Objectives
Boston Medical Center (BMC) is a private, not-for-profit 514-bed academic medical center and legacy safety net hospital serving a diverse global patient population. BMC recently implemented a new HIV-1/HIV-2 Qualitative RNA PCR (HIV RNA QUAL) cleared by the US Food and Drug Administration to (1) replace antibody discrimination follow-up testing after a reactive fourth-generation (4G) serology screen and (2) use as a stand-alone diagnostic for suspected seronegative acute HIV infection.
Methods
This report summarizes the results of a production monitor for the first 3 months postimplementation.
Results
The monitor characterized test utilization, diagnostic turnaround time, impact on send-out testing, results reflexed to HIV RNA discrimination follow-up, and discrepancies between screening and HIV RNA results that necessitated additional investigation. Another element was the novelty of using HIV RNA QUAL while awaiting the existing Centers for Disease Control and Prevention HIV testing algorithm update. The 4G screening components and the HIV RNA QUAL were also used to create an algorithm specific to and compliant with current guidelines for screening patients on HIV preexposure prophylaxis.
Conclusions
Based on our findings, this new test algorithm may be reproducible and instructive at other institutions.
Background
Determining human papillomavirus (HPV) status in oropharyngeal squamous cell carcinoma can have a significant impact on treatment and clinical outcomes. Because fine‐needle aspiration (FNA) is typically an initial diagnostic modality in a patient workup for primary or suspected metastatic disease, immunostaining for p16 on FNA material is a promising option to determine HPV tumor status, possibly avoiding biopsies or excisions. In this study, the authors investigated the possibility of using alcohol‐fixed smears as a reliable alternative for reporting p16 status.
Methods
Twenty HPV‐associated tumors and 20 non‐HPV–associated tumors were identified using the gold‐standard histologic cutoff for positivity of ≥70% strong nuclear and cytoplasmic staining. Matched FNA specimens were identified for comparison staining, and a positive p16 result was rendered on a single aspirate smear using the same cutoff of ≥70%.
Results
On alcohol‐fixed cytology smears, 16 of 20 (80%) HPV‐associated tumors showed positive p16 staining in ≥70% tumor cells. Four cases showed lower level (30%‐60%) nuclear and cytoplasmic staining. Nineteen of 20 (95%) non‐HPV–associated tumors showed no or minimal p16 staining (0%‐10%), and 1 case had a p16‐equivocal cytology result.
Conclusions
The authors performed immunocytochemical validation for p16 using alcohol‐fixed smears and observed promising results, offering this technique as a potential alternative to formalin‐fixed tissue in the appropriate clinical context. By using a positive staining cutoff of ≥70%, this technique offers 80% sensitivity and 95% specificity for detecting HPV‐associated tumors. Although it was not performed in the current study, HPV‐specific testing on available formalin‐fixed, paraffin‐embedded tissue should be considered in cases with equivocal or negative p16 staining.
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