Real-Life Sensitivity and Specificity of a COVID-19 Ag Rapid Test Device in Haematology-Oncology Cases in a Tertiary-Care Educational University Hospital
Makaleler > Tam Makale · 2025
Yazarlar: Umran Elbahr, Nafisa Alwazzan, Oğuz Reşat SİPAHİ, Jennie Pastrana, Chithra Vineeth, Suha Hejres, Tarkan Yetisyigit, Shruti Prem Sudha, Zainab Ibrahim, Elias Fadel, Oğuz Reşat SİPAHİ
FLORA INFEKSIYON HASTALIKLARI VE KLINIK MIKROBIYOLOJI DERGISI, ESCI İndekslerine Giren Dergi, Uluslararası, Wos, 2025, cilt 30, ss 53-59
Özet
Introduction: The Panbio (TM) coronavirus diseases-2019 (COVID-19) antigen rapid test device (PANCOVIDRTD, Abbott Germany) is commonly used in our setting. According to the manufacturer, its sensitivity, specificity, and agreement are 98.1%, 99.8%, and 99.4% respectively when compared to polymerase chain reaction (PCR) as the golden standard. We aimed to investigate these parameters of PANCOVIDRTD in hematology-oncology patients, who may have different viral loads due to their immunosuppressive conditions. Materials and Methods: Our setting is a 164-bed educational hemato-oncology hospital. This study encompassed all patients who underwent PCR and PANCOVIDRTD testing from May to October 2022. The sensitivity and specificity of PANCOVIDRTD were evaluated with PCR as the reference standard. Results: A total of 227 patients (122 patients with PCR positivity and 105 patients with PCR negativity) were included in the study. The mean age was 56 +/- 14 years. One hundred forty six (64%) were female. Thirty-seven patients (16.2%) had hematologic underlying diseases, while 190 patients (83.7%) had oncologic underlying diseases. On the test day, 124 (54.6%) patients were symptomatic and 103 (52.4%) were asymptomatic for COVID-19. In the entire study group, PANCOVIDRTD demonstrated a sensitivity of 79.5% (97/122), a specificity of 100% (105/105), and an overall agreement rate of 89% (202/227). Within the symptomatic group, PANCOVIDRTD exhibited a sensitivity of 82% (73/89), a specificity of 100% (35/35), and an overall agreement of 87.1% (108/124). Conversely, in the asymptomatic subgroup, these values were 72.7% (24/33) for sensitivity, 100% (70/70) for specificity, and 91.2% (94/103) for overall agreement. The positivity rates of PANCOVIDRTD for samples with Ct values >= 30, >= 25 to <30, and 20 to <25 were 67.5% (27/40), 84.7% (39/46), and 85.7% (30/35), respectively. Conclusion: The real-life sensitivity of PANCOVIDRTD in the hemato-oncology patient group was approximately 80%, rather than 95+%, while its specificity closely aligned with the manufacturer's reported results.