Clinical validation of a novel diagnostic HIV-2 total nucleic acid qualitative assay using the Abbott m2000 platform: Implications for complementary HIV-2 nucleic acid testing for the CDC 4th generation HIV diagnostic testing algorithm

HIV-1 and HIV-2 diagnostic testing algorithms recommended by the Centers for Disease Control involve up to three tests and rely mostly on detection of viral antigen and host antibody responses. HIV-1 p24 antigen/HIV-1/2 antibody reactive specimens are confirmed with an immunochromatographic HIV-1/HIV-2 antibody differentiation assay and negative or indeterminate results from the differentiation assay are resolved by an HIV-1-specific nucleic acid amplification test (NAT). The performance of a proposed alternative algorithm using the cobas HIV-1/HIV-2 Qualitative NAT as the differentiation assay was evaluated in subjects known to be infected with HIV-1 (N=876) or HIV-2 (N=139), at low (N=6017) or high (N=1020) risk of HIV-1 infection, or at high-risk for HIV-2 infection (N=498) (Study A). The performance of the cobas HIV-1/HIV-2 Qualitative test was also evaluated by comparison to an HIV-1 or HIV-2 alternative NAT (Study B). The HIV-1 and HIV-2 overall percent agreements (OPA) in Study A ranged from 95%-100% in all groups. The positive percent agreements (PPA) for HIV-1 and HIV-2 were 100% (876/876) and 99.4% (167/168) respectively for known positive groups. The negative percent agreement in the HIV low-risk group was 100% for both HIV-1 and HIV-2. In Study B, the HIV-1 and HIV-2 OPA ranged from 99%-100% in all groups evaluated (N: 183 to 1030), and the PPA for HIV-1 and HIV-2 were 100% and 99.5% respectively for known positive groups. The cobas HIV-1/HIV-2 Qualitative Assay can discriminate between HIV-1 and HIV-2 based on HIV RNA, and can be included in an alternative diagnostic algorithm for HIV.

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Toward Uniform Nucleic Acid Testing Algorithm: Resolving Suspicious NAT Results for 3-Target Multiplexing Transcription-Mediated Amplification (TMA) Assay.

Transplantation Journal ◽

10.1097/00007890-201407151-00502 ◽

2014 ◽

Vol 98 ◽

pp. 165

Author(s):

C. Chinchilla-Reyes ◽

D. Tanglao ◽

M. Koss ◽

M. Nowicki

Keyword(s):

Nucleic Acid ◽

Nucleic Acid Testing ◽

Testing Algorithm

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Excluding Occult Hepatitis B Infection before Assigning False-Positive Status to Non-Repeatable NAT Reactivity: Concerning Stolz et al. “Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country” [Transfus Med Hemother. 2019 Apr;46(2):104–10]

Transfusion Medicine and Hemotherapy ◽

10.1159/000502552 ◽

2019 ◽

Vol 47 (3) ◽

pp. 272-274

Author(s):

Claire E. Styles ◽

Anthea Cheng ◽

Veronica C. Hoad ◽

Philip Kiely ◽

Michael Watson ◽

...

Keyword(s):

Nucleic Acid ◽

Hepatitis B ◽

False Positive ◽

Nucleic Acid Testing ◽

Years Of Experience ◽

Hepatitis B Infection ◽

Occult Hepatitis ◽

Occult Hepatitis B ◽

Testing Algorithm ◽

Low Prevalence

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Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country

Transfusion Medicine and Hemotherapy ◽

10.1159/000499166 ◽

2019 ◽

Vol 46 (2) ◽

pp. 104-110

Author(s):

Martin Stolz ◽

Peter Gowland ◽

Caroline Tinguely ◽

Christoph Niederhauser

Keyword(s):

Nucleic Acid ◽

Nucleic Acid Testing ◽

Years Of Experience ◽

Testing Algorithm ◽

Low Prevalence

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Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

Cell Reports Medicine ◽

10.1016/j.xcrm.2020.100062 ◽

2020 ◽

Vol 1 (5) ◽

pp. 100062 ◽

Cited By ~ 5

Author(s):

Dami A. Collier ◽

Sonny M. Assennato ◽

Ben Warne ◽

Nyarie Sithole ◽

Katherine Sharrocks ◽

...

Keyword(s):

Nucleic Acid ◽

Point Of Care ◽

Hospitalized Patients ◽

Clinical Validation ◽

Nucleic Acid Testing ◽

Implementation Study

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The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

Clinical Infectious Diseases ◽

10.1093/cid/ciab048 ◽

2021 ◽

Cited By ~ 1

Author(s):

Kimberly E Hanson ◽

Angela M Caliendo ◽

Cesar A Arias ◽

Mary K Hayden ◽

Janet A Englund ◽

...

Keyword(s):

Nucleic Acid ◽

Infectious Diseases ◽

Diagnostic Testing ◽

Molecular Diagnostic ◽

Evidence Based ◽

Solid Organ ◽

Care Hospital ◽

Nucleic Acid Testing ◽

Hematopoietic Stem ◽

Asymptomatic Individuals

Abstract Background Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance. Objective The IDSA’s goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space. Methods IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. Results The panel agreed on 17 diagnostic recommendations. Conclusions Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.

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Elevated white blood cell count does not predict Clostridium difficile nucleic acid testing results

Clinical Infectious Diseases ◽

10.1093/cid/ciab106 ◽

2021 ◽

Author(s):

Dustin E Bosch ◽

Patrick C Mathias ◽

Niklas Krumm ◽

Andrew Bryan ◽

Ferric C Fang ◽

...

Keyword(s):

Nucleic Acid ◽

Clostridium Difficile ◽

Blood Cell ◽

Cell Count ◽

Prognostic Marker ◽

White Blood Cell Count ◽

White Blood Cell ◽

Inpatient Setting ◽

Nucleic Acid Testing ◽

Blood Cell Count

Abstract Background An elevated white blood cell count (>15 thousand/μL) is an established prognostic marker in patients with Clostridium difficile infection (CDI). Small observational studies have suggested that a markedly elevated WBC should prompt consideration of CDI. However, there is limited evidence correlating WBC elevation with the results of C. difficile nucleic acid testing (NAAT). Methods Retrospective review of laboratory testing, outcomes, and treatment of 16,568 consecutive patients presenting to 4 hospitals over four years with NAAT and WBC testing on the same day. Results No significant relationship between C. difficile NAAT results and concurrent WBC in the inpatient setting was observed. Although an elevated WBC did predict NAAT results in the outpatient and emergency department populations (p<0.001), accuracy was poor, with receiver-operator areas under the curve of 0.59 and 0.56. An elevated WBC (>15 thousand/μL) in CDI was associated with a longer median hospital length of stay (15.5 vs. 11.0 days, p<0.01), consistent with leukocytosis as a prognostic marker in CDI. NAAT-positive inpatients with elevated WBC were more likely to be treated with metronidazole and/or vancomycin (relative ratio 1.2, 95% confidence interval 1.1–1.3) and die in the hospital (relative ratio 2.9, 95% CI 2.0–4.3). Conclusions Although WBC is an important prognostic indicator in patients with CDI, an isolated WBC elevation has low sensitivity and specificity as a predictor of fecal C. difficile NAAT positivity in the inpatient setting. A high or rising WBC in isolation is not a sufficient indication for CDI testing.

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