Evaluation of the Abbott RealTime HBV DNA Assay and Comparison to the Cobas AmpliPrep/Cobas TaqMan 48 Assay in Monitoring Patients with Chronic. This study is aimed to investigate whether there is drug-resistant strains related detection difference between Abbott RealTime HBV (RealTime). Korean J Lab Med. Apr;28(2) doi: /kjlm [ Performance evaluation of Abbott RealTime HBV Quantification Kit for HBV viral.

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The performance was evaluated in terms of precision, linearity, detection sensitivity, cross-reactivity, and carry-over. Within-run and between-run coefficients of variation Rezltime were 3. None of hepatitis C virus showed cross-reactivity. No cross-contamination occurred when negative and positive samples were alternatively placed in a row. The performance of Abbott RealTime HBV Quantification kit was excellent; thus, it should be widely used in starting and monitoring of antiviral therapy in Korean patients with chronic hepatitis B.

Correlation and Bland-Altman plot analysis was used to compare the performance of the Abbott and Da-an assays. The correlation between the two assays was hvb by Pearson’s correlation and linear regression.

The Bland-Altman plots were used for the analysis of agreement between the two assays. Among the clinical serum samples, were quantifiable by both assays. Fifty-two samples were rsaltime by the Abbott assay but below the detection limit of the Da-an assay.

The Da-an assay presented lower sensitivity and a narrower linear range as compared to the Abbott assay, suggesting the need to be improved. Hepatitis B viral fealtime testing is essential to treatment and monitoring decisions in patients with chronic Hepatitis B.

Bland-Altman analysis showed average bias of Abbort was consistent across the assay range. Patient monitoring results using Veris demonstrated similar viral load trends over time to Cobas, RealTimeand artus. This negative bias should be taken into consideration if switching monitoring methods to Veris. Automated sample preparation systems must meet the demands of routine diagnostics laboratories with regard to performance characteristics and compatibility with downstream assays. The following performance characteristics were evaluated: Linearity was observed within the tested ranges for HIV Excellent precision was obtained inter-assay standard deviation for HIV No cross-contamination was observed, as well as no negative impact of elevated levels of various interfering substances.

Analytical and clinical evaluation of the Abbott RealTime hepatitis B sequencing assay. Long-term nucleoside analogue NA treatment leads to selection for drug-resistant mutations in patients undergoing hepatitis B virus HBV therapy. We evaluated the analytical performance of the Abbott assay and rwaltime its diagnostic performance to that of a laboratory-developed nested-PCR and sequencing method. To validate the clinical performances of the Abbott assay and the laboratory-developed assay, 89 clinical plasma samples with various levels of HBV DNA were tested using both assays.

Among 89 clinical specimens, 43 and 42 were amplification positive in the Abbott and laboratory-developed assays, respectively, with hb The Abbott assay failed to detect the minor mutant populations in two specimens, and therefore overall concordance was The Abbott assay showed comparable diagnostic performance to laboratory-developed nested PCR followed by direct sequencing, and may be useful as a routine method for detecting HBV NA resistance-associated mutations in clinical laboratory settings.

With several HBV DNA quantification assays available, it is important to use the most efficient testing system for virological monitoring. In this study, rezltime evaluated the performance characteristics and comparability of three HBV DNA quantification systems: No genotype-specific bias was seen in all three systems for HBV genotypes A, C, and D, which are predominant in this realttime.


This finding illustrates that the Abbott real-time HBV and artus-DSP systems show more comparable performance than the artus-DB system, meeting the current guidelines for assays to be used in the management of hepatitis B.

Performance characteristics and comparison of Abbott and artus real-time systems for hepatitis B virus DNA quantification. With an estimated million people worldwide chronically infected with hepatitis B virus HBVand the subsequent serious complications caused by liver damage including cirrhosis, liver failure, and hepatocellular carcinoma, HBV infection remains a global health issue, particularly in Taiwan, an HBV -hyperendemic area. Sensitive and accurate quantification of HBV DNA is necessary to monitor patients with chronic hepatitis B who are receiving antiviral therapy to determine treatment response and adapt therapy.

A total of 86 Currently available HBV DNA platforms and assays are generally designed for batching multiple specimens within an individual run and require at least one full day of work to complete the analyses.

The limit of detection of the assay was estimated to be 4. Intra-assay and interassay coefficients of variation ranged from 0.

Abbott RealTime HBV Assay

In conclusion, the Aptima HBV Quant assay is sensitive, specific, and reproducible and accurately quantifies HBV Reaktime in plasma samples from patients with chronic HBV infections of all genotypes, including patients on antiviral treatment with nucleoside or nucleotide analogues. Sensitive and accurate hepatitis B virus HBV DNA detection and quantification are essential to diagnose HBV infection, establish the prognosis of HBV -related liver disease, and guide the decision to treat and monitor the virological response to antiviral treatment and the emergence of resistance.

We collected paired swabs from female sex workers. The study was divided in two arms, according to the order of swab collection. If the Abbott swab was collected first, couples were concordant and two discordant Abbott negative and Copan positive. If the Copan swab was collected first, couples were concordant and 10 discordant eight Abbott negative and Copan positive and two Abbott positive and Copan negative.

All discordant samples contained low levels of C. Technical issues abott to retesting of 64 Copan and 21 Realtjme swabs.

Abbott RealTime HBV Assay

While appearing to have an advantage in detecting more positive samples, the use of Copan swabs led to a higher retesting rate due to technical errors. Consistency with restriction fragment mass polymorphism RFMP data, cross-reactivity with other viruses, and the ability to detect minor strains in mixtures of genotypes 1 and 2 were evaluated abbtot clinical samples.

No cross reactivity with other viruses was evident. Minor strains in the mixtures were not hvb distinguished, even at quantities higher than the detection limit.

Although the assay has the advantages of automation and short turnaround time, we suggest that further improvements are necessary before it is used routinely in clinical practice.

Efforts are needed to decrease cross reactivity among genotypes and to improve the ability to detect minor genotypes in mixed infections. The overall sensitivity and specificity of the Abbott assay were The detection rate of the Abbott assay was much higher among 37 acid-fast-positive specimens than among 23 acid-fast-negative specimens The detection rate of the assay was higher among 29 resection specimens than among 31 small biopsy specimens A total of 44, and 25, specimens were tested during periods 1 and 2, respectively.

A total of cervical swab specimens were obtained. The overall agreement rate was Discordant results between these two assays were observed realtie 25 cases. HC2 showed a sensitivity of Accuracy, linearity, interassay and intra-assay variations were determined, and a total of routine clinical samples were investigated.


Determination of linearity resulted in a quasilinear curve up to 1. The time to results was similar for both of the assays.

Congenital cytomegalovirus CMV infection is the leading cause of sensoneurinal disability due to infectious congenital disease. The diagnosis of congenital CMV infection is based on the search of CMV in the urine within the first two weeks of life. Viral culture of urine is the gold standard. However, the PCR is highly sensitive and faster. It is becoming an alternative choice. Repeatability, reproducibility, detection limit and inter-sample contamination were evaluated.

The sensitivity and specificity of PCR were also calculated. Fidelity is very good standard deviation of repeatability: This prospective study evaluated the diagnostic performance of this new platform for MTBC and multidrug-resistant tuberculosis MDR-TB using sputum specimens in a tuberculosis high-burden setting.

Using conventional culture results and clinical background as reference standards, Abbott -RT exhibited an overall sensitivity and specificity of Two of the RIF-resistant specimens carried a novel single, nonsense mutation at rpoB Q and in silico simulation demonstrated that the truncated RpoB protein failed to bind with other subunits for transcription.

Real-Time Hepatitis B Virus Assay

The study population consisted of women who were included in three referral gynecology clinics in Marseilles France between March and June The automation and ability to identify type 16 and 18 make this a very attractive option for HPV testing in laboratories and potentially provides improved patient management. Published by Elsevier B. Performance of the new automated Abbott RealTime MTB assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens.

This study would like to evaluate its performance. Prospective analysis of a total specimens was then hvv to further evaluate the Abbott assay.

The Abbott assay zbbott a lower limit of detection at The Abbott assay demonstrated extremely low PCR inhibition on clinical respiratory specimens.

The automated Abbott assay required only very short manual handling time 0. No cross-reactivity with non-tuberculosis mycobacterial species was observed.

The specimens were collected from a total of 3, wbbott and female subjects at 16 geographically diverse sites.

Specimens included male and female urine samples, male urethral swabs, female endocervical swabs, and self-collected and clinician-collected vaginal swabs. For each subject, a patient infected status PIS was determined based on the combined results from the reference assays. The overall prevalence in female subjects was 8.

The overall male prevalence was In comparison, the sensitivity and specificity, respectively, for the Aptima Combo 2 assay were The automated assay provides a useful alternative nucleic acid amplification assay for clinical laboratories and clinicians. Clinical evaluation of the Abbott RealTime MTB Assay for direct detection of Mycobacterium tuberculosis-complex from respiratory and non-respiratory samples.

Rapid and reliable diagnosis is crucial for correct management of tuberculosis. We evaluated this commercial diagnostic test by analyzing respiratory and, for the first time, 87 non-respiratory clinical specimens from our tertiary care institution and compared its results to our ISbased in-house real-time PCR for MTB as well as MTB culture. We document successful analysis of 87 non-respiratory samples with the highly automated Abbott RealTime MTB test with no inhibition observed.

Correlation and bias values were obtained. With clinical samples, the correlation coefficient r value was 0. The results demonstrated that the Abbott RealTime HIV-1 assay with DBS sample protocol is highly sensitive, specific and precise across a wide dynamic range and correlates well with plasma values.