COVID-19 and Laboratory Medicine: Diagnosis, Monitoring, and Screening

This systematic review briefly discusses medical laboratory assays for the detection of the new coronavirus named as “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The most crucial tool to confine the spreading of coronavirus disease-2019 (COVID-19) is laboratory testing. The most commonly used laboratory assays are nucleic acid amplification tests (NAATs), antigen immunoassays, and antibody immunoassays or serological assays. The NAATs are considered “gold standard” assays for the diagnosis of the COVID-19. Among the NAATs, the most frequent one is reverse transcriptase real-time polymerase chain reaction (RT-PCR). Serology assays are also increasingly used. They have different forms; some detect total antibody response against COVID-19, some detect each antibody class individually as IgA, IgM, and IgG assays. They can be used as a laboratory assay or point of care assay. Currently, there are more than 10 companies manufacturing RT-PCR assay, and there are several companies manufacturing laboratory or point of care (POC) antibody assays. In this review pros and cons of laboratory assays were presented objectively and test utilization along with their analytical and clinical performances in the pandemic situation were discussed. There are significant variabilities between different products of different companies. When traditional validation and verification processes are implemented, all of those variabilities will be removed, and assay performances will be better.

Keywords: COVID-19, RT-PCR, immunoassay, test utilization

DOI :10.26650/BB/CH22.2020.008.04 IUP :10.26650/BB/CH22.2020.008.04 Full Text (PDF)

COVID-19 ve Laboratuvar Tıbbı: Tanı, İzlem ve Tarama

Doğan Yücel

Bu sistematik derleme, Şiddetli akut solunum sendromu koronavirus-2 (SARS-CoV-2) olarak da bilinen yeni koronavirüsün saptanmasında kullanılan tıbbi laboratuvar testlerini ele almaktadır. Koronavirüs-2019 (COVID-19) hastalığının yayılmasını sınırlandırmanın en önemli aracı laboratuvar testleridir. Bu amaçla en yaygın kullanılan laboratuvar testleri nükleik asit amplifikasyon testleri (NAAT) ile immünokimyasal antijen ve antikor testleri ya da seroloji testleridir. NAAT’ler içinde en sık kullanılanı gerçek zamanlı polimeraz zincir reaksiyonudur (RT-PCR). Seroloji testleri de giderek daha fazla kullanılmaktadır. Bunların farklı formları vardır, bazısı COVID-19’a karşı oluşan total antikor yanıtını saptarken, bazıları her bir antikor düzeyini IgM, IgA ve IgG şeklinde ayrı ayrı saptar ve otomatize olarak ya da hasta başı test şeklinde kullanılırlar. Günümüzde RT-PCR üreten 10’un üzerinde firma, laboratuvar testi ya da hasta başı test olarak antikor testi üreten çok sayıda firma vardır. Bu derlemede laboratuvar testlerinin artıları ve eksileri objektif olarak sunulmakta olup, bunun yanı sıra küresel salgın şartlarında testlerin analitik ve klinik performansları da tartışılmaktadır. Sonuç olarak, farklı firmaların ürünleri arasında önemli değişkenlikler vardır. Geleneksel validasyon ve verifikasyon süreçleri yürürlüğe konulduğunda tüm bu değişkenlikler ortadan kalkacak ve test performansları daha da gelişecektir.

Keywords: COVID-19, RT-PCR, immünokimyasal test, test kullanımı

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Covid-19: Molecular and Clinical Approach

CHAPTER

COVID-19 and Laboratory Medicine: Diagnosis, Monitoring, and Screening

COVID-19 ve Laboratuvar Tıbbı: Tanı, İzlem ve Tarama

References

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