INTRODUCTION: Hydatidiform mole (HM) is an abnormal gestation characterized by significant hydropic enlargement, trophoblastic proliferation and atypia involving part or all of the chorionic villi. The diagnosis and classification of hydatidiform moles is subject to great inter-observer variability due to significant morphologic overlaps. This study aims to evaluate the utility of p57KIP2 immunohistochemistry and ploidy by Her-2 FISH in refining the diagnosis of molar tissues.

METHOD: 113 and 78 molar cases were retrieved from the archives of the Histopathology Section of the Philippine General Hospital and Pathology Department of Seoul National University Hospital, respectively. TMA sections were submitted for immunohistochemical analysis for p57KIP2. Ploidy was determined by fluorescence in situ hybridization using Her-2 probe. An interrater reliability analysis was done using the Kappa statistics with 95% confidence interval.

RESULTS: All 68 (100%) cases diagnosed as CH were negative for p57KIP2 staining and are diploid. Among the 54 cases of PH, only 1 (2%) is positive for p57KIP2 and is diploid. The interrater reliability between p57KIP2 and Her-2 FISH ploidy results is 0.66 (p <.0.001), 95% CI (0.02, 1.00) which is considered "fair to good." The kappa value between review diagnosis and p57KIP2 is 0.024 while the kappa between review diagnosis and Her-2 FISH ploidy is 0.050 both signifying poor agreement beyond chance.

CONCLUSION: Morphologic assessment alone may not be sufficient in problematic cases. p57KIP2 in conjunction with by Her-2 FISH are good adjuncts in the diagnosis and classification of hydatidiform mole.

Human ; Male ; Female ; Pregnancy ; Chorionic Villi ; Immunohistochemistry ; In Situ Hybridization, Fluorescence ; Diploidy ; Reproducibility Of Results ; Hydatidiform Mole ; Trophoblasts ; Ploidies ; Molar

Objective. To determine the diagnostic accuracy of self-collected snorted and spit saliva in detecting COVID-19 using RT-PCR (ssRT-PCR) and lateral flow antigen test (ssLFA) versus nasopharyngeal swab RT-PCR (npRT-PCR). Methods. One hundred ninety-seven symptomatic subjects for COVID-19 testing in a tertiary hospital underwent snort-spit saliva self-collection for RT-PCR and antigen testing and nasopharyngeal swab for RT-PCR as reference. Positivity rates, agreement, sensitivity, specificity, and likelihood ratios were estimated. Results. Estimated prevalence of COVID-19 using npRT-PCR was 9% (exact 95% CI of 5.5% - 14.1%). A higher positivity rate of 13% in the ssRT-PCR assay suggested possible higher viral RNA in the snort-spit samples. There was 92.9% agreement between ssRT-PCR and npRT-PCR (exact 95% CI of 88.4% to 96.1%; Cohen’s Kappa of 0.6435). If npRT-PCR will be assumed as reference standard, the estimated Sensitivity was 83.3% (exact 95% CI of 60.8% to 94.2%), Specificity 93.9% (exact 95% CI of 89.3% to 96.5%), Positive predictive value of 57.7% (exact 95% CI of 38.9% to 74.5%), Negative predictive value of 98.2% (exact 95% CI of 95% to 99.4%), positive likelihood ratio of 3.65 (95% CI of 7.37 to 24.9), negative likelihood ratio of 0.178 (95% CI of 0.063 to 0.499). There was 84.84% agreement (95% exact CI of 79.1% to 89.5%; Cohen’s Kappa of 0.2356) between ssLFAvs npRT-PCR, sensitivity of 38.9% (exact 95% CI of 20.3% to 61.4%), specificity of 89.4% (exact 95% CI of 84.1% to 93.1%), PPV of 26.9% (95% CI of 13.7% to 46.1%), NPV of 93.6% (exact 95% CI of 88.8% to 96.4%), LR+ of 3.67 (95% CI of 1.79 - 7.51), LR – of 0.68 (95% CI of 0.47 - 0.99). Conclusion. Our data showed that snort-spit saliva RT-PCR testing had acceptable diagnostic performance characteristics and can potentially be used as an alternative to the standard nasopharyngeal/oropharyngeal swab RT-PCR test for COVID-19 in certain situations. However, our data also showed that snort-spit saliva antigen testing using lateral flow assay did not offer acceptable performance.
Saliva ; SARS-CoV-2 ; Reverse Transcription ; Reverse Transcriptase Polymerase Chain Reaction