Evaluation of the INDICAID COVID-19 Rapid Antigen Test in Symptomatic Populations and Asymptomatic Community Testing
As the COVID-19 pandemic progresses, there is an increasing need for rapid, accessible assays for SARS-CoV-2 detection. We present a clinical evaluation and real-world implementation of the INDICAID COVID-19 rapid antigen test (INDICAID rapid test). A multisite clinical evaluation of the INDICAID rapid test using prospectively collected nasal (bilateral anterior) swab samples from symptomatic subjects was performed. The INDICAID rapid test demonstrated a positive percent agreement (PPA) and negative percent agreement (NPA) of 85.3% (95% confidence interval [95% CI], 75.6% to 91.6%) and 94.9% (95% CI, 91.6% to 96.9%), respectively, compared to laboratory-based reverse transcriptase PCR (RT-PCR) using nasal specimens.
The INDICAID rapid test was then implemented at COVID-19 outbreak screening centers in Hong Kong as part of a testing algorithm (termed “dual-track”) to screen asymptomatic individuals for prioritization for confirmatory RT-PCR testing. In one approach, preliminary positive INDICAID rapid test results triggered expedited processing for laboratory-based RT-PCR, reducing the average time to confirmatory result from 10.85 h to 7.0 h. In a second approach, preliminary positive results triggered subsequent testing with an onsite rapid RT-PCR, reducing the average time to confirmatory result to 0.84 h. In 22,994 asymptomatic patients, the INDICAID rapid test demonstrated a PPA of 84.2% (95% CI, 69.6% to 92.6%) and an NPA of 99.9% (95% CI, 99.9% to 100%) compared to laboratory-based RT-PCR using combined nasal/oropharyngeal specimens. The INDICAID rapid test has excellent performance compared to laboratory-based RT-PCR testing and, when used in tandem with RT-PCR, reduces the time to confirmatory positive result.
Laboratory-based RT-PCR, the current gold standard for COVID-19 testing, can require a turnaround time of 24 to 48 h from sample collection to result. The delayed time to result limits the effectiveness of centralized RT-PCR testing to reduce transmission and stem potential outbreaks. To address this, we conducted a thorough evaluation of the INDICAID COVID-19 rapid antigen test, a 20-minute rapid antigen test, in both symptomatic and asymptomatic populations. The INDICAID rapid test demonstrated high sensitivity and specificity with RT-PCR as the comparator method.
A dual-track testing algorithm was also evaluated utilizing the INDICAID rapid test to screen for preliminary positive patients, whose samples were then prioritized for RT-PCR testing. The dual-track method demonstrated significant improvements in expediting the reporting of positive RT-PCR test results compared to standard RT-PCR testing without prioritization, offering an improved strategy for community testing and controlling SARS-CoV-2 outbreaks.
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.
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.
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.
OraSure InteliSwa Rapid Antigen Test performance with the SARS-CoV-2 Variants of Concern Alpha, Beta, Gamma, Delta, and Omicron
The emergence of SARS-CoV-2 in the human population and the resulting COVID-19 pandemic has led to the development of various diagnostic tests. The OraSure InteliSwab COVID-19 Rapid Test is a recently developed and FDA emergency use authorized rapid antigen-detecting test that functions as a lateral flow device targeting the nucleocapsid protein. Due to SARS-CoV-2 evolution, there is a need to evaluate the sensitivity of rapid antigen-detecting tests for new variants, especially variants of concern like Omicron. In this study, the sensitivity of the OraSure InteliSwab Test was investigated using cultured strains of the known variants of concern (VOCs, Alpha, Beta, Gamma, Delta, and Omicron) and the ancestral lineage (lineage A).
SARS-CoV-2 Antigen Rapid Test Kit | ||||
| CoV2Ag-1 | UnScience | 1T | 9.6 EUR | |
SARS-CoV-2 Antigen Rapid Test Kit | ||||
| CoV2Ag-25 | UnScience | 25T/kit | 42 EUR | |
NOVATest Antigen Rapid Test Kit (For Single Use) (NOVA Test) | ||||
| nCov-500-01 | Atlas Link Technology | 1T | 162 EUR | |
NOVATest Antigen Rapid Kit (NOVA Test) | ||||
| nCov-500 | Atlas Link Technology | 20 Tests | 162 EUR | |
SARS-CoV-2 Rapid Antigen Test Nasal | ||||
| 9901-NCOV-03G | Roche Diagnostics | 25 Tests/Kit | 112.8 EUR | |
Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit | ||||
| abx092096-20tests | Abbexa | 20 tests | 477.6 EUR | |
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 | |
Newcastle Disease Virus Antigen Rapid Test Kit (Colloidal gold) | ||||
| abx092016-40tests | Abbexa | 40 tests | 518.4 EUR | |
Human Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal gold) | ||||
| abx092049-20tests | Abbexa | 20 tests | 276 EUR | |
Avian Influenza H5 Virus Antigen Rapid Test Kit (Colloidal gold) | ||||
| abx092014-40tests | Abbexa | 40 tests | 585.6 EUR | |
Avian Influenza H7 Virus Antigen Rapid Test Kit (Colloidal gold) | ||||
| abx092017-40tests | Abbexa | 40 tests | 518.4 EUR | |
Accu-Tell COVID-19 IgG/IgM Rapid Test | ||||
| GEN-B352-20tests | Accu test | 20 tests | 283.2 EUR | |
Accu-Tell COVID-19 IgG/IgM Rapid Test | ||||
| GEN-B352-40tests | Accu test | 40 tests | 385.2 EUR | |
TruStrip RDT Anthrax Protective antigen 83 (PA83) Rapid Test cards, 25/pk | ||||
| 800-100-RDT-25 | Alpha Diagnostics | 1 pk | 489.6 EUR | |
2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | ||||
| GEN-402-25tests | All test | 25 tests | 292.8 EUR | |
TruStrip RDT Zaire Ebola Virus antigen (GP) rapid test (visual results in 2-10 mins), 10 cassettes/pk | ||||
| AE-320805-RDT-10 | Alpha Diagnostics | 1 pk | 343.2 EUR | |
Based on dilution series in cell culture medium, an approximate limit of detection for each variant was determined. The OraSure InteliSwab Test showed an overall comparable performance using recombinant nucleocapsid protein and different cultured variants with recorded limits of detection ranging between 3.77 × 10 5 and 9.13 × 10 5 RNA copies/mL. Finally, the sensitivity was evaluated using oropharyngeal swabs from Syrian golden hamsters inoculated with the 6 VOCs. Ultimately, the OraSure InteliSwab ® COVID-19 Rapid Test showed no decrease in sensitivity between the ancestral SARS-CoV-2 strain and any VOCs including Omicron.