992 Correspondence / American Journal of Emergency Medicine 31 (2013) 983-994

creatinine is a well-known unfavorable prognostic parameter in AP. Elevated creatinine at 48 hours after admission was recently described as a marker for pancreatic necrosis. As pancreatic necrosis is a serious complication of AP and its identification by a simple single laboratory test would be very helpful, an elevated serum creatinine concentration at any time during the first 48 hours of admission is not a marker for pancreatic necrosis in a first attack of AP [11]. Recently, several laboratory markers including hematocrit, matrix metallopro- teinase-9, and serum amyloid A have been used as early predictors of severity within the first 24 hours. In addition, not only RDW but also neutrophil lymphocyte ratio, Uric acid, a ?-glutamyltransferase [12], and mean platelet volume are easy methods to assess the Metabolic syndrome of the obesity patients [13]. These markers might be useful in clinical practice [14]. Finally, it would be better if the authors might define how much time they specified on measuring RDW levels because delaying blood sampling can cause abnormal results in RDW measurements.

inappropriate use of qualitative, point-“>In conclusion, we strongly believe that those findings obtained from the current study will lead to further large scale studies examining the relationship between RDW and AP. However, one should keep in mind that RDW itself alone without other inflamma- tory markers may not give exact information to clinicians about the inflammatory status and prognostic indication of the patients. So, from that point of view, we think that it should be evaluated accompanied with other serum inflammatory markers.

Sevket Balta MD Sait Demirkol MD Department of Cardiology Gulhane Medical Academy 06018 Etlik-Ankara, Turkey

E-mail address: [email protected]

Mustafa Cakar MD Department of Internal Medicine Gulhane Medical Academy 06018 Etlik-Ankara, Turkey

Sukru Ardic MD Department of Emergency Medicine Gulhane Medical Academy

06018 Etlik-Ankara, Turkey

Turgay Celik MD Department of Cardiology Gulhane Medical Academy 06018 Etlik-Ankara, Turkey

Seref Demirbas MD Department of Internal Medicine Gulhane Medical Academy 06018 Etlik-Ankara, Turkey

http://dx.doi.org/10.1016/j.ajem.2013.02.037

References

1. Senol K, Saylam B, Kocaay F, Tez M. red cell distribution width as a predictor of mortality in acute pancreatitis. Am J Emerg Med 2013:2012-4 [Elsevier Inc.].
2. Jo YH, Kim K, Lee JH, Kang C, Kim T, Park H-M, et al. Red cell distribution width is a prognostic factor in severe sepsis and septic shock. Am J Emerg Med 2013;31: 545-8.
3. Lee JH, Chung HJ, Kim K, Jo YH, Rhee JE, Kim YJ, et al. Red cell distribution width as a prognostic marker in patients with community-acquired pneumonia. Am J Emerg Med 2013;31(1):72-9.
4. Grant BJB, Kudalkar DP, Muti P, McCann SE, Trevisan M, Freudenheim JL, et al. Relation between lung function and RBC distribution width in a population-based study. Chest 2003;124(2):494-500.
5. Isman FK, Zulfikaroglu B, Isbilen B, Ozalp N, Ozmen MM, Bilgic I, et al. Copeptin is a predictive biomarker of severity in acute pancreatitis. Am J Emerg Med 2013 [Epub ahead of print].
6. Bezmarevic M, Mirkovic D, Soldatovic I, Stamenkovic D, Mitrovic N, Perisic N, et al. Correlation between procalcitonin and intra-abdominal pressure and their role in prediction of the severity of acute pancreatitis. Pancreatology 2012;12(4): 337-43.
7. Zhao X, Chang Mei H, Chen L, Jiang L, He M, et al. An increased level of haemoglobin A1C predicts a poorer clinical outcome in patients with acute pancreatitis. Clin Endocrinol (Oxf) 2012;77(2):241-5.
8. Ke L, Ni H-B, Tong Z-H, Li W-Q, Li N, Li J-S. D-dimer as a marker of severity in patients with Severe acute pancreatitis. J Hepatobiliary Pancreat Sci 2012;19(3):259-65.
9. Nadkarni N, Bhasin DK, Rana SS, Bahl A, Sinha SK, Rao C, et al. diastolic dysfunction, prolonged QTc interval and pericardial effusion as predictors of mortality in acute pancreatitis. J Hepatobiliary Pancreat Sci 2012;27(10): 1576-80.
10. Kocak E, Koklu S, Basar O, Yilmaz FM, Ciftci A, Kaya C, et al. Evaluation of serum TWEAK concentration in patients with acute pancreatitis. Scand J Clin Lab Invest 2012;72(3):192-6.
11. Lankisch PG, Weber-Dany B, Maisonneuve P, Lowenfels AB. High serum creatinine in acute pancreatitis: a marker for pancreatic necrosis? Am J Gastroenterol 2010;105(5):1196-200.
12. Kong APS, Choi KC, Ho CS, Chan MHM, Ozaki R, Chan CWH, et al. Associations of uric acid and gamma-glutamyltransferase (GGT) with obesity and components of metabolic syndrome in children and adolescents. Int J Pediatr Obes 2012 [Epub ahead of print].
13. Demirkol S, Balta S, Unlu M, Yuksel UC, Celik T, Arslan Z, et al. Evaluation of the mean platelet volume in patients with cardiac syndrome X. Clinics (Sao Paulo) 2012;67(9):1019-22.
14. Demirkol S, Balta S, Unlu M, Arslan Z, Cakar M, Kucuk U, et al. Neutrophils/lym- phocytes ratio in patients with cardiac syndrome X and its association with carotid intima-media thickness. Clin Appl Thromb Hemost 2012 [Epub ahead of print].

    Inappropriate use of qualitative, point-of-care urine human chorionic gonadotropin test?

    To the Editor,

    We read with interest the case report by Habboushe and Walker

    [1] that described the use of whole blood instead of urine or serum for the qualitative detection of human chorionic gonadotropin (hCG) in a patient with a ruptured Ectopic pregnancy.

    The authors acknowledge that the use of whole blood for qualitative hCG testing has not been studied or evaluated for accuracy, yet they do not mention that any modification of the Intended use of a Food and Drug Administration -approved, in vitro diagnostic test and subsequent use for patient testing is against the law without appropriate validation experiments. Indeed, federal and New York state (the authors practice medicine in NY) regulations are quite clear in this requirement [2,3]. The use of a sample type that is not specified in the test manufacturer’s product insert is considered to be a test modification.

    We believe that the authors were unaware of federal and state laboratory regulations regarding the utilization of test results from modified FDA-approved tests to manage their patient. Likewise, the Review process also failed to recognize the conflict with the same long-standing regulations before publication, leading to what appears to be the promotion of an unauthorized practice with serious patient safety risks.

    We agree that blood-based hCG tests offer several advantages over Urine tests. Quantitative blood-based hCG tests are typically per- formed in a central laboratory, and the time required to report results may be considerably longer; therefore, despite their limitations, qualitative urine hCG tests are routinely used in emergency settings to assess pregnancy status at the point of care.

    Nevertheless, changing the sample requirements of an FDA-cleared assay is not permitted without appropriate validation and can have

    ? Sources of support: None.

    Correspondence / American Journal of Emergency Medicine 31 (2013) 983-994 993

    severe consequences beyond the regulatory risk of losing laboratory accreditation. The safety implications of such practices should not be underestimated. For example, a false positive may lead to patients being sent to surgery unnecessarily, whereas a false negative may dismiss the possibility a life-threatening ectopic pregnancy. Fortu- nately, this patient was not harmed.

    Although it can be tempting to adapt the intended use of diagnostic tests to fit specific clinical needs, to do so without input and guidance from clinical laboratory professionals is risky and unlawful. We encourage the authors to reach out to their clinical colleagues in the laboratory to identify appropriate solutions for clinical dilemmas, and we recommend that the journal identify reviewers with the knowledge and expertise to appropriately consider issues related to laboratory testing.

    David G. Grenache PhD, DABCC

    Department of Pathology, University of Utah School of Medicine

    Salt Lake City, UT 84112, USA E-mail address: [email protected]

    Ann M. Gronowski PhD, DABCC

    Department of Pathology and Immunology Washington University School of Medicine, St Louis, MO 63021, USA

    Corinne R. Fantz PhD, DABCC

    Department of Pathology and Laboratory Medicine Emory University School of Medicine, Atlanta, GA 30308, USA

    http://dx.doi.org/10.1016/j.ajem.2013.02.041

    References

    Habboushe JP, Walker G. Novel use of a urine pregnancy test using whole blood. Am J Emerg Med 2011;29(7):840-844.e3.

15. Centers for Medicare and Medicaid Services, Clinical Laboratory Improvement Amendments (http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA). Accessed January 31, 2013.
16. New York State Department of Health, Wadsworth Center, Division of Laboratory Quality Certification (http://www.wadsworth.org/docs/overview_lab_quality. shtml). Accessed January 31, 2013.

    Response to a letter titled “Inappropriate use of qualitative, point-of-care urine hCG test”?

    To the Editor,

    We appreciate the writer’s comments. However, we question their applicability to the physician at the bedside. There are numerous examples of unapproved uses of medications, devices, and diagnostics immediately familiar to the practicing physician. Physicians’ judg- ment is relied upon to determine when benefit to the patient outweighs the risk of inaccuracy of unapproved use.

    We have always found it wise to be measured in our allegations of illegality, particularly when referring to a physician’s Scope of practice rather than regulations that apply to an accredited laboratory. We disagree that our case report represents “the promotion of an unauthorized practice with serious patient safety risks,” because this critically ill, hypotense, ultrasound FAST-positive patient would undoubtedly require a visit to the operating room. This test simply assisted the clinician to consult ob-gyn faster.

    ? There is no funding, outside support, or financial interest. We are the original authors of “Novel Use of a Urine Pregnancy Test Using Whole Blood,” about which the

    In any case, our uncontrolled observation has apparently been corroborated recently [1].

    Joseph P. Habboushe MD, MBA

    Beth Israel Medical Center of the Albert Einstein College of Medicine

    New York, NY 10003, USA

    E-mail address: [email protected]

    Graham Walker MD

    Department of Emergency Medicine, Kaiser Permanente

    Oakland, CA, USA

    http://dx.doi.org/10.1016/j.ajem.2013.02.040

    Reference

    Fromm C, et al. Substituting whole blood for urine in a bedside pregnancy test. Novel use of a urine pregnancy test using whole blood. J Emerg Med 2012;43(3): 478-82.

    A new algorithm in the chest pain unit using the High-sensitivity troponin T?

    To The Editor,

    The Chest Pain Unit was designed to improve the management of patients with acute chest pain in the Emergency Department (ED) [1]. The objective of our study is to validate a new algorithm, which has been applied in our center since 2012. This includes the measurement of high-sensitivity troponin T in patients with an Initial diagnosis of “doubtful” acute coronary syndrome (doubtful angina plus electro-

    cardiogram without Ischemic changes).

    Nine hundred twenty-six patients were evaluated in the ED with a chest pain, and a total of 300 patients (32.3%) were included prospectively and consecutively in the chest pain unit. They were evaluated by performing medical interview, physical examination, electrocardiogram, chest radiography, and high-sensitivity troponin T. Patients with a greater value than 14 ng/mL were admitted with a diagnosis of acute coronary syndrome. In accordance with the international recommendations, when the patient felt the chest pain before the last 6-hour period prior to admission to the ED, only one serum plasma of high-sensitivity troponin T of less than 14 ng/mL is

    enough to discharge the patient.

    If the patient felt the chest pain within the last 6 hours prior to admission, it is necessary to give two serum plasma of troponin T, intake being separated by 3 hours.

    If the patient was part of populations with chronic elevations of troponin, such as patients with coronary disease, poorly controlled hypertension, over 70 years old, with chronic heart failure or failure renal function, the result expected a second dosage for defining behavior [2,3]. The second serum plasma of troponin T was performed three hours later with respect to the first serum plasma to have a good sensitivity and adequate variability curve. We considered an acute coronary syndrome in this special population when there was an increase of more than 7 ng/mL compared to the first result, based on the study by Reichlin et al, where it was seen that the absolute variation has better accuracy than the relative variation for the

    diagnosis of acute myocardial infarction [4].

    We also diagnosed acute coronary syndrome during the observa- tion, in the presence of one of the conditions of the following criteria:

    letter was written. ? Conflicts of Interest: We do not have conflict of interest.