Detection of SARS-CoV-2 infection in the general population by three prevailing rapid antigen tests: cross-sectional diagnostic accuracy study

 Rapid antigen diagnostic tests (Ag-RDTs) are the most widely used point-of-care tests for detecting SARS-CoV-2 infection. Since the accuracy may have altered by changes in SARS-CoV-2 epidemiology, indications for testing, sampling and testing procedures, and roll-out of COVID-19 vaccination, we evaluated the performance of three prevailing SARS-CoV-2 Ag-RDTs.
 In this cross-sectional study, we consecutively enrolled individuals aged >16 years presenting for SARS-CoV-2 testing at three Dutch public health service COVID-19 test sites. In the first phase, participants underwent either BD-Veritor System (Becton Dickinson), PanBio (Abbott), or SD-Biosensor (Roche Diagnostics) testing with routine sampling procedures. In a subsequent phase, participants underwent SD-Biosensor testing with a less invasive sampling method (combined oropharyngeal-nasal [OP-N] swab). Diagnostic accuracies were assessed against molecular testing.
Six thousand nine hundred fifty-five of 7005 participants (99%) with results from both an Ag-RDT and a molecular reference test were analysed. SARS-CoV-2 prevalence and overall sensitivities were 13% (188/1441) and 69% (129/188, 95% CI 62-75) for BD-Veritor, 8% (173/2056) and 69% (119/173, 61-76) for PanBio, and 12% (215/1769) and 74% (160/215, 68-80) for SD-Biosensor with routine sampling and 10% (164/1689) and 75% (123/164, 68-81) for SD-Biosensor with OP-N sampling. In those symptomatic or asymptomatic at sampling, sensitivities were 72-83% and 54-56%, respectively.
Above a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities were 86% (125/146, 79-91) for BD-Veritor, 89% (108/121, 82-94) for PanBio, and 88% (160/182, 82-92) for SD-Biosensor with routine sampling and 84% (118/141, 77-89) with OP-N sampling. Specificities were >99% for all tests in most analyses. Sixty-one per cent of false-negative Ag-RDT participants returned for testing within 14 days (median: 3 days, interquartile range 3) of whom 90% tested positive.
Overall sensitivities of three SARS-CoV-2 Ag-RDTs were 69-75%, increasing to ≥86% above a viral load cut-off. The decreased sensitivity among asymptomatic participants and high positivity rate during follow-up in false-negative Ag-RDT participants emphasise the need for education of the public about the importance of re-testing after an initial negative INDICAID COVID test result Ag-RDT should symptoms develop. For SD-Biosensor, the diagnostic accuracy with OP-N and deep  nasopharyngeal sampling was similar; adopting the more convenient sampling method might reduce the threshold for professional testing.

Direct Detection of Feline Coronavirus by Three Rapid Antigen Immunochromatographic Tests and by Real-Time PCR in Cat Shelters

The aim of this study was the direct detection of feline coronavirus by real-time PCR and by three different rapid immunochromatographic (RIM) tests detecting antigens in faecal samples of shelter cats. Based on sensitivity and specificity calculated for each of the RIM tests, the utility of RIM tests was compared. Seventy faecal samples originating from shelter cats housed in quarantine were examined. Out of 70 samples analyzed by real-time PCR, 44 (62.9%) were positive. Significantly more cats (p < 0.05) tested positive than negative. Neither age nor sex of the cats played a significant role (p > 0.05) in the shedding status of the virus. The sensitivity of the RIM tests was found to be at low (<35%; RIM tests A and C) to satisfactory level (>50%, RIM test B). The number of virus particles determined by real-time RT-PCR analysis did not significantly correlate with the results detected by any of the RIM tests (p > 0.05). The results of this study indicate that the use of rapid antigen RIM tests in routine screening of FCoV shedding status in shelter cats is limited due to the occurrence of a high number of false negative results.

Impaired detection of omicron by SARS-CoV-2 rapid antigen tests

Since autumn 2020, rapid antigen tests (RATs) have been implemented in several countries as an important pillar of the national testing strategy to rapidly screen for infections on site during the SARS-CoV-2 pandemic. The current surge in infection rates around the globe is driven by the variant of concern (VoC) omicron (B.1.1.529).
Here, we evaluated the performance of nine SARS-CoV-2 RATs in a single-centre laboratory study. We examined a total of 115 SARS-CoV-2 PCR-negative and 166 SARS-CoV-2 PCR-positive respiratory swab samples (101 omicron, 65 delta (B.1.617.2)) collected from October 2021 until January 2022 as well as cell culture-expanded clinical isolates of both VoCs. In an assessment of the analytical sensitivity in clinical specimen, the 50% limit of detection (LoD50) ranged from 1.77 × 106 to 7.03 × 107 RNA copies subjected to the RAT for omicron compared to 1.32 × 105 to 2.05 × 106 for delta.
To score positive in these point-of-care tests, up to 10-fold (LoD50) or 101-fold (LoD95) higher virus loads were required for omicron- compared to delta-containing samples.
The rates of true positive test results for omicron samples in the highest virus load category (Ct values < 25) ranged between 31.4 and 77.8%, while they dropped to 0-8.3% for samples with intermediate Ct values (25-30). Of note, testing of expanded virus stocks suggested a comparable RAT sensitivity of both VoCs, questioning the predictive value of this type of in vitro-studies for clinical performance. Given their importance for national test strategies in the current omicron wave, awareness must be increased for the reduced detection rate of omicron infections by RATs and a short list of suitable RATs that fulfill the minimal requirements of performance should be rapidly disclosed.
INDICAID COVID-19 Antigen Rapid Test
INDICAID COVID-19 Antigen Rapid Test

Prevalence of Pfhrp2/3 gene deletions among false negative rapid antigen test results in central India

The diagnosis of Plasmodium falciparum malaria is widely dependent on the P. falciparum histidine rich protein 2 (PfHRP2) antigens based rapid diagnostic tests. There are few possible factors like Pfhrp2 polymorphism, Pfhrp2 deletion and density of malaria parasite which can affect the sensitivity of the Pf-HRP2-based RDT. The primary objective of the investigation was to check whether the Pfhrp2 gene deletion is the primary cause of RDT false negative cases.
 Febrile patients from three districts of Chhattisgarh, India were screened for malaria during 2016-2017 by microscopy and RDT. All microscopy P. falciparum positive samples were validated by PCR. Microscopy positive and RDT negative samples were analyzed for the presence of Exon 2, across Exon 1-2, upstream and downstream of both the Pfhrp2 and Pfhrp3 genes fragment by PCR.
 Out of 203 screened samples, 85 were detected positive for P. falciparum malaria based on microscopy and PCR. Among these 85 P. falciparum positive samples, 4 samples were observed Pf-HRP2 RDT negative. Although, it signified that the RDTs used were reliable with sensitivity of 95.3% (81/85). 3/4 PfHRP2-RDT negative samples of the P. falciparum isolates exhibited complete deletion of Pfhrp2 and Pfhrp3 genes and one sample was found RDT false negative due to high parasite density.
Pfhrp2 and Pfhrp3 deletions that result in false negative RDTs were uncommon in our setting. The continued monitoring of RDTS which results in false negative tests due to Pfhrp2/3 gene deletion is the need of the hour for an effective malaria elimination strategy.

Bean Extract-Based Gargle for Efficient Diagnosis of Active COVID-19 Infection Using Rapid Antigen Tests

The antigen-based rapid diagnostic test (Ag-RDT) using saliva specimens is fast, noninvasive, and suitable for SARS-CoV-2 self-testing, unlike nasopharyngeal swab (NPS) testing. We evaluated a novel Beanguard gargle (BG)-based virus collection method that can be applied to Ag-RDT as an alternative to the current RT-PCR with an NPS for early diagnosis of COVID-19.
This clinical trial comprised 102 COVID-19-positive patients hospitalized after a governmental screening process and 100 healthy individuals. Paired NPS and BG-based saliva specimens from COVID-19 patients and healthy individuals were analyzed using NPS-RT-PCR, BG-RT-PCR, and BG-Ag-RDTs, whose diagnostic performance for detecting SARS-CoV-2 was compared. BG-Ag-RDTs showed high sensitivity (97.8%) and specificity (100%) in 45 patients within 6 days of illness and detected all cases of SARS-CoV-2 Alpha and Delta variants.

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NOVATest Antigen Rapid Test Kit (For Single Use) (NOVA Test)

nCov-500-01 Atlas Link Technology 1T 162 EUR

Dengue Virus NS1 Antigen Rapid Test Kit

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Adenovirus Antigen and Rotavirus Antigen Rapid Test Kit

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Dog Giardia lamblia Antigen Rapid Test Kit

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Canine Distemper Virus Antigen Rapid Test Kit

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COVID-19 RT-qPCR Rapid Detection Kit

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Dengue Epi-10 Antigen For Rapid Test

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Monoclonal antibody for Covid 19 antigen test, conjugate (sensitivity 5ng/ml)

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Typhoid Antigen (S. typhi) Rapid Test Kit

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Typhoid Antigen (S. typhi) Rapid Test Kit

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Typhoid Antigen (S. typhi) Rapid Test Kit

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Malaria PF and PV Antigen Rapid Test Kit

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Malaria PF and PV Antigen Rapid Test Kit

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Malaria (Plasmodium Falciparum Antigen) Rapid Test Kit

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Malaria (Plasmodium Falciparum Antigen) Rapid Test Kit

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Malaria (Plasmodium Falciparum Antigen) Rapid Test Kit

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Prostate Specific Antigen (PSA) Rapid Test Kit

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Prostate Specific Antigen (PSA) Rapid Test Kit

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Canine distemper virus(CDV) antigen rapid test card

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Typhoid Antigen Rapid Test Kit(Colloidal Gold Method)

TRI-K15M1S TRI Biotech 50T 307.44 EUR

Typhoid Antigen Rapid Test Kit(Colloidal Gold Method)

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SARS-CoV-2 Rapid Antigen Test Nasal

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Respiratory Syncytial Virus (RSV) Antigen Rapid Test Kit

abx092218-100l Abbexa 100 µl 775 EUR

Respiratory Syncytial Virus (RSV) Antigen Rapid Test Kit

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Respiratory Syncytial Virus (RSV) Antigen Rapid Test Kit

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Canine Parvovirus Antigen (CPV Ag) Rapid Test Kit

HG001 EnoGene 10 Tests/Kit 16.1 EUR

Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit

abx092096-20tests Abbexa 20 tests 477.6 EUR

SARS-CoV-2 Spike Antigen Rapid Test (Uncut pad)

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Canine Coronavirus Antigen (CCV Ag) Rapid Test Kit

HG003 EnoGene 10 Tests/Kit 16.1 EUR

Feline Herpesvirus Antigen (FHV Ag) Rapid Test Kit

HG005 EnoGene 10 Tests/Kit 16.1 EUR

Feline Calicivirus Antigen (FCV Ag) Rapid Test Kit

HG030 EnoGene 10 Tests/Kit 21 EUR

Human Influenza A/B Virus Antigen Rapid Test Kit

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Human Influenza A/B Virus Antigen Rapid Test Kit

abx090713-1ml Abbexa 1 ml 10500 EUR

Human Influenza A/B Virus Antigen Rapid Test Kit

abx090713-200l Abbexa 200 µl 2100 EUR

Panbio COVID-19 AG RAPID T Device 25T NP

41FK10 Abbott 25 Tests/Kit 220 EUR

Panbio COVID-19 AG RAPID T DEVICE 25T NS

41FK11 Abbott 25 Tests/Kit 123.75 EUR

Feline Coronavirus Antigen (FCoV Ag) Rapid Test Kit

HG006 EnoGene 10 Tests/Kit 21 EUR

Human Monkeypox Virus Antigen (MPXV) Rapid Test Kit

abx092162-100l Abbexa 100 µl 1000 EUR

Human Monkeypox Virus Antigen (MPXV) Rapid Test Kit

abx092162-1ml Abbexa 1 ml 12000 EUR

Human Monkeypox Virus Antigen (MPXV) Rapid Test Kit

abx092162-200l Abbexa 200 µl 3500 EUR

Group A Streptococcus Antigen (GAS) Rapid Test Kit

abx092250-100l Abbexa 100 µl 2275 EUR

Group A Streptococcus Antigen (GAS) Rapid Test Kit

abx092250-1ml Abbexa 1 ml 30000 EUR

Group A Streptococcus Antigen (GAS) Rapid Test Kit

abx092250-200l Abbexa 200 µl 7800 EUR

Foot and Mouth Disease Virus Antigen Rapid Test Kit

abx092115-100l Abbexa 100 µl 487.5 EUR

Foot and Mouth Disease Virus Antigen Rapid Test Kit

abx092115-1ml Abbexa 1 ml Ask for price

Foot and Mouth Disease Virus Antigen Rapid Test Kit

abx092115-200l Abbexa 200 µl Ask for price

COVID-19 RNA Test, 1 test/pack

U20250 USTAR Biotechnologies (Hangzhou) test Ask for price

Helicobacter Pylori Antigen (H. Pylori) Rapid Test Kit

abx090728-100l Abbexa 100 µl 650 EUR

Helicobacter Pylori Antigen (H. Pylori) Rapid Test Kit

abx090728-1ml Abbexa 1 ml 7200 EUR

Helicobacter Pylori Antigen (H. Pylori) Rapid Test Kit

abx090728-200l Abbexa 200 µl 2100 EUR

Peste des petits ruminants(PPR) antigen rapid test card

LSY-20089-2 Shenzhen Lvshiyuan Biotechnology 40 test/kit Ask for price

African Swine Fever Virus(ASFV) Antigen Rapid Test Card

LSY-20113 Shenzhen Lvshiyuan Biotechnology 40 test/kit Ask for price

Peste des Petits Ruminants Virus Antigen Rapid Test Kit

abx092174-100l Abbexa 100 µl 437.5 EUR

Peste des Petits Ruminants Virus Antigen Rapid Test Kit

abx092174-1ml Abbexa 1 ml Ask for price

Peste des Petits Ruminants Virus Antigen Rapid Test Kit

abx092174-200l Abbexa 200 µl Ask for price

Dengue NS1 Antigen Rapid Test Kit(Colloidal Gold Method)

TRI-K10M1S TRI Biotech 50T 307.44 EUR

Dengue NS1 Antigen Rapid Test Kit(Colloidal Gold Method)

TRI-K10S1S TRI Biotech 25T 168.84 EUR

Classical Swine fever virus(CSFV) antigen rapid test card

LSY-20010 Shenzhen Lvshiyuan Biotechnology 40 test/kit Ask for price

SARS-CoV-2 Nucleocapsid Antigen Rapid Test (Uncut pad)

MBS355915-1Sheet MyBiosource 1Sheet 450 EUR

SARS-CoV-2 Nucleocapsid Antigen Rapid Test (Uncut pad)

MBS355915-5Sheets MyBiosource 5Sheets 1585 EUR

Porcine Transmissible Gastroenteritis Virus Antigen Rapid Test Kit

abx092131-100l Abbexa 100 µl 300 EUR

Porcine Transmissible Gastroenteritis Virus Antigen Rapid Test Kit

abx092131-1ml Abbexa 1 ml Ask for price

Porcine Transmissible Gastroenteritis Virus Antigen Rapid Test Kit

abx092131-200l Abbexa 200 µl Ask for price

Avian Influenza Virus Antigen Rapid Test Kit (Colloidal gold)

abx092015-40tests Abbexa 40 tests 518.4 EUR

Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva)

IOV87952 INVBIO 20T/kit 46.8 EUR

Porcine Epidemic Diarrhea (PED) virus antigen rapid test card

LSY-20109 Shenzhen Lvshiyuan Biotechnology 40 test/kit Ask for price

Canine Distemper Virus Antigen (CDV Ag) Rapid Test Kit

HG002 EnoGene 10 Tests/Kit 16.1 EUR

Canine Influenza virus Antigen (CIV Ag) Rapid Test Kit

HG028 EnoGene 10 Tests/Kit 16.1 EUR
In 11 asymptomatic active COVID-19 cases, both BG-Ag-RDTs and BG-RT-PCR showed sensitivities and specificities of 100%. Sensitivities of BG-Ag-RDT and BG-RT-PCR toward salivary viral detection were highly concordant, with no discrimination between symptomatic (97.0%), asymptomatic (100%), or SARS-CoV-2 variant (100%) cases. The intermolecular interactions between SARS-CoV-2 spike proteins and truncated canavalin, an active ingredient from the bean extract (BE), were observed in terms of physicochemical properties. The detachment of the SARS-CoV-2 receptor-binding domain from hACE2 increased as the BE concentration increased, allowing the release of the virus from hACE2 for early diagnosis. Using BG-based saliva specimens remarkably enhances the Ag-RDT diagnostic performance as an alternative to NPS and enables noninvasive, rapid, and accurate COVID-19 self-testing and mass screening, supporting efficient COVID-19 management.
 An Ag-RDT is less likely to be accepted as an initial test method for early diagnosis owing to its low sensitivity. However, our self-collection method, Ag-RDT using BG-based saliva specimens, showed significantly enhanced detection sensitivity and specificity toward SARS-CoV-2 including the Alpha and Delta variants in all patients tested within 6 days of illness. The method represents an attractive alternative to nasopharyngeal swabs for the early diagnosis of symptomatic and asymptomatic COVID-19 cases. The evidence suggests that the method could have a potential for mass screening and monitoring of COVID-19 cases.