Evaluation of ELISA and Real-Time PCR Results Sent for The Diagnosis of Cytomegalovirus (CMV) İnfection

Abstract

AİM: Human Cytomegalovirus (CMV) is an enveloped virus with a linear double-stranded DNA genome and an icosahedral capsid, belonging to the Betaherpesvirinae subfamily of the Herpesviridae family. While it is rarely pathogenic in immunocompetent individuals, CMV poses a significant health threat to immunocompromised patients. Due to the strong association between CMV infection and decreased patient survival, the monitoring and treatment of CMV infection are crucial. In immunosuppressed individuals, serological test results have significant limitations in diagnosing acute CMV infection; in such cases, the detection of viral nucleic acid, most commonly by polymerase chain reaction (PCR), is used to confirm the presence of CMV. There are limited studies investigating the correlation between these two testing methods. Therefore, this study aims to comparatively evaluate CMV antibody and CMV DNA test results. MATERIAL AND METHODS: The Bosphore CMV quantification kit was used in the PCR phase. CMV-IgM and CMV-IgG antibody levels were analyzed using the ELISA method (Cobas E 411/Roche) according to the procedure described by the manufacturer. RESULTS: In 81% of the samples (298/367), the results are consistent; both test results were negative in 280 (76.2%) samples and positive in 18 (4.9%) samples. It was found that 92.7% of the 302 patients who tested negative for IgM were also negative for CMV-PCR. Only 45% of the 40 patients who tested positive for CMV-PCR were identified as positive by the IgM test. Statistical analysis shows that there is a significant difference in the detection rates of this pathogen between the two tests (p < 0.001). CONCLUSIONS: There is a strong concordance between the negative results of both tests; however, the same concordance has not been observed among positive results. Overall, further studies involving larger patient cohorts are recommended to improve CMV management strategies in clinical practice.

Keywords

• : CMV
• PCR
• ELISA
• IgM

Cytomegalovırus (CMV) Enfeksiyonu Tanısı İçin Gönderilen ELISA ve Real Time PCR Sonuçlarının Değerlendirilmesi

Abstract

AMAÇ: İnsan Cytomegalovirus (CMV), Herpesviridae ailesinin Betaherpesvirinae alt familyasına ait lineer çift iplikli, ikozahedral kapsidli zarflı bir virüstür. İmmünokompetan bireylerde nadiren patojenik olmasına rağmen, virüs immünokompromize bireyler için önemli bir sağlık tehdidi oluşturmaktadır. CMV enfeksiyonu ile hasta sağ kalımındaki azalma arasındaki anlamlı ilişki nedeniyle CMV enfeksiyonunun takip ve tedavisi çok önemlidir. Bağışıklık sistemi baskılanmış bireylerde akut CMV enfeksiyonunun teşhisi için serolojik test sonuçlarıyla hastaların değerlendirilmesinde önemli sınırlamalar bulunmaktadır; bu durumda viral nükleik asit tespiti en yaygın olarak polimeraz zincir reaksiyonu (PCR) ile CMV’ nin varlığı ortaya konabilir. Bu iki testin korelasyon düzeyi ile ilgili yapılan çok fazla sayıda çalışma yoktur; bu sebeple bu çalışmada CMV antikorlarının ve CMV DNA sonuçlarının karşılaştırmalı olarak değerlendirilmesini hedeflenmiştir. GEREÇ ve YÖNTEM: PCR aşamasında Bosphore CMV kantifikasyon kiti kullanılmıştır. CMV-IgM ve CMV-IgG antikor düzeyleri makro ELISA yöntemiyle (Cobas E 411/Roche) üretici tarafından açıklanan prosedüre göre çalışılmıştır. BULGULAR: Örneklerin %81 (298/367)’inde sonuçlar uyumludur; her iki test sonucu 280 (%76,2) örnekte negatif, 18 (%4,9) örnekte pozitif saptandı. IgM için negatif çıkan 302 hastanın %92,7'sinin CMV-PCR için de negatif olduğu ortaya konmuştur. 40 CMV-PCR pozitif hastanın yalnızca %45'i IgM testiyle pozitif olarak tanımlandı. İstatistiksel analiz, iki test arasında bu patojeni saptama oranları arasında anlamlı bir fark olduğunu göstermektedir (p<0,001). SONUÇ: Her iki testin negatif sonuçları arasında güçlü bir uyum vardır. Aynı uyum pozitif sonuçlar arasında gözlemlenememiştir. Genel olarak, klinik uygulamalarda CMV yönetim stratejilerini geliştirmek amacıyla daha geniş hasta gruplarıyla yapılacak ileri araştırmalar önerilmektedir.

Keywords

• CMV
• PCR
• ELISA
• IgM

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