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Hepatitis B virus vaccination status of medical laboratory workers; a multicentre evaluation in Turkey
Abstracts / Journal of Clinical Virology 82S (2016) S1–S142
Abstract no: 93 Presentation at ESCV 2016: Poster 129 Detection of Q80K mutation in HCV NS3 protease gene in Hradec Kralove – Initial experience Lenka Pliskova 1,∗ , Radka Kutova 2 , Stanislav Plisek 3 , Vlasta Stepanova 4 1 Inst. Clin. Biochemistry and Diagnostics – Department Mol. Biol., University Hospital and Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic 2 Clin. Biochemistry and Diagnostics – Department Mol. Biol. University Hospital and Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic 3 Clinic of Infectious Diseases, University Hospital and Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic 4 Inst. Clin. Microbiology – Virology Department, University Hospital and Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic
Background: Combination of HCV high speed replication, low accuracy and poor HCV polymerase correction result in formation of highly variable viruses overall called “quasispecies” with a high sequential diversity within different genotypes and subtypes. The impact of mentioned situation is the accumulation of virus variants with mutations (originated in aminoacids substitution) with the different grade of resistance to DAA (directly acting antivirals) in naive patients, so called RAV (resistance associated amino acid variants) [1,2]. Polymorphism Q80K in NS3 region belonging also to RAV occurs most often in patients infected with HCV 1a genotype and is associated with a decreased response to simeprevir therapy. Q80K prevalence in these patients varies in different geographical conditions. The study of Q80K prevalence in European population presents the prevalence of 19.8% in patients with genotype 1a and 0.5% in genotype 1b % [4]. At present the patients infected with HCV genotype 1a are examined for the presence of mutation in Q80K codon prior to simeprevir therapy introduction. Further clinically significant mutations described in codons 36, 43, 122, 138, 155, 156, 158, 168 are reported only in 1–2% of cases [1,3,5]. Materials and methods: Our laboratory of molecular biology introduced the detection of mutations in the gene for protease NS3 in 2015 by means of sequence analysis. The primers design was performed using Custom Primers – OligoPerfectTM Designer software. The method was optimized for HCV genotype 1a. Results: In the period of September 2015 to May 2016 the total of 45 patients were examined, in 10 of them (22%) Q80K mutation was detected.
Reference [1] M. Ogishi, H. Yotsuyanagi, T. Tsutsumi, et al., Deconvoluting the composition of low-frequency hepatitis c viral quasispecies: comparison of genotypes and NS3 resistance-associated variants between HCV/HIV coinfected hemophiliacs and HCV monoinfected patients in Japan, PLOS ONE 10 (2015) 1–28. [2] S. Paolucci, L. Fiorina, B. Mariani, et al., Naturally occurring resistance mutations to inhibitors of HCV NS5A region and NS5B polymerase in DAA treatment-naïve patients, Virol. J. 10 (2013) 355–361. [3] M. Leggewie, V.B. Greenu, T. Abdelrahman, et al., Natural NS3 resistance polymorphisms occur frequently prior to treatment in HIV-positive patients with acute hepatitis C, AIDS 27 (2013) 2485–2488. [4] C. Sarrazin, E. Lathouwers, M. Peeters, et al., Prevalence of the hepatitis C virus NS3 polymorphism Q80K in genotype 1 patients in the European region, Antivir. Res. 116 (2015) 10–16.
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[5] A. Bae, S.C. Sun, X. Qi, et al., Susceptibility of treatment-naive hepatitis C virus (HCV) clinical isolates to HCV protease inhibitors, Antimicrob. Agents Chemother. 54 (2010) 5288–5297.
http://dx.doi.org/10.1016/j.jcv.2016.08.169 Abstract no: 99 Presentation at ESCV 2016: Poster 130 Hepatitis B virus vaccination status of medical laboratory workers; a multicentre evaluation in Turkey O. Aydemir 1 , M. Koroglu 2 , B. Yuksel 2 , T. Demiray 1 , A. Ozbek 2 , S. Altindis 3 , F.G. Aslan 4 , M. Altindis 4 , LABBIOSAFETYGROUPTR5∗ 1
Sakarya Research and Training Hospital Microbiology Lab, Sakarya, Turkey 2 Sakarya University Faculty of Medicine Dept of Clin. Microbiology, Sakarya, Turkey 3 Sakarya University Faculty of Management, Health Administration, Sakarya, Turkey 4 Sakarya University Faculty of Medicine Dept of Clin. Virology and Microbiology, Sakarya, Turkey 5 Keramettin Yanik (On Dokuz Mayıs University Faculty of Medicine, Department of Medical Microbiology, Samsun), Sebahat Aksaray (Haydarpas¸a Research and Education Hospital, Microbiology Laboratory, I˙ stanbul), Nevzat Unal, Turkey Introduction and aim: The frequency of hepatitis B infection among health care workers is reported to be 3–8 times more than the normal population, particularly among workers in emergency service, surgery, intensive care unit and laboratory, who are frequently exposed to the contaminated patient materials such as blood and other body fluids [1]. In this multicentre study, we aimed to determine the rates of hepatitis B vaccination in medical laboratory workers in Turkey and aimed evaluate the precautions to be taken on this special subject. Materials and methods: Total number of 1359 medical laboratory workers from 28 medical centres representative of different regions of Turkey was included in this study. A questionnaire was designed to gather all the data on the subject planned to apply all the medical laboratory workers. Results: Total number of 1359 laboratory worker was included in this study, and male to female ratio was 0.74 (578/781). Doctors (n = 133), research assistants (n = 78), laboratory technicians (n = 196), biologists (n = 750), students (n = 24), cleaning staff and other workers (n = 161) were included in the study. We determined that HBV vaccine was applied to the 1118 laboratory workers (82.3%) out of 1359. When anti-HBs titre levels of the vaccinated participants were investigated, 715 (54.5%) of the vaccinated participants stated that they had anti-HBS levels above 10 IU/mL, 116 (8.5%) of them told that their antibody levels were below 10 IU/mL and 502 (36.9%) of them stated that they did not know their antiHBS titre levels. The results of statistical analysis revealed that vaccination rates and occupation groups were correlated among the laboratory staff (p < 0.05). However, there was no significant difference between age groups and the duration in work with the vaccination rate (p > 0.05). Anti HBs positivity was not correlated with any of the groups (p > 0.05). Discussion and conclusion: Health care professionals are required to make immunization a professional habit to protect themselves from health care associated infections in addition to implantation of standard infection control procedures [2]. Present
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Abstracts / Journal of Clinical Virology 82S (2016) S1–S142
study is the first multicentre study to reflect the HBV vaccination rates among laboratory workers across the entire country. According to the findings obtained from this study, it was understood that approximately one third of the laboratory staff was vulnerable to hepatitis B virus infections, which were protectable. As a result, medical laboratory personnel possess the risk of acquiring hepatitis B infection, so that formation of awareness is necessary by way of education. They should be tested and all staff seronegative staff should be vaccinated. Periodic monitoring for anti-HBs levels is also essential. This assessment is a necessity within the scope of ´ infection control measures, workershealth and safety [3]. Keywords: Hepatitis B virus, Surveys and questionnaires, Laboratory personnel, Vaccination Reference [1] World Health Organization. Health Care Worker Safety. AIDE-MEMOIRE for a Strategy to Protect Health Workers from Infection with Bloodborne Viruses. [2] http://www.who.int/injection safety/toolbox/en/AM HCW Safety EN. pdf?ua=1/02/02/2015. [3] Z. Karacaer, I.I. Ozturk, H. Cicek, S. Simsek, G. Duran, L. Gorenek, The level of information about the immunization of health care workers, attitudes and behaviors (Saglık c¸alıs¸anlarının ba˘gıs¸ıklanma ile ilgili bilgi düzeyleri, tutum ve davranıs¸ları), TAF Prev. Med. Bull. 14 (5) (2015).
http://dx.doi.org/10.1016/j.jcv.2016.08.170 Abstract no: 110 Presentation at ESCV 2016: Poster 131 Treatment of HIV and acute myeloid leukemia by allogeneic CCR5-d32 blood stem cell transplantation E. Knops 1,∗ , G. Kobbe 2 , R. Kaiser 1 , N. Luebke 2 , G. Dunay 3 , J. Fischer 2 , F. Huettig 2 , A. Wensing 4 , R. Haas 2 , M. Nijhuis 4 , J. Martinez-Picado 5 , D. Haeussinger 2 , B. Jensen 2 1
University of Cologne, Germany University of Duesseldorf, Germany 3 Leibniz Institute for Experimental Virology, Hamburg, Germany 4 Medical Center Utrecht, Netherlands 5 AIDS Research Institute irsiCaixa, Barcelona, Spain 2
The Berlin patient is presumed to be the only person cured from HIV-infection by hematopoietic stem cell transplantation (HSCT) from a homozygous CCR5-d32 donor. Attempts to reproduce cure by HSCT have failed because of either viral rebound or death due to the underlying malignancy. We here report a patient alive, well and negative for proviral DNA 900 days after HSCT. A 41 year old HIV-infected male patient was diagnosed acute myeloid leukemia (AML, inv16, CBF-MYH11) in 01/2011. Since the diagnosis of HIV-infection in 10/2010 he had been treated with TDF/FTC+ DRV (01/2011 VL 44 cop/mL; CD4+ 474 cells/l). To avoid interactions with chemotherapy DRV was switched to RAL in 03/2011. He achieved CR of the AML after 1 induction course (ICE) and received a 2nd induction and 3 consolidation courses according to AML-SG 07/04. In 09/2012 AML relapsed and he was treated with A-HAM and a 2nd cycle high-dose cytarabine. While in 2nd CR he received unmodified peripheral blood stem cells from a female 10/10 CCR5-d32 DKMS-donor after conditioning with fludarabine/treosulfan in 02/2013. Before transplant HIV resistance analysis was performed and viral tropism was determined. There were no significant resistance mutations and the coreceptor-usage was predicted as R5-tropic (Sanger sequencing: FPR 44.5%; NGS: 0.14% X4 at 3.5% FPR; geno2pheno). The proviral DNA load was 29400 cop/mL and in the western blot all anticipated bands could
be detected. During transplant and until today the patient remained on ART (since 06/2014 ABC/3TC/DTG) and the viral load remained undetectable in plasma and liquor. He had a 2nd relapse of AML in 06/2013 but re-entered molecular remission after a total of 8 courses of 5-azacytidine and 4 donor lymphocyte infusions. Concerning HIV, all collected samples were negative for proviral DNA by conventional and digital droplet PCR* in two different labs, namely PBMCs (06/2014, 01/2015* and 02/2015), rectal biopsy (04/2015) and bone marrow (08/2015*). Western blots from 06/2014 and 02/2015 showed incomplete patterns with fading bands. Like in the Berlin patient, all tests from the Duesseldorf patient so far suggest that HIV may have been eradicated and that he may be the second individual cured from HIV by allogeneic CCR5-d32 HSCT. Further investigations will be performed before considering the discontinuation of ART. http://dx.doi.org/10.1016/j.jcv.2016.08.171 Abstract no: 119 Presentation at ESCV 2016: Poster 132 Evaluation of the Aptima HIV-1 Quant Dx Assay using plasma and dried blood spots M. Sahoo ∗ , V. Varghese, E. White, Meg Winslow, D. Katzenstein, R. Shafer, B. Pinsky Stanford University School of Medicine, Stanford, CA, USA HIV-1 RNA quantitation in plasma, or virus load testing, is the primary method by which the response to antiretroviral therapy is monitored. In the current study, we describe the analytical and clinical evaluation of the Aptima® HIV-1 Quant Dx assay (Aptima) performed on the automated Panther® system. Using HIV-1 subtype B, Aptima had a dynamic range extending from 6.7 to 2.0 log10 copies/mL, the lower limit of 95% detection was <20 copies/mL, and within-laboratory precision at low virus loads ranged from percent coefficient of variation (CV) of 8.13% at 1.7 log10 copies/mL to 3.59% at 3.0 log10 copies/mL. The clinical performance of Aptima was compared to the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test v2.0 (CAP/CTM) using 162 EDTA plasma samples collected from patients undergoing HIV-1 monitoring. Overall agreement was 84.0% (136/162) with a kappa statistic of 0.723 (Standard Error 0.047; 95% CI 0.630–0.815) indicating substantial agreement. Using the 86 clinical samples quantifiable by both methods, Passing-Bablok regression revealed a regression line of Y = 1.069X − 0.346 [95% CI of the slope (1.003–1.139) and intercept (−0.666 to −0.074)] and Bland–Altman analysis demonstrated a mean difference (Aptima-CAP/CTM) of −0.075 log10 copies/mL (95% limits of agreement of −0.624 to 0.475), consistent with negative bias. Comparison of Aptima testing on paired dried blood spot (DBS) and plasma specimens archived from participants in the Peninsula AIDS Research Cohort Study (PARC) demonstrated an overall agreement of 94.7% (90/95) when 1000 copies/mL was used as threshold. In conclusion, the Aptima HIV-1 Quant Dx assay provides a suitable alternative for HIV-1 monitoring in plasma and DBS. http://dx.doi.org/10.1016/j.jcv.2016.08.172
Abstract no: 93 Presentation at ESCV 2016: Poster 129 Detection of Q80K mutation in HCV NS3 protease gene in Hradec Kralove – Initial experience Lenka Pliskova 1,∗ , Radka Kutova 2 , Stanislav Plisek 3 , Vlasta Stepanova 4 1 Inst. Clin. Biochemistry and Diagnostics – Department Mol. Biol., University Hospital and Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic 2 Clin. Biochemistry and Diagnostics – Department Mol. Biol. University Hospital and Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic 3 Clinic of Infectious Diseases, University Hospital and Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic 4 Inst. Clin. Microbiology – Virology Department, University Hospital and Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic
Background: Combination of HCV high speed replication, low accuracy and poor HCV polymerase correction result in formation of highly variable viruses overall called “quasispecies” with a high sequential diversity within different genotypes and subtypes. The impact of mentioned situation is the accumulation of virus variants with mutations (originated in aminoacids substitution) with the different grade of resistance to DAA (directly acting antivirals) in naive patients, so called RAV (resistance associated amino acid variants) [1,2]. Polymorphism Q80K in NS3 region belonging also to RAV occurs most often in patients infected with HCV 1a genotype and is associated with a decreased response to simeprevir therapy. Q80K prevalence in these patients varies in different geographical conditions. The study of Q80K prevalence in European population presents the prevalence of 19.8% in patients with genotype 1a and 0.5% in genotype 1b % [4]. At present the patients infected with HCV genotype 1a are examined for the presence of mutation in Q80K codon prior to simeprevir therapy introduction. Further clinically significant mutations described in codons 36, 43, 122, 138, 155, 156, 158, 168 are reported only in 1–2% of cases [1,3,5]. Materials and methods: Our laboratory of molecular biology introduced the detection of mutations in the gene for protease NS3 in 2015 by means of sequence analysis. The primers design was performed using Custom Primers – OligoPerfectTM Designer software. The method was optimized for HCV genotype 1a. Results: In the period of September 2015 to May 2016 the total of 45 patients were examined, in 10 of them (22%) Q80K mutation was detected.
Reference [1] M. Ogishi, H. Yotsuyanagi, T. Tsutsumi, et al., Deconvoluting the composition of low-frequency hepatitis c viral quasispecies: comparison of genotypes and NS3 resistance-associated variants between HCV/HIV coinfected hemophiliacs and HCV monoinfected patients in Japan, PLOS ONE 10 (2015) 1–28. [2] S. Paolucci, L. Fiorina, B. Mariani, et al., Naturally occurring resistance mutations to inhibitors of HCV NS5A region and NS5B polymerase in DAA treatment-naïve patients, Virol. J. 10 (2013) 355–361. [3] M. Leggewie, V.B. Greenu, T. Abdelrahman, et al., Natural NS3 resistance polymorphisms occur frequently prior to treatment in HIV-positive patients with acute hepatitis C, AIDS 27 (2013) 2485–2488. [4] C. Sarrazin, E. Lathouwers, M. Peeters, et al., Prevalence of the hepatitis C virus NS3 polymorphism Q80K in genotype 1 patients in the European region, Antivir. Res. 116 (2015) 10–16.
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[5] A. Bae, S.C. Sun, X. Qi, et al., Susceptibility of treatment-naive hepatitis C virus (HCV) clinical isolates to HCV protease inhibitors, Antimicrob. Agents Chemother. 54 (2010) 5288–5297.
http://dx.doi.org/10.1016/j.jcv.2016.08.169 Abstract no: 99 Presentation at ESCV 2016: Poster 130 Hepatitis B virus vaccination status of medical laboratory workers; a multicentre evaluation in Turkey O. Aydemir 1 , M. Koroglu 2 , B. Yuksel 2 , T. Demiray 1 , A. Ozbek 2 , S. Altindis 3 , F.G. Aslan 4 , M. Altindis 4 , LABBIOSAFETYGROUPTR5∗ 1
Sakarya Research and Training Hospital Microbiology Lab, Sakarya, Turkey 2 Sakarya University Faculty of Medicine Dept of Clin. Microbiology, Sakarya, Turkey 3 Sakarya University Faculty of Management, Health Administration, Sakarya, Turkey 4 Sakarya University Faculty of Medicine Dept of Clin. Virology and Microbiology, Sakarya, Turkey 5 Keramettin Yanik (On Dokuz Mayıs University Faculty of Medicine, Department of Medical Microbiology, Samsun), Sebahat Aksaray (Haydarpas¸a Research and Education Hospital, Microbiology Laboratory, I˙ stanbul), Nevzat Unal, Turkey Introduction and aim: The frequency of hepatitis B infection among health care workers is reported to be 3–8 times more than the normal population, particularly among workers in emergency service, surgery, intensive care unit and laboratory, who are frequently exposed to the contaminated patient materials such as blood and other body fluids [1]. In this multicentre study, we aimed to determine the rates of hepatitis B vaccination in medical laboratory workers in Turkey and aimed evaluate the precautions to be taken on this special subject. Materials and methods: Total number of 1359 medical laboratory workers from 28 medical centres representative of different regions of Turkey was included in this study. A questionnaire was designed to gather all the data on the subject planned to apply all the medical laboratory workers. Results: Total number of 1359 laboratory worker was included in this study, and male to female ratio was 0.74 (578/781). Doctors (n = 133), research assistants (n = 78), laboratory technicians (n = 196), biologists (n = 750), students (n = 24), cleaning staff and other workers (n = 161) were included in the study. We determined that HBV vaccine was applied to the 1118 laboratory workers (82.3%) out of 1359. When anti-HBs titre levels of the vaccinated participants were investigated, 715 (54.5%) of the vaccinated participants stated that they had anti-HBS levels above 10 IU/mL, 116 (8.5%) of them told that their antibody levels were below 10 IU/mL and 502 (36.9%) of them stated that they did not know their antiHBS titre levels. The results of statistical analysis revealed that vaccination rates and occupation groups were correlated among the laboratory staff (p < 0.05). However, there was no significant difference between age groups and the duration in work with the vaccination rate (p > 0.05). Anti HBs positivity was not correlated with any of the groups (p > 0.05). Discussion and conclusion: Health care professionals are required to make immunization a professional habit to protect themselves from health care associated infections in addition to implantation of standard infection control procedures [2]. Present
S86
Abstracts / Journal of Clinical Virology 82S (2016) S1–S142
study is the first multicentre study to reflect the HBV vaccination rates among laboratory workers across the entire country. According to the findings obtained from this study, it was understood that approximately one third of the laboratory staff was vulnerable to hepatitis B virus infections, which were protectable. As a result, medical laboratory personnel possess the risk of acquiring hepatitis B infection, so that formation of awareness is necessary by way of education. They should be tested and all staff seronegative staff should be vaccinated. Periodic monitoring for anti-HBs levels is also essential. This assessment is a necessity within the scope of ´ infection control measures, workershealth and safety [3]. Keywords: Hepatitis B virus, Surveys and questionnaires, Laboratory personnel, Vaccination Reference [1] World Health Organization. Health Care Worker Safety. AIDE-MEMOIRE for a Strategy to Protect Health Workers from Infection with Bloodborne Viruses. [2] http://www.who.int/injection safety/toolbox/en/AM HCW Safety EN. pdf?ua=1/02/02/2015. [3] Z. Karacaer, I.I. Ozturk, H. Cicek, S. Simsek, G. Duran, L. Gorenek, The level of information about the immunization of health care workers, attitudes and behaviors (Saglık c¸alıs¸anlarının ba˘gıs¸ıklanma ile ilgili bilgi düzeyleri, tutum ve davranıs¸ları), TAF Prev. Med. Bull. 14 (5) (2015).
http://dx.doi.org/10.1016/j.jcv.2016.08.170 Abstract no: 110 Presentation at ESCV 2016: Poster 131 Treatment of HIV and acute myeloid leukemia by allogeneic CCR5-d32 blood stem cell transplantation E. Knops 1,∗ , G. Kobbe 2 , R. Kaiser 1 , N. Luebke 2 , G. Dunay 3 , J. Fischer 2 , F. Huettig 2 , A. Wensing 4 , R. Haas 2 , M. Nijhuis 4 , J. Martinez-Picado 5 , D. Haeussinger 2 , B. Jensen 2 1
University of Cologne, Germany University of Duesseldorf, Germany 3 Leibniz Institute for Experimental Virology, Hamburg, Germany 4 Medical Center Utrecht, Netherlands 5 AIDS Research Institute irsiCaixa, Barcelona, Spain 2
The Berlin patient is presumed to be the only person cured from HIV-infection by hematopoietic stem cell transplantation (HSCT) from a homozygous CCR5-d32 donor. Attempts to reproduce cure by HSCT have failed because of either viral rebound or death due to the underlying malignancy. We here report a patient alive, well and negative for proviral DNA 900 days after HSCT. A 41 year old HIV-infected male patient was diagnosed acute myeloid leukemia (AML, inv16, CBF-MYH11) in 01/2011. Since the diagnosis of HIV-infection in 10/2010 he had been treated with TDF/FTC+ DRV (01/2011 VL 44 cop/mL; CD4+ 474 cells/l). To avoid interactions with chemotherapy DRV was switched to RAL in 03/2011. He achieved CR of the AML after 1 induction course (ICE) and received a 2nd induction and 3 consolidation courses according to AML-SG 07/04. In 09/2012 AML relapsed and he was treated with A-HAM and a 2nd cycle high-dose cytarabine. While in 2nd CR he received unmodified peripheral blood stem cells from a female 10/10 CCR5-d32 DKMS-donor after conditioning with fludarabine/treosulfan in 02/2013. Before transplant HIV resistance analysis was performed and viral tropism was determined. There were no significant resistance mutations and the coreceptor-usage was predicted as R5-tropic (Sanger sequencing: FPR 44.5%; NGS: 0.14% X4 at 3.5% FPR; geno2pheno). The proviral DNA load was 29400 cop/mL and in the western blot all anticipated bands could
be detected. During transplant and until today the patient remained on ART (since 06/2014 ABC/3TC/DTG) and the viral load remained undetectable in plasma and liquor. He had a 2nd relapse of AML in 06/2013 but re-entered molecular remission after a total of 8 courses of 5-azacytidine and 4 donor lymphocyte infusions. Concerning HIV, all collected samples were negative for proviral DNA by conventional and digital droplet PCR* in two different labs, namely PBMCs (06/2014, 01/2015* and 02/2015), rectal biopsy (04/2015) and bone marrow (08/2015*). Western blots from 06/2014 and 02/2015 showed incomplete patterns with fading bands. Like in the Berlin patient, all tests from the Duesseldorf patient so far suggest that HIV may have been eradicated and that he may be the second individual cured from HIV by allogeneic CCR5-d32 HSCT. Further investigations will be performed before considering the discontinuation of ART. http://dx.doi.org/10.1016/j.jcv.2016.08.171 Abstract no: 119 Presentation at ESCV 2016: Poster 132 Evaluation of the Aptima HIV-1 Quant Dx Assay using plasma and dried blood spots M. Sahoo ∗ , V. Varghese, E. White, Meg Winslow, D. Katzenstein, R. Shafer, B. Pinsky Stanford University School of Medicine, Stanford, CA, USA HIV-1 RNA quantitation in plasma, or virus load testing, is the primary method by which the response to antiretroviral therapy is monitored. In the current study, we describe the analytical and clinical evaluation of the Aptima® HIV-1 Quant Dx assay (Aptima) performed on the automated Panther® system. Using HIV-1 subtype B, Aptima had a dynamic range extending from 6.7 to 2.0 log10 copies/mL, the lower limit of 95% detection was <20 copies/mL, and within-laboratory precision at low virus loads ranged from percent coefficient of variation (CV) of 8.13% at 1.7 log10 copies/mL to 3.59% at 3.0 log10 copies/mL. The clinical performance of Aptima was compared to the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test v2.0 (CAP/CTM) using 162 EDTA plasma samples collected from patients undergoing HIV-1 monitoring. Overall agreement was 84.0% (136/162) with a kappa statistic of 0.723 (Standard Error 0.047; 95% CI 0.630–0.815) indicating substantial agreement. Using the 86 clinical samples quantifiable by both methods, Passing-Bablok regression revealed a regression line of Y = 1.069X − 0.346 [95% CI of the slope (1.003–1.139) and intercept (−0.666 to −0.074)] and Bland–Altman analysis demonstrated a mean difference (Aptima-CAP/CTM) of −0.075 log10 copies/mL (95% limits of agreement of −0.624 to 0.475), consistent with negative bias. Comparison of Aptima testing on paired dried blood spot (DBS) and plasma specimens archived from participants in the Peninsula AIDS Research Cohort Study (PARC) demonstrated an overall agreement of 94.7% (90/95) when 1000 copies/mL was used as threshold. In conclusion, the Aptima HIV-1 Quant Dx assay provides a suitable alternative for HIV-1 monitoring in plasma and DBS. http://dx.doi.org/10.1016/j.jcv.2016.08.172