Letters to the Editor
Steigman.
Maura Pieretti, PhD
Assistant Professor/Director Molecular Diagnostic Laboratory
Department of Pathology
University of South Alabama
Mobile, AL
References
Wright, et al. JAMA. 2002;287:2120-2129.
Lorincz, et al. The Lancet. 2002;360:228-229.
Dr. Vernicks reply:
Dr. Pierettis points of interest are duly noted. Whilst there may be clarification of the first issue, there are, alas, difficulties in publishing excellent current algorithms, such as that of the ASCCP, without copyright authorization. When writing on a vast current topic such as HPV DNA, it is often advantageous to convey concepts whilst focusing not on the prosaic molecular sequences but rather on the abstract principle, which in no way violates the integrity of the issue (as is appropriately illustrated in Figure 3, subsection 5). This helps clarify the emphasis and focus on the salient points for the readers who are professionals and have a sound scientific knowledge base. I am sure you would agree.
Disposal dilemma
I read in your April 2003 article under the section Addressing management issues the response to the question concerning disposing of sharps. It is my understanding, that sharps are from the cradle to the grave property. This means that the person generating the sharps is responsible for making arrangements for the sharps to be disposed. It is also my understanding that the physician who writes the prescription for the drug that requires the injection is responsible for making arrangements for the sharps to be disposed. An individual cannot create the need for a sharps [disposal container] because all injectable drugs are prescription-only. If a physician in a hospital orders the prescription, then the hospital is liable for disposal, even if the medicine is administered at home; but if the physician orders the meds from his office, then his office is responsible. If the needle is 27g or less and inch or less, it can be disposed in a puncture-proof container (coffee can, milk jug) in regular trash in our state. If this information is incorrect, I would like to know that it is and where the [correct] information can be found. I am the lab manager at a local health department, and I am constantly being confronted with this dilemma. I would like to know if I am giving patients incorrect information in directing them back to their primary care physician for disposal of their sharps.
Name withheld by request
Calibrating with different analyzers
I enjoyed the Q&A Comparing two analyzers (MLO, April 2003, p. 39). However, I would be very leery about using the assigned calibrator values of one manufacturer to calibrate a different brand of analyzer. Even various models of analyzers within a brand have different values assigned for a particular calibrator. A much better way, even with the same manufacturer, would be to calibrate the primary instrument with calibrator, then calibrate the second instrument against the first using whole blood. Instruments can react differently to calibrators, but much closer correlation may be achieved with this method.
Roy Midyett, MT (ASCP)
Presbyterian Intercommunity Hospital
Whittier, CA
© 2003 Nelson Publishing, Inc. All rights reserved.
Readers respond
Begging to differI applaud your choice of topic for the leading article of the March 2003 issue of MLO. As you point out, HPV DNA testing is revolutionizing current cervical cancer screening, and it is important to educate physicians and operators at all levels of this important innovation.However, I need to point out that the article by Drs. Vernick and Steigman contains various inaccuracies that may confuse the reader.HPV DNA-positive patients do not have a 96% prevalence of HSIL; what the authors may have been referring to is that HPV DNA testing has been proven to have a 96% sensitivity to detect CIN3+, as demonstrated by the ALTS Trial study (1), and as discussed by Dr. Cox at the CAP HPV meeting in September 2002.It is also extremely confusing to observe that the authors have chosen to refer to an old algorithm for the management of patients with ASC-US (published in JAMA 1999), while a more recent algorithm has been endorsed by the American Society for Colposcopy and Cervical Pathology.1 Significantly, this latter algorithm recommends the follow-up of women with a negative HPV DNA test with cytology at 12 months and not at a six-month interval.Furthermore, the authors refer to HPV viral loads measured in RLU per picogram. This is incorrect: viral load measurements with the Digene HCII test are, in fact, ratios representing RLU of sample/RLU of the mean of positive controls, where positive controls contain 1 pg/mL of HPV 16 DNA. Additionally, the interpretation of the referenced study on viral loads2 is incorrect; the study concludes that high viral loads do not predict the risk of CIN3+, while it does not address associations between HSIL and viral load, as quoted by Drs. Vernick andSteigman.
Maura Pieretti, PhD
Assistant Professor/Director Molecular Diagnostic Laboratory
Department of Pathology
University of South Alabama
Mobile, AL
References
Wright, et al. JAMA. 2002;287:2120-2129.
Lorincz, et al. The Lancet. 2002;360:228-229.
Dr. Vernicks reply:
Dr. Pierettis points of interest are duly noted. Whilst there may be clarification of the first issue, there are, alas, difficulties in publishing excellent current algorithms, such as that of the ASCCP, without copyright authorization. When writing on a vast current topic such as HPV DNA, it is often advantageous to convey concepts whilst focusing not on the prosaic molecular sequences but rather on the abstract principle, which in no way violates the integrity of the issue (as is appropriately illustrated in Figure 3, subsection 5). This helps clarify the emphasis and focus on the salient points for the readers who are professionals and have a sound scientific knowledge base. I am sure you would agree.
Disposal dilemma
I read in your April 2003 article under the section Addressing management issues the response to the question concerning disposing of sharps. It is my understanding, that sharps are from the cradle to the grave property. This means that the person generating the sharps is responsible for making arrangements for the sharps to be disposed. It is also my understanding that the physician who writes the prescription for the drug that requires the injection is responsible for making arrangements for the sharps to be disposed. An individual cannot create the need for a sharps [disposal container] because all injectable drugs are prescription-only. If a physician in a hospital orders the prescription, then the hospital is liable for disposal, even if the medicine is administered at home; but if the physician orders the meds from his office, then his office is responsible. If the needle is 27g or less and inch or less, it can be disposed in a puncture-proof container (coffee can, milk jug) in regular trash in our state. If this information is incorrect, I would like to know that it is and where the [correct] information can be found. I am the lab manager at a local health department, and I am constantly being confronted with this dilemma. I would like to know if I am giving patients incorrect information in directing them back to their primary care physician for disposal of their sharps.
Name withheld by request
Calibrating with different analyzers
I enjoyed the Q&A Comparing two analyzers (MLO, April 2003, p. 39). However, I would be very leery about using the assigned calibrator values of one manufacturer to calibrate a different brand of analyzer. Even various models of analyzers within a brand have different values assigned for a particular calibrator. A much better way, even with the same manufacturer, would be to calibrate the primary instrument with calibrator, then calibrate the second instrument against the first using whole blood. Instruments can react differently to calibrators, but much closer correlation may be achieved with this method.
Roy Midyett, MT (ASCP)
Presbyterian Intercommunity Hospital
Whittier, CA
© 2003 Nelson Publishing, Inc. All rights reserved.
