Performance of qualitative and quantitative antigen tests for SARS-CoV-2 in early symptomatic patients using saliva

AbstractBackgroundThe rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an urgent need for the prevention and containment of disease outbreaks in communities. Although the gold standard is polymerase chain reaction (PCR), antigen tests such as immunochromatographic assay (ICA) and chemiluminescent enzyme immunoassay (CLEIA) that can yield results within 30 minutes.MethodsWe evaluated performance of ICA and CLEIA using 34 frozen PCR-positive specimens (17 saliva and 17 nasopharyngeal swab) and 307 PCR-negative samples.ResultsICA detected SARS-CoV-2 in only 14 (41%) samples, with positivity of 24% in saliva and 59% in NPS. Notably, ICA detected SARS-CoV-2 in 5 (83%) of 6 samples collected within 4 days after symptom onset. CLEIA detected SARS-CoV-2 in 31 (91%) samples, with positivity of 82% in saliva and 100% in NPS. CLEIA was negative in 3 samples with low viral load by PCR.ConclusionsThese results suggest that use of ICA should be limited to earlier time after symptom onset and CLEIA is more sensitive and can be used in situations where quick results are required.

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Performance of Qualitative and Quantitative Antigen Tests for SARS-CoV-2 Using Saliva

Infectious Disease Reports ◽

10.3390/idr13030069 ◽

2021 ◽

Vol 13 (3) ◽

pp. 742-747

Author(s):

Isao Yokota ◽

Takayo Sakurazawa ◽

Junichi Sugita ◽

Sumio Iwasaki ◽

Keiko Yasuda ◽

...

Keyword(s):

Enzyme Immunoassay ◽

Symptom Onset ◽

Rapid Detection ◽

Disease Outbreaks ◽

Immunochromatographic Assay ◽

Qualitative And Quantitative ◽

Antigen Tests ◽

Chemiluminescent Enzyme Immunoassay

The rapid detection of SARS-CoV-2 is critical for the prevention of disease outbreaks. Antigen tests such as immunochromatographic assay (ICA) and chemiluminescent enzyme immunoassay (CLEIA) can yield results more quickly than PCR. We evaluated the performance of ICA and CLEIA using 34 frozen PCR-positive (17 saliva samples and 17 nasopharyngeal swabs [NPS]) and 309 PCR-negative samples. ICA detected SARS-CoV-2 in only 14 (41%) samples, with positivity rates of 24% in saliva and 59% in NPS. Notably, ICA detected SARS-CoV-2 in 5 of 6 samples collected within 4 days after symptom onset. CLEIA detected SARS-CoV-2 in 31 (91%) samples, with a positivity of 82% in saliva and 100% in NPS. These results suggest that the use of ICA should be limited to an earlier time after symptom onset and CLEIA is more sensitive and can be used in situations where quick results are required.

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Effectivity Analysis of SARS-CoV-2 Nasopharyngeal Swab Rapid Testing Kits in Pakistan: A Scenario of Inadequate COVID-19 Diagnosis

10.21203/rs.3.rs-315851/v1 ◽

2021 ◽

Cited By ~ 1

Author(s):

Umar Saeed ◽

Sara Rizwan Uppal ◽

Zahra Zahid Piracha ◽

Aftab Ahmad Khan ◽

Azhar Rasheed ◽

...

Keyword(s):

Gold Standard ◽

Rapid Detection ◽

International Health ◽

Time Frame ◽

Cross Sectional Study ◽

Nasopharyngeal Swab ◽

Rt Pcr ◽

Cross Sectional ◽

International Health Organizations ◽

Polymerase Chain

Abstract COVID-19 pandemic has urged the need of rapid detection of SARS-CoV-2 in limited time frame. To cope with current, COVID-19 expanding scenario, accurate diagnosis of SARS-CoV-2 should be ensured by both national and international health organizations. Sporadic marketing of SARS-CoV-2 rapid detection kits raises questions regarding quality control and assurance. To aim of this study was to examine the effectiveness of SARS-CoV-2 nasopharyngeal swab based rapid detection kits, in comparison to gold standard USFDA approved triple target real-time polymerase chain reaction. A cross-sectional study of 1500 suspected COVID-19 patients was conducted. 100 RT-PCR confirmed patients nasopharyngeal swabs were evaluated for RDT. The COVID-19/SARS-CoV-2 NSP based RDT analysis showed 78% reactivity. Among RT-PCR confirmed negative subjects, 49.3% showed false positivity. The positive predictive analysis revealed 67.82% values, while the negative predictive vales of were 64.40%. The NSP RDTs showed limited sensitivities and specificities compared to gold standard RT-PCR. Accurate surveillance of COVID-19 is dependent upon authentic and validated SARS-CoV-2 detection nation-wide, which needs to be monitored by higher authorities. This study is critical for designing adequate measures by several COVID-19 strategic organizations to prevent future viral epidemics.

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Real-World Clinical Performance of the Abbott Panbio with Nasopharyngeal, Throat and Saliva Swabs Among Symptomatic Individuals with COVID-19

10.21203/rs.3.rs-188293/v1 ◽

2021 ◽

Author(s):

William Stokes ◽

Byron M. Berenger ◽

Danielle Portnoy ◽

Brittney Scott ◽

Jonas Szelewicki ◽

...

Keyword(s):

Symptom Onset ◽

Clinical Performance ◽

Point Of Care ◽

Community Setting ◽

Rt Pcr ◽

Chain Reaction ◽

False Negatives ◽

Polymerase Chain ◽

Antigen Tests ◽

Health Canada

Abstract BACKGROUND Point of Care SARS-CoV-2 antigen tests, such as the Abbott Panbio, have great potential to help combat the COVID-19 pandemic. The Panbio is Health Canada approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of COVID-19 symptom onset(s). METHODS Symptomatic adults recently diagnosed with COVID-19 in the community were recruited into the study. Paired nasopharyngeal (NP), throat, and saliva swabs were collected, with one paired swab tested immediately with the Panbio, and the other transported in universal transport media and tested using reverse-transcriptase polymerase chain reaction (RT-PCR). We also prospectively evaluated results from assessment centres. For those individuals, an NP swab was collected for Panbio testing and paired with RT-PCR results from parallel NP or throat swabs. RESULTS 145 individuals were included in the study. Collection of throat and saliva was stopped early due to poorer performance (throat sensitivity 57.7%, n = 61, and saliva sensitivity 2.6%, n = 41). NP swab sensitivity was 87.7% [n = 145, 95% confidence interval (CI) 81.0% − 92.7%]. There were 1,641 symptomatic individuals tested by Panbio in assessment centres, with 268/1641 (16.3%) positive for SARS-CoV-2. There were 37 false negatives and 2 false positives, corresponding to a sensitivity and specificity of 86.1% [95% CI 81.3% − 90.0%] and 99.9% [95% CI 99.5% − 100.0%], respectively. CONCLUSIONS The Panbio test reliably detects most cases of SARS-CoV-2 from adults in the community setting presenting within 7 days of symptom onset using nasopharyngeal swabs. Throat and saliva swabs are not reliable specimens for the Panbio.

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Evaluation of A Chemiluminescent Enzyme Immunoassay-Based High-Throughput SARS-CoV-2 Antigen Assay For The Diagnosis of COVID-19: The VITROS® SARS-CoV-2 Antigen Test

10.21203/rs.3.rs-475980/v1 ◽

2021 ◽

Author(s):

Nanako Matsuzaki ◽

Yuta Orihara ◽

Masahiro Kodana ◽

Yutaro Kitagawa ◽

Masaru Matsuoka ◽

...

Keyword(s):

Polymerase Chain Reaction ◽

High Throughput ◽

Nasopharyngeal Swab ◽

Antigen Test ◽

Chain Reaction ◽

Viral Loads ◽

Antigen Assay ◽

Polymerase Chain ◽

Dose Dependent ◽

Chemiluminescent Enzyme Immunoassay

Abstract A high-throughput, fully automated antigen detection test for SARS-CoV-2 is a viable alternative to reverse transcription polymerase chain reaction (RT-qPCR) for mass screening during outbreaks. In this study, we compared RT-qPCR for viral load and the VITROS® SARS-CoV-2 Antigen Test with reference to the results of the LUMIPULSE® SARS-CoV-2 Ag Test. Of 128 nasopharyngeal swab specimens taken from patients suspected of being infected with SARS-CoV-2, 49 were positive and 79 were negative according to RT-qPCR. Consistent dose-dependent detection with VITROS® assay was successfully achieved when using nasopharyngeal swab specimens with Ct values of ≤32.0, whereas the CLEIA-based the LUMIPULSE® assay was able to detect lower viral loads compared with the VITROS® assay. Our results show that the performance of the VITROS® assay was satisfactory for the diagnosis of contagious COVID-19 patients in the clinical setting.

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Rapid detection of Streptococcus iniae in red tilapia tissue (Oreochromis sp.) by polymerase chain reaction

Can Tho University Journal of Science ◽

10.22144/ctu.jen.2016.004 ◽

2016 ◽

Vol 02 ◽

pp. 84

Author(s):

Phuong, N.M. ◽

Hoa, T.T.T.

Keyword(s):

Polymerase Chain Reaction ◽

Rapid Detection ◽

Streptococcus Iniae ◽

Chain Reaction ◽

Red Tilapia ◽

Polymerase Chain

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A comparative evaluation of two chromogenic media for surveillance of carbapenem-resistant Enterobacterales with non-carbapenemase-producing or carbapenemase-producing strains other than blaKPC: blaGES-5, blaNDM-1 or blaVIM-2

Journal of Laboratory Medicine ◽

10.1515/labmed-2018-0139 ◽

2019 ◽

Vol 43 (3) ◽

pp. 173-176

Author(s):

Chang-Hun Park

Keyword(s):

Rapid Detection ◽

Comparative Evaluation ◽

Susceptibility Testing ◽

Rapid Identification ◽

Surveillance Program ◽

Contact Precaution ◽

Chain Reaction ◽

Carbapenem Resistant ◽

Control And Prevention ◽

Polymerase Chain

Abstract Background Infections caused by carbapenem-resistant Enterobacterales (CREs) are an emerging problem associated with high rates of morbidity and mortality. CREs are divided into two categories (carbapenemase-producing [CP] CRE and non-CP CRE). The most prevalent carbapenemase produced by Enterobacterales is Klebsiella pneumoniae carbapenemase (KPC) in Korea. Rapid identification of CREs is clinically important in infection control precaution. We compared the performance of two chromogenic media (chromID CARBA agar and CHROMagar KPC agar) for non-CP CREs or CP CREs with blaGES-5, blaNDM-1 or blaVIM-2 in a Korean hospital. Methods The study was carried out during a 3-month period from April to June 2017 during the surveillance program for CRE colonization. Antimicrobial susceptibility testing (AST) and polymerase chain reaction (PCR) were performed at the Korean Centers for Disease Control and Prevention. Results A total of 45 rectal swabs from 42 hospitalized patients were examined. Sensitivity of both chromID CARBA and CHROMagar KPC were 100% for CP CREs; and 50% and 100% for non-CP CREs, respectively. Specificity of chromID CARBA and CHROMagar KPC were 89.2% and 70.3% for CP CRE, respectively; and 76.9% and 66.7% for non-CP CRE, respectively. Conclusions The CHROMagar KPC is useful to monitor non-CP and CP CREs. The chromID CARBA is efficient for rapid detection of CP CREs requiring high contact precaution.

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