P2-076: Performance evaluation of VIKIA® ANTI-HCV, rapid test for the qualitative detection of antibodies anti-HCV in European and non-European populations

KEY FINDINGS Current evidence does NOT support use of IgM/IgG rapid test kits for the definitive diagnosis of COVID-19 in currently symptomatic patients. • The present standard for diagnosis of COVID-19 is through qualitative detection of COVID-19 virus nucleic acid via reverse transcription polymerase chain reaction (RT-PCR). • Due to long turnaround times and complicated logistical operations, a rapid and simple field test alternative is needed to diagnose and screen patients. • An alternative to the direct detection and measurement of viral load (RT-PCR) is the qualitative detection of specific antibodies to COVID-19. ELISA (discussed in a separate rapid review) and lateral flow immunoassay (LFIA) IgM/IgG rapid test kits are two currently available, qualitative, antibody tests for COVID-19. • Two low quality clinical trials showed that there is insufficient evidence to support the use of IgM/IgG rapid test kits for the definitive diagnosis of COVID-19. Diagnostic accuracy varies greatly depending on the timing of the test. The test performed very poorly during the early phase of the disease (i.e., less than eight days from onset of symptoms). • Existing guidelines do not recommend serologic antibody tests for the diagnosis of COVID-19 in currently symptomatic patients.

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Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 test for bronchoalveolar lavage

10.1101/2021.12.21.21268190 ◽

2021 ◽

Author(s):

Tung Phan ◽

Ashley Mays ◽

Melissa McCullough ◽

Alan Wells

Keyword(s):

Bronchoalveolar Lavage ◽

Limit Of Detection ◽

Clinical Performance ◽

Rapid Test ◽

Rt Pcr ◽

Qualitative Detection ◽

Upper Respiratory ◽

Prompt Diagnosis ◽

Respiratory Specimens ◽

Rapid Laboratory

Accurate and rapid laboratory tests are essential for the prompt diagnosis of COVID-19, which is important to patients and infection control. The Xpert Xpress SARS-CoV-2 test is a real-time RT-PCR intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens. In this study, we assessed the analytical and clinical performance characteristics of this rapid test for SARS-CoV-2 in 60 bronchoalveolar lavage (BAL) specimens. BAL is a specimen type that is not authorized under EUA for the Xpert Xpress SARS-CoV-2 test. The limit of detection of the Xpert Xpress SARS-CoV-2 test was 500 copies/ml. The overall agreement of the Xpert Xpress SARS-CoV-2 test was 100%. The Xpert Xpress SARS-CoV-2 test is sensitive and specific to aid in diagnosis of COVID-19 using bronchoalveolar lavage.

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Faculty Opinions recommendation of New point of care Chlamydia Rapid Test--bridging the gap between diagnosis and treatment: performance evaluation study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1104740.560810 ◽

2008 ◽

Author(s):

Charlotte Gaydos

Keyword(s):

Performance Evaluation ◽

Point Of Care ◽

Rapid Test ◽

Evaluation Study ◽

Diagnosis And Treatment ◽

Treatment Performance

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SARS-CoV-2 immunochromatographic IgM/IgG rapid test in pregnancy: A false friend?

Annals of Clinical Biochemistry International Journal of Laboratory Medicine ◽

10.1177/0004563220980495 ◽

2020 ◽

pp. 000456322098049

Author(s):

M Fabre ◽

S Ruiz-Martinez ◽

ME Monserrat Cantera ◽

A Cortizo Garrido ◽

Z Beunza Fabra ◽

...

Keyword(s):

Positive Predictive Value ◽

Pregnant Women ◽

Predictive Value ◽

False Positive ◽

Screening Tool ◽

False Positive Rate ◽

Rapid Test ◽

Immunochromatographic Assay ◽

Qualitative Detection ◽

Positive Rate

Background An increasing body of evidence has revealed that SARS-CoV-2 infection in pregnant women could increase the risk of adverse maternal and fetal outcomes. Careful monitoring of pregnancies with COVID-19 and measures to prevent neonatal infection are warranted. Therefore, rapid antibody tests have been suggested as an efficient screening tool during pregnancy. Cases We analysed the clinical performance during pregnancy of a rapid, lateral-flow immunochromatographic assay for qualitative detection of SARS-CoV-2 IgG/IgM antibodies. We performed a universal screening including 169 patients during their last trimester of pregnancy. We present a series of 14 patients with positive SARS-CoV-2 immunochromatographic assay rapid test result. Immunochromatographic assay results were always confirmed by chemiluminescent microparticle immunoassays for quantitative detection of SARS-CoV-2 IgG and IgM+IgA antibodies as the gold standard. We observed a positive predictive value of 50% and a false positive rate of 50% in pregnant women, involving a significantly lower diagnostic performance than reported in non-pregnant patients. Discussion Our data suggest that although immunochromatographic assay rapid tests may be a fast and profitable screening tool for SARS-CoV-2 infection, they may have a high false positive rate and low positive predictive value in pregnant women. Therefore, immunochromatographic assay for qualitative detection of SARS-CoV-2 IgG/IgM antibodies must be verified by other test in pregnant patients.

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848 Performance evaluation of a rapid test for dust mite allergen detection in the home

Journal of Allergy and Clinical Immunology ◽

10.1016/s0091-6749(00)91276-4 ◽

2000 ◽

Vol 105 (1) ◽

pp. S289 ◽

Cited By ~ 8

Author(s):

S GUYTO

Keyword(s):

Performance Evaluation ◽

Rapid Test ◽

Mite Allergen ◽

Allergen Detection ◽

Dust Mite ◽

Dust Mite Allergen

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Cross-Reaction Antibody Test between SARS-CoV-2 and Dengue Hemorrhagic Fever in Indonesia

INDONESIAN JOURNAL OF CLINICAL PATHOLOGY AND MEDICAL LABORATORY ◽

10.24293/ijcpml.v27i2.1681 ◽

2021 ◽

Vol 27 (2) ◽

pp. 224

Author(s):

Danny Luhulima ◽

Tri Soetowo ◽

Ria Amelia

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Blood Test ◽

Rapid Test ◽

Antibody Test ◽

Hemorrhagic Fever ◽

Unknown Etiology ◽

Qualitative Detection ◽

Rapid Tests ◽

The Common ◽

Novel Coronavirus

Coronaviruses are a family of viruses that cause illness from the common cold to severe diseases such as Severe AcuteRespiratory Syndrome (SARS-CoV). In December 2019, forty new cases of pneumonia of unknown etiology have beenreported in Wuhan, China. The disease resembles Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) and hasbeen subsequently named the 2019-novel Coronavirus Disease (COVID-19). The antibody test is a blood test that providesquantitative and qualitative detection of IgG and IgM antibodies against the SARS-CoV-2. Reported a male, 43-year oldsuffering from DHF, but the results of an IgG and IgM rapid test were COVID-19 reactive. Also, reviewed rapid tests forCOVID-19 and the results showed that only IgG was reactive. This explained that the patient already had SARS Cov-2antibodies but was not suffering from the disease. The rapid test COVID-19 IgM result was deemed to be a false positive.

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