| Abstrakt: |
Background: As previously reported, the measurement of ethanol can also be affected by interference from hemolysis. This is a matter of concern since ethanol is widely regarded as the most commonly abused substance globally. When sample re-collection is ordered to eliminate hemolysis effects for ethanol testing, this can have unfavourable consequences for these patients. Rapid detection of hemolysed specimens would alleviate some issues associated with forensic samples. This study aimed to assess the qualitative analytical performance of a novel point-of-care testing device per the guidelines specified in CLSI-EP-12A document. HemCheck™ is a novel POCT device that qualitatively detects free-hemoglobin levels on the specimen shortly after drawing the sample. Methods: The system consists of two components. One is a cartridge with a needle that is used to transfer a small volume of whole blood from a vacuum tube to vertical and lateral flow filtration. The second component is the reader. The consumable cartridges are designed to be inserted into the reader without requiring the syringe or blood collection tube removal. A red indicator led illuminates, indicating that the sample has been hemolysed. To assess the imprecision of the method, we determined the C5-C95 interval and C50, using the Roche Cobas clinical chemistry analyser as the comparator. For this study, we utilised residual samples. Results: Our C50 concentrations were 45 mg/dL, the C5- C95 30 mg/dL and 60 mg/dL, respectively. Two methods reveal an overall agreement of 89.2%. The diagnostic sensitivity and specificity of the study showed a positive agreement of 95.7% and a negative agreement of 80. C%. The calculated Cohen's Kappa value was 77.3%. Conclusionn: According to current literature, a bias in ethanol levels can be noticed even with small free hemoglobin concentrations. When it came to forensic samples, this bias was crucial. Our study confirmed that the HemCheck devce has acceptable analytical performance, as outlined in the CLSI-EP-12A document. Although the possible beneficial impacts of the innovative POCT hemolysis detection device on the preanalytical phase are proposed, we have not studied them in this study. Uvod: Kao što je ranije objavljeno, na merenje etanola može uticati i interferencija hemolize. Ovo je zabrinjavajuće jer se etanol smatra supstancom koja se najčešće zloupotrebljava u svetu. Kada se naloži ponovno uzimanje uzorka da bi se eliminisali efekti hemolize na testiranje etanola, to može imati nepovoljne posledice za pacijente. Brzo otkrivanje hemolizovanih uzoraka bi dalo odgovore na neke probleme povezane sa forenzičkim uzorcima. Ova studija je imala za cilj da proceni kvalitativne analitičke performanse novog uređaja za testiranje na licu mesta, u skladu sa smernicama navedenim u dokumentu CLSI-EP- 12A. HemCheck'" je novi POCT uređaj koji kvalitativno detektuje nivoe slobodnog hemoglobina na uzorku ubrzo nakon uzorkovanja. Metode: Sistem se sastoji od dve komponente. Jedan je kertridž sa iglom koji se koristi za prenošenje male zapre- mine pune krvi iz vakuumske cevi do filtracije vertikalnog i bočnog protoka. Druga komponenta je čitač. Potrošni ker- tridži su dizajnirani da se umetnu u čitač bez potrebe za uklanjanjem šprica ili epruvete za prikupljanje krvi. Crvena indikatorska lampica svetli, što ukazuje da je uzorak hemo- lizovan. Da bismo proceniii nepreciznost metode, odredili smo interval C5-C95 i C50, koristeći klinički Roche Cobas analizator kao komparator. U ovoj studiji smo koristili rezidualne uzorke. Rezultati: Naše koncentracije C50 su bile 45 mg/dL, C5- C95 30 mg/dL i 60 mg/dL, respektivno. Dve metode otkrivaju ukupno slaganje od 89,2%. Dijagnostička osetljivost i specifičnost studije pokazala je pozitivno slaganje od95,7% i negativno slaganje cd 80,0%. Izračunata Koenova Kapa vrednost je bila 77,3%. ZeWjL>5aL FYema trenutnoj literaturi, pristrasrost nivoa etanola se može primetiti čak i sa malim koncentracijama slobodnog hemoglobina. Kada su u pitanju forenzički uzorci, ova pri st rasno st je bila ključna. Naša studija je potvrdila da HemCheck uređaj ima prihvatljive analitičke performanse, kao što je navedeno u dokumentu CLSI-EP-12A. lako su predloženi mogući korisni uticaji inovativnog POCT uređaja za detekciju hemolize na preanalitičku fazu, mi ih nismo proučavali u ovoj studiji. [ABSTRACT FROM AUTHOR] |
