chlamydia/diagnóstico , Gonorrea/diagnóstico , Infecciones por Mycoplasma/diagnóstico , Infecciones por Papillomavirus/diagnóstico , Enfermedades de Transmisión Sexual/diagnóstico , Vaginitis por Trichomonas/diagnóstico , Adolescente , Infecciones por Chlamydia/microbiología , Chlamydia trachomatis/aislamiento & purificación , Femenino , Gonorrea/microbiología , Humanos , Masculino , Infecciones por Mycoplasma/microbiología , Mycoplasma genitalium/aislamiento & purificación , Neisseria gonorrhoeae/aislamiento & purificación , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/virología , Autoadministración , Enfermedades de Transmisión Sexual/microbiología , Enfermedades de Transmisión Sexual/parasitología , Manejo de Especímenes , Vaginitis por Trichomonas/parasitología , Trichomonas vaginalis/aislamiento & purificación , Uretra/microbiología , Uretra/parasitología , Orina/microbiología , Orina/parasitología , Adulto JovenRESUMEN
Testing remnant Aptima specimens from women infected with Chlamydia trachomatis detected 13.4% (53/396) with Mycoplasma genitalium compared with 5.4% (22/406) in matched C. trachomatis-negative women. Overall, 9.4% (provincial ranges of 3-20%) were infected with M. genitalium and resistance mediating mutations were found in 47.3% (26/55) to macrolides and 1.9% (1/53) to fluoroquinolones by sequencing.
Asunto(s)
Infecciones por Chlamydia/epidemiología , Infecciones por Chlamydia/microbiología , Farmacorresistencia Bacteriana/efectos de los fármacos , Farmacorresistencia Bacteriana/genética , Infecciones por Mycoplasma/epidemiología , Infecciones por Mycoplasma/microbiología , Mycoplasma genitalium/efectos de los fármacos , Mycoplasma genitalium/genética , Adolescente , Adulto , Antibacterianos/farmacología , Canadá/epidemiología , Chlamydia trachomatis , Coinfección , Femenino , Fluoroquinolonas/farmacología , Humanos , Macrólidos/farmacología , Persona de Mediana Edad , Tipificación de Secuencias Multilocus , Mutación , Infecciones por Mycoplasma/tratamiento farmacológico , Polimorfismo de Nucleótido Simple , Prevalencia , Adulto JovenRESUMEN
BACKGROUND: Human papilloma virus (HPV) has been implicated in the development of a large proportion of oropharyngeal squamous cell carcinoma (OPSCC). Current techniques used to diagnose HPV etiology require histopathologic analysis. We aim to investigate the diagnostic accuracy of a new application non-histopathologic diagnostic tests to help assist diagnosis of HPV-related oropharyngeal tumors. METHODS: Patients with OPSCC with nodal metastasis were consecutively recruited from a multidisciplinary cancer clinic. Appropriate samples were collected and analyzed. The various tests examined included COBAS® 4800, Cervista® HR and Genotyping. These tests were compared to p16 staining, which was used as the diagnostic standard. StataIC 14.2 was used to perform analysis, including sensitivity, specificity and receiver operator characteristic [ROC] curves. RESULTS: The COBAS® FNA (area under ROC 0.863) and saliva (area under ROC 0.847) samples performed well in diagnosing HPV positive and negative tumors. Samples tested with Cervista® did not corroborate p16 status reliably. We were able to increase the diagnostic yield of the COBAS® FNA samples by applying the results of the saliva test to negative FNA samples which correctly identified 11 additional p16 positive tumors (area under ROC 0.915). CONCLUSION: Surrogate testing for HPV using alternate methods is feasible and closely predicts the results of standard diagnostic methods. In the future, these could minimize invasive procedures for diagnosing HPV-related oropharyngeal cancer, but also help to diagnose and treat patients with unknown primaries.
Asunto(s)
Carcinoma de Células Escamosas/virología , Neoplasias de Cabeza y Cuello/virología , Neoplasias Orofaríngeas/virología , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Algoritmos , Biopsia con Aguja Fina , Carcinoma de Células Escamosas/patología , Estudios de Cohortes , ADN Viral/análisis , Femenino , Neoplasias de Cabeza y Cuello/patología , Humanos , Inmunohistoquímica , Masculino , Persona de Mediana Edad , Ontario , Neoplasias Orofaríngeas/patología , Pronóstico , Curva ROC , Estudios Retrospectivos , Medición de Riesgo , Carcinoma de Células Escamosas de Cabeza y CuelloRESUMEN
OBJECTIVES: North American and European advisory groups recommend testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) with nucleic acid amplification tests. Testing is often performed on automated instruments. The objectives of this study were to process urines for the diagnosis of CT and NG and to examine workflow procedures and outcomes. METHODS: While processing 1, 24, 48, 96, and 192 urine specimens on 3 batch-mode systems which use 96-well plates: cobas 4800, m2000, and Viper XTR and the random access cartridge testing GeneXpert Infinity 80, we measured assay performance, hands-on time for processing and maintenance, reagents and plastics consumption, time required to obtain results, and testing accuracy. RESULTS: The Infinity 80 required the least hands-on time for single specimens and smaller batches, whereas the Viper XTR and m2000 required the most hands-on time for all batch sizes. Cumulative daily, weekly, and monthly maintenance was highest for the Viper XTR and lowest for Infinity 80. All batch-mode instruments consumed large amounts of disposables. Time to results was shortest for the Infinity 80, and the Viper XTR provided the shortest time for the batch-mode instruments. All systems showed similar diagnostic accuracy. CONCLUSIONS: Because detection performances were similar, issues of hands-on time, maintenance, time to results, and consumables are important operational factors for the diagnosis and treatment of CT/NG infections.
Asunto(s)
Infecciones por Chlamydia/diagnóstico , Gonorrea/diagnóstico , Técnicas de Amplificación de Ácido Nucleico/instrumentación , Evaluación de Procesos y Resultados en Atención de Salud , Manejo de Especímenes/instrumentación , Urinálisis/instrumentación , Infecciones por Chlamydia/microbiología , Chlamydia trachomatis , Gonorrea/microbiología , Humanos , Neisseria gonorrhoeae , Técnicas de Amplificación de Ácido Nucleico/métodos , Sensibilidad y Especificidad , Manejo de Especímenes/métodos , Urinálisis/métodosRESUMEN
BACKGROUND: Cervical cancer screening programs are switching from Pap screening to high-risk HPV testing. OBJECTIVES: To compare the Aptima HPV Assay (AHPV) with the Hybrid Capture® 2 High-Risk HPV DNA Test® (HC2) for primary cervical screening. STUDY DESIGN: HPV FOCAL is a randomized trial comparing HC2 to liquid-based cytology (LBC) for screening women aged 25-65. AHPV and HC2 were compared at the baseline screen (n=3473). Genotyping was by the Aptima HPV 16 18/45 Genotype Assay. We assessed HPV genotyping and reflex LBC for colposcopy triage. RESULTS: AHPV/HC2 agreement was 96.5% (kappa 0.76); positive agreement was 77.4%. The AHPV positive rate was 7.2% vs. 8.4% for HC2 (p=0.06). Based on HC2 screening, round 1 CIN2 and CIN3+ rates were 9.2/1000 and 5.2/1000 respectively. Using HC2 as the comparator test, AHPV CIN2+ and CIN3+ relative sensitivities were 0.96 and 1.00 (p=1.00) respectively. High-grade reflex LBC and HPV 16 infection were significantly associated with CIN3+. AHPV specificity was 0.94 vs. 0.93 (p=0.05) for HC2. Compared with triage of HC2+ with abnormal cytology or HPV persistence for 12 months, colposcopy referral would be significantly reduced (38.3/1000 vs. 60.8/1000; p<0.001) if AHPV+ women with abnormal LBC and HPV 16/18/45 were referred at baseline. CIN2+ and CIN3+ detection rates were not significantly different for the two strategies. CONCLUSIONS: AHPV vs. HC2 screening had equivalent CIN2+ and CIN3+ detection. Triage of AHPV+ by abnormal reflex LBC and the presence of HPV 16/18/45 would result in a significantly lower colposcopy referral rate with similar CIN2+ and CIN3+ detection rates as the overall HC2+ referral algorithm.
Asunto(s)
Detección Precoz del Cáncer/métodos , Técnicas de Diagnóstico Molecular/métodos , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/complicaciones , Neoplasias del Cuello Uterino/diagnóstico , Adulto , Anciano , Femenino , Humanos , Persona de Mediana Edad , Papillomaviridae/clasificación , Papillomaviridae/genética , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: The AmpliVue Trichomonas Assay (Quidel) is a new Federal Drug Administration-cleared rapid test for qualitative detection of Trichomonas vaginalis (TV) DNA in female vaginal specimens. The assay is based on BioHelix's helicase-dependent amplification isothermal technology in conjunction with a disposable lateral-flow detection device, with a total turnaround time of approximately 45 minutes. OBJECTIVE: The objective of this study was to compare the performance of this new assay to wet preparation and culture as well as to another Federal Drug Administration-cleared nucleic acid amplification assay. METHODS: Four clinician collected vaginal swabs were obtained from women attending sexually transmitted disease, family planning, and OB/GYN clinics and tested by AmpliVue Trichomonas Assay and comparator tests: saline microscopy, TV culture (InPouch), and Aptima TV. AmpliVue Trichomonas Assay results were compared with a composite positive comparator (CPC) as determined by the results from culture and/or wet mount microscopic examination. At least one of either the wet preparation or culture reference test results was required to be positive to establish CPC. RESULTS: A total of 992 patients, 342 symptomatic and 650 asymptomatic patients, were included in the study. Results for AmpliVue for all women combined compared with saline microscopy and culture as a CPC yielded a sensitivity of 100%. Specificity for all women was 98.2%. Overall percent agreement versus Aptima TV was 97.8%. Sensitivity for AmpliVue compared with Aptima was 90.7% %, whereas specificity was 98.9%. CONCLUSIONS: The rapid AmpliVue Trichomonas Assay performed as well as microscopy and culture, and had comparable sensitivity and specificity to another nucleic acid amplification test for the detection of TV. This study provided evidence of new diagnostic options and indicated very good performance of amplified testing for detection of TV in symptomatic and asymptomatic women.