Layfield Lester J, Qureshi M Nasar
Department of Pathology, University of Utah School of Medicine and ARUP Laboratories, Salt Lake City, 84132, USA.
Diagn Cytopathol. 2005 Aug;33(2):138-43. doi: 10.1002/dc.20316.
Human papillomavirus (HPV) DNA testing for triage of cervical cytologies showing atypical squamous cells of undetermined significance (ASCUS) has become the standard of practice. Currently, Hybrid Capture II (HCII) is the preferred method for ASCUS triage. In situ hybridization for HPV represents an alternative to HCII and appears to have a superior specificity but is more expensive. We compare the reimbursement rates of ASCUS triage (HPV high risk) using the methods of HCII and INFORM (in situ hybridization for HPV) in a series of 431 ASCUS patients. The patients were followed for 1 yr, during which each patient had either colposcopic biopsy or follow-up cervical cytology after ASCUS HPV DNA triage. Eighty-nine patients were excluded from the analysis because of incomplete follow-up. The HPV triage percentages, colposcopic biopsy positivity rates and cervical cytology positivity percentages were calculated for each method. The reimbursement rates of the tests/procedures used in the analysis were those in effect at the University of Utah in 2003. The total triage and follow-up reimbursement costs were calculated for HCII and INFORM and compared.HCII referred 19.9% of patients to colposcopy, with a biopsy positivity rate of 25.6% for dysplasia. INFORM referred 11.8% of patients to colposcopy, of whom 34% had a biopsy diagnosis of dysplasia. HCII negative cases revealed 19% to have ASCUS or higher on the follow-up cervical cytology, while 19.9% of INFORM negative cases had a reading of ASCUS or higher at follow-up cytologic examination. The 1-yr HPV DNA triage and follow-up reimbursements for HCII were 316,942.00 US dollars per 1,000 women, and for the INFORM methodology, the reimbursements were 369,484.00 US dollars per 1,000 women. The INFORM method was associated with higher specificity and sent fewer (41%) patients to colposcopy than did HCII. Although this smaller referral rate reduced reimbursement costs associated with colposcopy, the increased reimbursement paid for follow-up cytologies and office visits of HPV DNA negative patient and the greater cost of the INFORM test results in higher overall reimbursement for INFORM. Based on these costs and diagnostic accuracies, it appears that the INFORM HPV technology represents a viable option to HCII ASCUS triage. INFORM HPV appears to be 16% more expensive than HCII but has the advantage of sending 41% fewer women to colposcopy.
人乳头瘤病毒（HPV）DNA检测用于对显示意义不明确的非典型鳞状细胞（ASCUS）的宫颈细胞学检查结果进行分流，已成为标准的诊疗方法。目前，第二代杂交捕获法（HCII）是ASCUS分流的首选方法。HPV原位杂交是HCII的一种替代方法，其特异性似乎更高，但成本更高。我们比较了在431例ASCUS患者中使用HCII和INFORM（HPV原位杂交）方法进行ASCUS分流（HPV高危型）的报销率。对患者进行了1年的随访，在此期间，每位患者在ASCUS HPV DNA分流后接受了阴道镜活检或后续宫颈细胞学检查。由于随访不完整，89例患者被排除在分析之外。计算了每种方法的HPV分流百分比、阴道镜活检阳性率和宫颈细胞学阳性百分比。分析中使用的检查/程序的报销率为2003年犹他大学的实际报销率。计算并比较了HCII和INFORM的总分流和随访报销成本。HCII将19.9%的患者转诊至阴道镜检查，发育异常的活检阳性率为25.6%。INFORM将11.8%的患者转诊至阴道镜检查，其中34%的患者活检诊断为发育异常。HCII阴性病例中，19%在后续宫颈细胞学检查中显示为ASCUS或更高级别，而INFORM阴性病例中，19.9%在后续细胞学检查中显示为ASCUS或更高级别。HCII每1000名女性的1年HPV DNA分流和随访报销费用为316,942.00美元，而INFORM方法的报销费用为每1000名女性369,484.00美元。INFORM方法具有更高的特异性，与HCII相比，转诊至阴道镜检查的患者更少（41%）。虽然这种较低的转诊率降低了与阴道镜检查相关的报销成本，但HPV DNA阴性患者的后续细胞学检查和门诊就诊的报销费用增加，以及INFORM检测成本更高，导致INFORM的总体报销费用更高。基于这些成本和诊断准确性，INFORM HPV技术似乎是HCII ASCUS分流的一个可行选择。INFORM HPV似乎比HCII贵16%，但具有将转诊至阴道镜检查的女性减少41%的优势。
