Evidence map›Paper›PMID 36592297›Full record

ArticleInfection2023

The evaluation results of proposed antigen rapid diagnostic tests for COVID-19: some possible factors might influence.

Juniastuti, Abdul Hadi Furqoni, Mochamad Amin, Yanna Debby Restifan, Serius Miliyani Dwi Putri, Virginia Ayu Ferandra, Maria Inge Lusida

Abstract read
In one paragraph

Article in Infection, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Laboratory Evaluation of a SARS-CoV-2 RT-LAMP Test.Tropical medicine and infectious disease · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

JuniastutiDepartment of Medical Microbiology, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, Indonesia.ORCID http://orcid.org/0000-0002-1437-640X
Abdul Hadi FurqoniInstitute of Tropical Disease, Universitas Airlangga, Campus C Jalan Mulyorejo, Surabaya, East Java, Indonesia.ORCID http://orcid.org/0000-0002-3958-5881
Mochamad AminInstitute of Tropical Disease, Universitas Airlangga, Campus C Jalan Mulyorejo, Surabaya, East Java, Indonesia.ORCID http://orcid.org/0000-0001-7005-5267
Yanna Debby RestifanInstitute of Tropical Disease, Universitas Airlangga, Campus C Jalan Mulyorejo, Surabaya, East Java, Indonesia.ORCID http://orcid.org/0000-0002-8093-3956
Serius Miliyani Dwi PutriInstitute of Tropical Disease, Universitas Airlangga, Campus C Jalan Mulyorejo, Surabaya, East Java, Indonesia.ORCID http://orcid.org/0000-0003-2071-4046
Virginia Ayu FerandraInstitute of Tropical Disease, Universitas Airlangga, Campus C Jalan Mulyorejo, Surabaya, East Java, Indonesia.
Maria Inge LusidaDepartment of Medical Microbiology, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, Indonesia. ingelusida@itd.unair.ac.id.

Funding

National Research and Innovation Agency - Ministry of Research and Technology of the Republic of Indonesia the decree of the main director of the educational fund management institution No. 29/LPDP/2020
6 · The paper itself

Abstract

purposeIn addition to existing gold standard qRT-PCR methods, there is a need to develop reliable rapid tests for infection control with early notification of COVID-19 cases to enable effective outbreak management. We evaluated the validity of the three Ag-RDT kits proposed by some companies in different countries by using qRT-PCR and analyzed its results.

methodsEach of the three Ag-RDT kits (namely A, B, and C) was tested with 90 samples, consisting of samples with Ct ≤ 25, samples with Ct > 25, and negative SARS-CoV-2 PCR samples.

resultsThis study showed that for samples with Ct > 25, all the three kits could not detect SARS-CoV-2 Ag (0% sensitivity) but showed 100% specificity. Meanwhile, for samples with Ct ≤ 25, kit C was the best (76.7% sensitivity and 100% specificity). The PPV of the three kits was 100%, but their NPV ranged 63-84.8%. Kit C showed the best accuracy (89.9%). Some factors might influence the results of evaluation, such as variation of virus proteins and transportation-storage of the kits.

conclusionThe overall specificity of the three kits for all samples was high; however, all of them have not met the minimum performance requirements of ≥ 80% sensitivity for samples with Ct ≤ 25. The validation test is much necessary to be carried out by the authority in national health care to ensure the feasibility of the kit for point-of-care testing (POCT) of COVID-19. Some factors that might influence should be anticipated to increase their sensitivities and specificities.

Indexed as

COVID-19COVID-19 TestingDisease OutbreaksHumansPoint-of-Care TestingRapid Diagnostic TestsSARS-CoV-2Sensitivity and SpecificityCOVID-19Rapid antigen detection testSARS-CoV-2

Identifiers

PMID36592297
PMCPMC9806449

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.