Cost-benefit analysis of two quality control approaches for infectious disease testing

Authors: Dimech, Wayne ^{1, ⁎}, Mitchell, Patricia ², Vincini, Giuseppe ¹

Source: In Pathology January 2025

Evidence-based assessment of the application of Six Sigma to infectious disease serology quality control.

Authors: Dimech, Wayne¹ (AUTHOR) wayne@nrlquality.org.au, Vincini, Giuseppe¹ (AUTHOR)

Source: Clinical Chemistry & Laboratory Medicine. May2025, Vol. 63 Issue 6, p1228-1236. 9p.

Subject Terms: *SIX Sigma, *QUALITY control, *SEROLOGY, *STATISTICAL bias, *STANDARDIZATION, *COMMUNICABLE diseases, *DEVIATION (Statistics), *BIOLOGICAL assay

Real-world trends in incidence of bacterial sexually transmissible infections among gay and bisexual men using HIV pre-exposure prophylaxis (PrEP) in Australia following nationwide PrEP implementation: an analysis of sentinel surveillance data

Authors: Asselin, Jason, Bastian, Lisa, Bateson, Deborah, Bowden, Scott, Boyd, Mark, Callander, Denton, Carter, Allison, Cogle, Aaron, Costello, Jane, Dimech, Wayne, Dittmer, Jennifer, Donovan, Basil, El-Hayek, Carol, Ellard, Jeanne, Fairley, Christopher, Franklin, Lucinda, Guy, Rebecca, Hellard, Margaret, Hocking, Jane, Kim, Jules, McGill, Scott, Nolan, David, Patel, Prital, Pendle, Stella, Polkinghorne, Victoria, Nguyen, Long, Nguyen, Thi, O'Connor, Catherine, Reed, Philip, Roth, Norman, Ryder, Nathan, Selvey, Christine, Stoové, Mark, Traeger, Michael William, Vickers, Toby, Walker, Melanie, Watchirs-Smith, Lucy, West, Michael, Traeger, Michael W ^*, Wright, Edwina J, Grulich, Andrew, McManus, Hamish, Fairley, Christopher K, Chow, Eric P F, McNulty, Anna, Finlayson, Robert, Bell, Charlotte, Owen, Louise, Marshall, Lewis, Russell, Darren, O'Donnell, Darryl, Hellard, Margaret E ^*, Stoové, Mark A ^*

Source: In The Lancet Infectious Diseases August 2022 22(8):1231-1241

Point-of-care testing: state-of-the art and perspectives.

Authors: Plebani, Mario, Nichols, James H., Luppa, Peter B., Greene, Dina, Sciacovelli, Laura, Shaw, Julie, Khan, Adil I., Carraro, Paolo, Freckmann, Guido, Dimech, Wayne, Zaninotto, Martina, Spannagl, Michael, Huggett, Jim, Kost, Gerald J., Trenti, Tommaso, Padoan, Andrea, Thomas, Annette, Banfi, Giuseppe, Lippi, Giuseppe

Source: Clinical Chemistry & Laboratory Medicine; Jan2025, Vol. 63 Issue 1, p35-51, 17p

Subject Terms: RAPID diagnostic tests, DISRUPTIVE innovations, POINT-of-care testing, CLINICAL pathology, CONFORMANCE testing

Validation of Dried Tube Sample Format Quality Controls for the Monitoring of Viral Load and Blood Screening Assays

Authors: Dimech, Wayne ^*, Vincini, Giuseppe, Davies, Kylie, Karakaltsas, Marina, van Cauwalaert, Natasha Dubois, Guichet, Emilande, Koppelman, Marco, Cabuang, Liza

Source: In Journal of Virological Methods November 2020 285

Improving the coverage and accuracy of syphilis testing: The development of a novel rapid, point-of-care test for confirmatory testing of active syphilis infection and its early evaluation in China and South Africa

Authors: Pham, Minh D., Wise, Amy, Garcia, Mary L., Van, Huy, Zheng, Shuning, Mohamed, Yasmin, Han, Yan, Wei, Wan-Hui, Yin, Yue-Ping, Chen, Xiang-Sheng, Dimech, Wayne, Braniff, Susie, Technau, Karl-Günter, Luchters, Stanley, Anderson, David A.

Source: In eClinicalMedicine July 2020 24

WHO international standard for anti-rubella: learning from its application

Authors: Kempster, Sarah L ^*, Almond, Neil, Dimech, Wayne, Grangeot-Keros, Liliane, Huzly, Daniela, Icenogle, Joseph, El Mubarak, Haja Sittana, Mulders, Mick N, Nübling, C Micha

Source: In The Lancet Infectious Diseases January 2020 20(1):e17-e19

Rubella Serology: A Renewed Call to Action.

Authors: Dimech, Wayne¹

Source: Archives of Pathology & Laboratory Medicine. Jan2025, Vol. 149 Issue 1, p7-7. 1p.

Subject Terms: *VIRAL antibodies, *MEDICAL protocols, *IMMUNIZATION, *RUBELLA, *SEROLOGY, *GENETIC disorders, *VACCINE hesitancy, *SERODIAGNOSIS, *MEDICAL laboratories, *QUALITY assurance, *BIOLOGICAL assay, *RUBELLA vaccines

Company/Entity: UNITED States. Food & Drug Administration , CENTERS for Disease Control & Prevention (U.S.)

Results of cytomegalovirus DNA viral loads expressed in copies per millilitre and international units per millilitre are equivalent

Authors: Dimech, Wayne, Cabuang, Liza M., Grunert, Hans-Peter, Lindig, Vanessa, James, Vivienne, Senechal, Brigitte, Vincini, Giuseppe A., Zeichhardt, Heinz

Source: In Journal of Virological Methods February 2018 252:15-23

Implementation of Novel Quality Assurance Program for Hepatitis C Viral Load Point of Care Testing.

Authors: Dimech, Wayne¹ (AUTHOR) wayne@nrlquality.org.au, Cabuang, Liza¹ (AUTHOR), Davies, Kylie¹ (AUTHOR), Vincini, Giuseppe¹ (AUTHOR)

Source: Viruses (1999-4915). Sep2022, Vol. 14 Issue 9, p1929-N.PAG. 11p.

Subject Terms: *POINT-of-care testing, *VIRAL hepatitis, *QUALITY assurance, *HEPATITIS C virus, *VIRAL load, *QUALITY control, *HEPATITIS C

A 16-year review of seroprevalence studies on measles and rubella

Authors: Dimech, Wayne, Mulders, Mick N.

Source: In Vaccine 29 July 2016 34(35):4110-4118

A review of testing used in seroprevalence studies on measles and rubella

Authors: Dimech, Wayne, Mulders, Mick N.

Source: In Vaccine 29 July 2016 34(35):4119-4122

A national programme to scale-up decentralised hepatitis C point-of-care testing and treatment in Australia

Authors: Hosseini-Hooshyar, Samira, Sheehan, Yumi, Shaw, Ineke, Cunningham, Philip, Fowlie, Carrie, Marshall, Alison D, Byrne, Marianne, Treloar, Carla, Shih, Sophy TF, Gray, Richard T, Wiseman, Virginia, Applegate, Tanya L, Guy, Rebecca, Martinello, Marianne, Hajarizadeh, Behzad, Lafferty, Lise, Dimech, Wayne, Cabuang, Liza, Dawson, Olivia, Read, Philip, Pedrana, Alisa, Thompson, Alexander J, O'Loan, Joss, Grebely, Jason, Markus, Corey, Causer, Louise M, Silk, David, Comben, Simon, Lloyd, Andrew R, Martinez, Maria, Cunningham, Evan B, O'Flynn, Mim, Dore, Gregory J, Matthews, Susan

Source: In The Lancet Gastroenterology & Hepatology March 2023 8(3):204-207

Quality control and external quality assessment for the independent clinic-based evaluation of point-of-care testing to detect Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in eight countries.

Authors: Shephard, Mark, Matthews, Susan, Andrewartha, Kelly, Dimech, Wayne, Cabuang, Liza, Barbara, Christopher, Chen, Xiang-Sheng, Cordioli, Maddalena, Hançali, Amina, Jiang, Ting-Ting, Kularatne, Ranmini, Meli, Stephanie, Muller, Etienne, Oumzil, Hicham, Padovese, Valeska, Sandri, Angela, Vargas, Silver, Zahra, Graziella, Unemo, Magnus, Blondeel, Karel

Source: BMC Infectious Diseases; 2/29/2024, Vol. 24 Issue 1, p1-10, 10p

Subject Terms: TRICHOMONAS vaginalis, NEISSERIA gonorrhoeae, CHLAMYDIA trachomatis, QUALITY control, SEXUALLY transmitted diseases

Geographic Terms: SUNNYVALE (Calif.)

Company/Entity: WORLD Health Organization

Tracking the uptake of outcomes of hepatitis B virus testing using laboratory data in Victoria, 2011-16: a population-level cohort study.

Authors: van Gemert, Caroline^1,2 (AUTHOR) caroline.vangemert@burnet.edu.au, Dimech, Wayne³ (AUTHOR), Stoove, Mark^1,2 (AUTHOR), Guy, Rebecca⁴ (AUTHOR), Howell, Jess^1,5 (AUTHOR), Bowden, Scott⁶ (AUTHOR), Nicholson, Suellen⁶ (AUTHOR), Pendle, Stella⁷ (AUTHOR), Donovan, Basil⁴ (AUTHOR), Hellard, Margaret^1,2 (AUTHOR), ACCESS collaboration (CORPORATE AUTHOR)

Source: Sexual Health (14485028). 2019, Vol. 16 Issue 4, p358-366. 9p.

Evaluation of a multiplex flow cytometric immunoassay to detect PR3- and MPO-ANCA in active and treated vasculitis, and in inflammatory bowel disease (IBD)

Authors: Trevisin, Michelle, Pollock, Wendy, Dimech, Wayne, Savige, Judy

Source: In Journal of Immunological Methods 31 July 2008 336(2):104-112

Time to address quality control processes applied to antibody testing for infectious diseases.

Authors: Dimech, Wayne J.¹ (AUTHOR) wayne@nrlquality.org.au, Vincini, Giuseppe A.¹ (AUTHOR), Plebani, Mario² (AUTHOR), Lippi, Giuseppe³ (AUTHOR), Nichols, James H.⁴ (AUTHOR), Sonntag, Oswald⁵ (AUTHOR)

Source: Clinical Chemistry & Laboratory Medicine. 2023, Vol. 61 Issue 2, p205-212. 8p.

Subject Terms: *COMMUNICABLE diseases, *ANTIBODY titer, *QUALITY control, *CLINICAL chemistry, *IMMUNOGLOBULINS, *TEST systems

Company/Entity: WORLD Health Organization

Response to Tony Badrick regarding "Letter to the Editor regarding the article by Wayne J. Dimech et al. Time to address quality control processes applied to antibody testing for infectious diseases. Clin Chem Lab Med 2023; 61(2):205–212 by".

Authors: Dimech, Wayne J.¹ (AUTHOR) wayne@nrlquality.org.au, Vincini, Giuseppe A.² (AUTHOR), Plebani, Mario³ (AUTHOR), Lippi, Giuseppe⁴ (AUTHOR), Nichols, James H.⁵ (AUTHOR), Sonntag, Oswald⁶ (AUTHOR)

Source: Clinical Chemistry & Laboratory Medicine. Jul2023, Vol. 61 Issue 8, pe137-e139. 3p.

Subject Terms: *ANTIBODY titer, *COMMUNICABLE diseases, *QUALITY control

Policy analysis: User monitoring of in-vitro diagnostic medical devices used for near-patient testing of infectious diseases.

Authors: Dimech, Wayne, Lamoury, Francois, Ding, Xavier C, Lastra, Leticia Megias, Vincini, Giuseppe, Sands, Anita

Source: IJQHC Communications; 2022, Vol. 2 Issue 2, p1-6, 6p

Assessment of Performance and Uncertainty in Qualitative Chemical Analysis. (German)

Authors: Hibbert, Brynn, Lin, Teo Tang, Bettencourt, Ricardo, Ellison, Stephen R., Theodorsson, Elvar, Pereira, Paulo, Kennedy, Melissa, Dimech, Wayne

Source: Chemistry International; Jan2023, Vol. 45 Issue 1, p46-50, 5p