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

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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  INDICAID Antigen Test  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.

Isolation is recommended during acute infection with SARS-CoV-2, the virus that causes COVID-19, but the duration of infectiousness varies among individual persons.

  • Rapid antigen test results have been correlated with detection of viable virus (1-3) and might inform isolation guidance, but data are limited for the recently emerged SARS-CoV-2 B.1.1.529 (Omicron) variant.
  • On January 5, 2022, the Yukon-Kuskokwim Health Corporation (YKHC) recommended that persons with SARS-CoV-2 infection isolate for 10 days after symptom onset (or, for asymptomatic persons, 10 days after a positive nucleic acid amplification or antigen test result). However, isolation could end after 5-9 days if symptoms were resolving or absent, fever was absent for ≥24 hours without fever-reducing medications, and an Abbott BinaxNOW COVID-19 Ag (BinaxNOW) rapid antigen test result was negative.
  • Antigen test results and associated individual characteristics were analyzed among 3,502 infections reported to YKHC during January 1-February 9, 2022. After 5-9 days, 396 of 729 persons evaluated (54.3%) had a positive antigen test result, with a declining percentage positive over time.
  • In a multivariable model, a positive antigen test result was more likely after 5 days compared with 9 days (adjusted odds ratio [aOR] = 6.39) or after symptomatic infection (aOR = 9.63), and less likely after previous infection (aOR = 0.30), receipt of a primary COVID-19 vaccination series (aOR = 0.60), or after both previous infection and receipt of a primary COVID-19 vaccination series (aOR = 0.17).
  • Antigen tests might be a useful tool to guide recommendations for isolation after SARS-CoV-2 infection. During the 10 days after infection, persons might be infectious to others and are recommended to wear a well-fitting mask when around others, even if ending isolation after 5 days.

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.

China’s NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents

 

  1. The COVID-19 pandemic continues to spread all over the world. In the process of emergency use authorization, the Center for Medical Device Evaluation of the China National Medical Products Administration issued ‘Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents’ as the guidance of registration of antigen and antibody test reagents for the industry.
  2. In this document, clinical evaluation requirements of antigen detection reagents are elaborated. Based on the Key Points document and the authors’ review practice, this article explains the evaluation methods and requirements of clinical performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests, then analyzes the application scenarios and intended use of antigen detection reagents.
  3. 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.
  4. 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.
  5. This clinical trial comprised 102 COVID-19-positive patients hospitalized after a governmental screening process and 100 healthy individuals.
  6. 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. 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.

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P005-RPE-125 Biotium 1UL 172 EUR

ExoBrite™ 680/700 CD9 Western Antibody (25 tests)

P003-680-250 Biotium 1UL 204 EUR

ExoBrite™ 770/800 CD9 Western Antibody (25 tests)

P003-770-250 Biotium 1UL 204 EUR

Dual Sensor Casp 3/7 &MMP 25 Tests

MITCAP200-1 Cell Technology 25 Tests 182.5 EUR

ExoBrite™ 680/700 CD63 Western Antibody (25 tests)

P004-680-250 Biotium 1UL 204 EUR

ExoBrite™ 770/800 CD63 Western Antibody (25 tests)

P004-770-250 Biotium 1UL 204 EUR

ExoBrite™ 680/700 CD81 Western Antibody (25 tests)

P006-680-250 Biotium 1UL 204 EUR

ExoBrite™ 770/800 CD81 Western Antibody (25 tests)

P006-770-250 Biotium 1UL 204 EUR

Casp 3/7 FAM-DEVD-FMK 25 Tests

FAM200-1 Cell Technology 25 Tests 205 EUR

Monkey Anti-ANA (Anti-nuclear Antigens/ENA) IgG ELISA Kit, 96 tests, Quantitative

670-110-ANM Alpha Diagnostics 1 Kit 927.6 EUR

Monkey Anti-ANA (Anti-nuclear Antigens/ENA) IgM ELISA Kit, 96 tests, Quantitative

670-115-ANM Alpha Diagnostics 1 Kit 927.6 EUR

ExoBrite™ 770/800 Calnexin Western Antibody (25 tests)

P007-770-250 Biotium 1UL 204 EUR

Nori® Human CRP POCT Systems-25 Tests

GR220008 Genorise Scientific 25 Tests 299 EUR

Nori® Human ANP POCT Systems-25 Tests

GR220010 Genorise Scientific 25 Tests 618 EUR

Nori® Human ST2 POCT Systems-25 Tests

GR220016 Genorise Scientific 25 Tests 618 EUR

Iron Alum 250ml Indicator Dairy Testing - EACH

DAI1136 Scientific Laboratory Supplies EACH 176.85 EUR

Nori® Human GPBB POCT Systems-25 Tests

GR220009 Genorise Scientific 25 Tests 618 EUR

Nori® Human MMP2 POCT Systems-25 Tests

GR220017 Genorise Scientific 25 Tests 618 EUR

Nori® Canine CRP POCT Systems-25 Tests

GR221008 Genorise Scientific 25 Tests 299 EUR

Nori® Canine ANP POCT Systems-25 Tests

GR221010 Genorise Scientific 25 Tests 618 EUR

Nori® Canine ST2 POCT Systems-25 Tests

GR221016 Genorise Scientific 25 Tests 618 EUR

Nori® Feline CRP POCT Systems-25 Tests

GR222008 Genorise Scientific 25 Tests 299 EUR

Nori® Feline ANP POCT Systems-25 Tests

GR222010 Genorise Scientific 25 Tests 618 EUR

Nori® Feline ST2 POCT Systems-25 Tests

GR222016 Genorise Scientific 25 Tests 618 EUR

Nori® Equine CRP POCT Systems-25 Tests

GR223008 Genorise Scientific 25 Tests 299 EUR

Nori® Equine ANP POCT Systems-25 Tests

GR223010 Genorise Scientific 25 Tests 618 EUR

Nori® Equine ST2 POCT Systems-25 Tests

GR223016 Genorise Scientific 25 Tests 618 EUR

Rat Anti-Nuclear Antigens (ANA/ENA) IgG-specific ELISA Kit, 96 tests, Quantitative

650-230-ANA Alpha Diagnostics 1 Kit 854.4 EUR

Nori® Human PAPPA POCT Systems-25 Tests

GR220014 Genorise Scientific 25 Tests 618 EUR

Nori® Human sPLA2 POCT Systems-25 Tests

GR220018 Genorise Scientific 25 Tests 618 EUR

Nori® Canine GPBB POCT Systems-25 Tests

GR221009 Genorise Scientific 25 Tests 618 EUR

Nori® Canine MMP2 POCT Systems-25 Tests

GR221017 Genorise Scientific 25 Tests 618 EUR

Nori® Feline GPBB POCT Systems-25 Tests

GR222009 Genorise Scientific 25 Tests 618 EUR

Nori® Feline MMP2 POCT Systems-25 Tests

GR222017 Genorise Scientific 25 Tests 618 EUR

Nori® Equine GPBB POCT Systems-25 Tests

GR223009 Genorise Scientific 25 Tests 618 EUR

Nori® Equine MMP2 POCT Systems-25 Tests

GR223017 Genorise Scientific 25 Tests 618 EUR

Nori® Human MyBPC3 POCT Systems-25 Tests

GR220012 Genorise Scientific 25 Tests 618 EUR

Nori® Canine PAPPA POCT Systems-25 Tests

GR221014 Genorise Scientific 25 Tests 618 EUR

Nori® Canine sPLA2 POCT Systems-25 Tests

GR221018 Genorise Scientific 25 Tests 618 EUR

Nori® Feline PAPPA POCT Systems-25 Tests

GR222014 Genorise Scientific 25 Tests 618 EUR

Nori® Feline sPLA2 POCT Systems-25 Tests

GR222018 Genorise Scientific 25 Tests 618 EUR

Nori® Equine PAPPA POCT Systems-25 Tests

GR223014 Genorise Scientific 25 Tests 618 EUR

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

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