Should IgM/IgG rapid test kit be used in the diagnosis of COVID-19?

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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Screening, Diagnostic and Prognostic Tests for COVID-19: A Comprehensive Review

Life ◽

10.3390/life11060561 ◽

2021 ◽

Vol 11 (6) ◽

pp. 561

Author(s):

Mariana Ulinici ◽

Serghei Covantev ◽

James Wingfield-Digby ◽

Apostolos Beloukas ◽

Alexander G. Mathioudakis ◽

...

Keyword(s):

Point Of Care ◽

Standard Test ◽

Current Evidence ◽

Molecular Testing ◽

Rt Pcr ◽

Diagnostic Screening ◽

Comprehensive Review ◽

Prognostic Tests ◽

Polymerase Chain ◽

Antigen Testing

While molecular testing with real-time polymerase chain reaction (RT-PCR) remains the gold-standard test for COVID-19 diagnosis and screening, more rapid or affordable molecular and antigen testing options have been developed. More affordable, point-of-care antigen testing, despite being less sensitive compared to molecular assays, might be preferable for wider screening initiatives. Simple laboratory, imaging and clinical parameters could facilitate prognostication and triage. This comprehensive review summarises current evidence on the diagnostic, screening and prognostic tests for COVID-19.

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Avian influenza and Newcastle disease virusindead chickens in markets in Dhaka, Bangladesh in 2011-2012

Bangladesh Veterinarian ◽

10.3329/bvet.v33i1.33308 ◽

2017 ◽

Vol 33 (1) ◽

pp. 8-15

Author(s):

LR Barman ◽

RD Sarker ◽

BC Das ◽

EH Chowdhury ◽

PM Das ◽

...

Keyword(s):

Influenza Virus ◽

Avian Influenza ◽

Newcastle Disease ◽

Rapid Test ◽

Type A ◽

Antigen Test ◽

Rt Pcr ◽

Test Kit ◽

Live Bird

A virological survey for avian influenza (AI) and Newcastle disease (ND) was conducted in two selected live bird markets (LBMs), namely Kaptan Bazar and Karwan Bazar in Dhaka city, Bangladesh from August 2011 to July 2012. A total of 513 dead chickens were collected. An immune-chromatographic rapid antigen test for Type A influenza virus and both conventional and real time RT-PCR were used for the detection and characterization of AI and ND viruses. All carcasses were first screened by the rapid antigen test kit and 93 were positive for Type A influenza virus. RT-PCR on a representative number of rapid antigen test positive samples (n = 24) confirmed the presence of Type A influenza virus and mostly H5 influenza virus (22 out of 24 tested samples). Influenza rapid test negative samples (n = 420) were subjected to routine necropsy. Heat stress, suffocation and physical injury were the most common cause of mortality (163 cases), followed by ND, suspected to be the cause of 85 deaths. On molecular investigation of these 85 samples, the presence of ND virus was confirmed in 59 and AI virus in 6; 15 were negative for both ND and AI viruses and 5 were unsuitable for investigation. Among the 59 ND confirmed cases 18 also contained AI virus. In summary, out of 513 carcasses 117 (22.81%) contained AI virus and 59 (11.50%) contained ND virus. Eighteen (3.51%) carcasses contained both AI and ND viruses. The findings suggest that both AI and ND should be considered as major threats to the poultry industry.Bangl. vet. 2016. Vol. 33, No. 1, 8-15

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Diagnostic Properties of Three SARS-CoV-2 Antibody Tests

Diagnostics ◽

10.3390/diagnostics11081441 ◽

2021 ◽

Vol 11 (8) ◽

pp. 1441

Author(s):

Suelen Basgalupp ◽

Giovana dos Santos ◽

Marina Bessel ◽

Lara Garcia ◽

Ana Carolina de Moura ◽

...

Keyword(s):

Rapid Test ◽

Epidemiological Studies ◽

Antibody Detection ◽

Sample Collection ◽

Rt Pcr ◽

Igg Antibody ◽

Serological Tests ◽

High Agreement ◽

High Level ◽

Antibody Tests

Serological assays emerged as complementary tools to RT-PCR in the diagnosis of SARS-CoV-2 as well as being needed for epidemiological studies. This study aimed to assess the performance of a rapid test (RT) compared to that of serological tests using finger prick blood samples. A total of 183 samples were evaluated, 88 of which were collected from individuals with negative RT-PCR and 95 from positive RT-PCR individuals. The diagnostic performance of RT (WONDFO®) and LUMIT (PROMEGA®) were compared to that of ELISA (EUROIMMUN®) for detecting antibodies against SARS-CoV-2 according to time from symptoms onset. The IgG antibody tests were detected in 77.4% (LUMIT), 77.9% (RT), and 80.0% (ELISA) of individuals. The detection of antibodies against SARS-CoV-2 increases in accordance with increasing time from symptoms onset. Considering only time from symptoms onset >21 days, the positivity rate ranged from 81.8 to 97.0% between the three tests. The RT and LUMIT showed high agreement with ELISA (agreement = 91.5%, k = 0.83, and agreement = 96.3%, k = 0.9, respectively) in individuals who had symptoms 15 to 21 days before sample collection. Compared to that of the ELISA assay, our results show sensitivity ranged from 95% to 100% for IgG antibody detection in individuals with symptoms onset between 15 and 21 days before sample collection. The specificity was 100% in individuals with symptoms onset >15 days before serological tests. This study shows good performance and high level of agreement of three immunoassays for the detection of SARS-CoV-2 antibodies.

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Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar

Journal of Public Health Research ◽

10.4081/jphr.2021.2421 ◽

2021 ◽

Author(s):

Jesha Mundodan ◽

Samina Hasnain ◽

Hayat Khogali ◽

Soha Shawqi Al Bayat ◽

Dina Ali ◽

...

Keyword(s):

Predictive Value ◽

Local Population ◽

Rapid Test ◽

Antibody Test ◽

Molecular Testing ◽

Rt Pcr ◽

Test Kit ◽

Asymptomatic Individuals ◽

Sensitivity Specificity ◽

Rapid Antibody

Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting.Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar. Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated.Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%.Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation.

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Real Time-Polymerase Chain Reaction (RT-PCR) and Antibody Tests

Covid-19 ◽

10.1201/9781003131410-3 ◽

2021 ◽

pp. 111-164

Author(s):

Parag Verma ◽

Ankur Dumka ◽

Alaknanda Ashok ◽

Amit Dumka ◽

Anuj Bhardwaj

Keyword(s):

Polymerase Chain Reaction ◽

Real Time ◽

Rt Pcr ◽

Chain Reaction ◽

Polymerase Chain ◽

Antibody Tests

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Potential Use of Antigen-Based Rapid Test for SARS-CoV-2 in Respiratory Specimens in Low-Resource Settings in Egypt for Symptomatic Patients and High-Risk Contacts

Laboratory Medicine ◽

10.1093/labmed/lmaa104 ◽

2020 ◽

Author(s):

Abeer Mohamed Abdelrazik ◽

Shahira Morsy Elshafie ◽

Hossam M Abdelaziz

Keyword(s):

Test Performance ◽

Healthcare Professionals ◽

Rapid Test ◽

University Hospital ◽

Antigen Test ◽

Rt Pcr ◽

Viral Loads ◽

Viral Transport Medium ◽

Public Health Challenges ◽

Polymerase Chain

Abstract Objective Because of the rapidly emerging SARS-CoV-2 pandemic and its wide public health challenges, rapid diagnosis is essential to decrease the spread. Antigen-based rapid detection tests are available; however, insufficient data about their performance are available. Methods The lateral-flow immunochromatographic BIOCREDIT COVID-19 antigen test was evaluated using nasopharyngeal swabs in a viral transport medium from patients with confirmed infection, contacts, and exposed healthcare professionals at Fayoum University Hospital in Egypt. Test performance was determined in comparison to the SARS-CoV-2 real-time reverse-transcription polymerase chain reaction (RT-PCR) test. Results Three hundred ten specimens from 3 categories—patients with confirmed diagnoses of COVID-19, contacts, and exposed healthcare professionals—were included; 188 specimens were RT-PCR-positive, from which 81 were detected by rapid antigen test. Overall sensitivity was 43.1%. Sensitivity was significantly higher in specimens with high viral loads. Conclusion Poor sensitivity of the BIOCREDIT COVID-19 test does not permit its use for diagnosis, and it can only be used in conjunction with RT-PCR for screening.

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Development of rapid immunochromatographic strip test for the detection of porcine epidemic diarrhoea virus

Veterinary Record ◽

10.1136/vr.103959 ◽

2017 ◽

Vol 181 (22) ◽

pp. 596-601 ◽

Cited By ~ 7

Author(s):

Kwang-Soo Lyoo ◽

Minjoo Yeom ◽

Jungho Kim ◽

Donghyuk Kim ◽

Gunwoo Ha ◽

...

Keyword(s):

Real Time ◽

Rapid Test ◽

Epidemiological Surveillance ◽

Watery Diarrhoea ◽

Rt Pcr ◽

Immunochromatographic Strip ◽

Test Kit ◽

Porcine Epidemic Diarrhoea Virus ◽

Diarrhoea Virus ◽

Strip Test

Porcine epidemic diarrhoea virus (PEDV) causes acute and severe watery diarrhoea and dehydration, as well as 50–100 per cent mortality in piglets. For the PEDV diagnosis, a rapid test kit that is specific and sensitive to PEDV is critical to monitor this disease at pig farms. The present study aimed to develop an immunochromatographic assay (ICA) strip test for detecting PEDV in faecal swabs. The newly developed diagnostic test showed a detection limit of 104.0TCID50/ml of PEDV. Using faecal swab samples, the relative sensitivity and specificity of the ICA kit were 95.0 per cent and 98.6 per cent, respectively, compared with those of real-time RT-PCR. In samples from piglets experimentally infected with PEDV, the results showed 100 per cent agreement with those found by real-time RT-PCR. Our developed test strip will be useful for rapid diagnosis and can be used for epidemiological surveillance of PEDV infection.

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Direct detection of the porcine reproductive and respiratory syndrome (PRRS) virus by reverse polymerase chain reaction (RT-PCR)

Archives of Virology ◽

10.1007/bf01309767 ◽

1994 ◽

Vol 135 (1-2) ◽

pp. 89-99 ◽

Cited By ~ 55

Author(s):

P. Su�rez ◽

R. Zardoya ◽

C. Prieto ◽

A. Solana ◽

E. Tabar�s ◽

...

Keyword(s):

Polymerase Chain Reaction ◽

Direct Detection ◽

Rt Pcr ◽

Chain Reaction ◽

Prrs Virus ◽

Polymerase Chain

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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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ANTI-HIV DAN SUBTIPE HIV PADA PASIEN HEMODIALISIS

INDONESIAN JOURNAL OF CLINICAL PATHOLOGY AND MEDICAL LABORATORY ◽

10.24293/ijcpml.v22i2.1124 ◽

2018 ◽

Vol 22 (2) ◽

pp. 182

Author(s):

Retno Handajani ◽

Mochammad Thaha ◽

Mochamad Amin ◽

Citrawati Dyah Kencono Wungu ◽

Edhi Rianto ◽

...

Keyword(s):

Rapid Test ◽

Rt Pcr ◽

Hiv Rna ◽

Hemodialysis Unit ◽

Test Kit ◽

Ckd Stage ◽

Immunodeficiency Virus ◽

Low Levels ◽

Anti Hiv ◽

Hiv 1

Anti-Human Immunodeficiency Virus (Anti-HIV) was performed from 100 plasma Chronic Kidney Disease (CKD) stage 5 patientswith continuous hemodialysis (HD) at the Hemodialysis Instalation Dr Soetomo hospital, Surabaya, Indonesia, using three (3) kind ofreagents: Tri-line HIV Rapid test Device from Acon for HIV 1/2/O as strips form, Foresight HIV 1/2/O Antibody EIA Test Kit from Aconand Anti-HIV 1+2/Subtype O ELISA from Axiom. HIV RNA and HIV subtype were detected by Reverse Transcription Polymerase ChainReaction (RT-PCR) based on HIV gag region and analysis of DNA result. Seventy three % patients were hemodialysed twice in a week andonly 14% with duration more than five (5) years. Most of the patients (43%) were hemodialysed between 100−300 times. From the 100plasma samples was obtained only one (1%) man patient plasma sample with positive anti-HIV. A weak positive of RT-PCR result wasnot succeed to be sequenced for determining the HIV subtype. This cause was suspected due to low levels of HIV RNA in blood. The resultsof this study was expected can be used as an additional management consideration of hemodialysis patients at the Hemodialysis Unit.

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