Genomic surveillance empowers agile responses to SARS-CoV-2 by enabling scientists and public health analysts to issue recommendations aimed at slowing transmission, prioritizing contact tracing, and building a robust genomic sequencing surveillance strategy. Since the start of the pandemic, real time RT-PCR diagnostic testing from upper respiratory specimens, such as nasopharyngeal (NP) swabs, has been the standard.
Moreover, respiratory samples in viral transport media are the ideal specimen for SARS-CoV-2 whole-genome sequencing (WGS). In early 2021, many clinicians transitioned to antigen-based SARS-CoV-2 detection tests, which use anterior nasal swabs for SARS-CoV-2 antigen detection. Despite this shift in testing methods, the need for whole-genome sequence surveillance remains. Thus, we developed a workflow for whole-genome sequencing with antigen test-derived swabs as an input rather than nasopharyngeal swabs. In this study, we use excess clinical specimens processed using the BinaxNOW COVID-19 Ag Card. We demonstrate that whole-genome sequencing from antigen tests is feasible and yields similar results from Rapid antigen test procedure RT-PCR-based assays utilizing a swab in viral transport media.
Diagnostic accuracy of a rapid diagnostic test for the early detection of COVID-19
- This study was undertaken to evaluate the diagnostic performance of the BinaxNOW COVID-19 Ag Card rapid antigen assay (Abbott; Chicago, IL, USA) in the detection of COVID-19 infection compared to the reference standard of PCR testing.
- We evaluated the BinaxNOW COVID-19 Ag Card rapid antigen assay relative to a standard reference PCR test. We tested 3810 nasal swabs from symptomatic and asymptomatic adults undergoing surveillance COVID-19 testing at Howard University using one swab for each nostril. One swab was tested using the rapid antigen assay and the other using the PCR test.
- The sensitivity of the BinaxNOW COVID-19 Ag Card rapid antigen assay was 91.84% (95% confidence interval (CI): 80.40-97.73%) and the specificity was 99.95% (95% CI: 99.81-99.99%). The range of Ct values for the N gene was 10.74-34.90 (M = 26.88, SD=4.86). Fourteen (28.6%) samples had an N gene Ct value > 30. The average N gene Ct value for rapid test negative (i.e. false negative) samples was 31.92.
- The sensitivity of the test in our symptomatic and asymptomatic cohort was lower than the manufacturer’s reported sensitivity in a symptomatic cohort (97.1%). Despite their relatively lower sensitivity (especially in asymptomatic individuals), rapid tests have undeniable benefits (i.e., ease of use and rapid results) that make them a helpful tool in the control of the SARS-CoV-2 pandemic. Given the diagnostic accuracy of these tests as evidenced by this study, rapid tests can be thoughtfully employed in situations where swift results are critical.

Clinical evaluation of the Diagnostic Analyzer for Selective Hybridization (DASH): a point-of-care PCR test for rapid detection of SARS-CoV-2 infection
- Rapid and accurate testing for SARS-CoV-2 is an essential tool in the medical and public health response to the COVID-19 pandemic. An ideal test for COVID-19 would combine the sensitivity of laboratory-based PCR combined with the speed and ease of use of point-of-care (POC) or home-based rapid antigen testing.
- To evaluate the performance of the Diagnostic Analyzer for Selective Hybridization (DASH) SARS-CoV-2 POC PCR (sample insertion to result time of 16 minutes), we conducted a cross-sectional study of adults with and without symptoms of COVID-19 at four clinical sites. We collected two bilateral anterior nasal swabs from each participant and information on COVID-19 symptoms, vaccination, and exposure. One swab was tested with the DASH SARS-CoV-2 POC PCR and the second in a central laboratory using Cepheid Xpert Xpress SARS-CoV-2 PCR. We assessed test concordance and calculated sensitivity, specificity, negative and positive predictive values using Xpert as the “gold standard.”
- We enrolled 315 and analyzed 313 participants with median age 42 years; 65% were female, 62% symptomatic, 75% had received ≥2 doses of mRNA COVID-19 vaccine, and 16% currently COVID-19 positive. There were concordant results for 307 tests indicating an overall agreement for DASH of 0.98 [95% CI 0.96, 0.99] compared to Xpert. DASH performed at 0.96 [95% CI 0.86, 1.00] sensitivity and 0.98 [95% CI 0.96, 1.00] specificity, with a positive predictive value of 0.85 [95% CI 0.73, 0.96] and negative predictive value of 0.996 [95% CI 0.99, 1.00]. The six discordant tests between DASH and Xpert all had high Ct values (>30) on the respective positive assay. DASH and Xpert Ct values were highly correlated (R=0.89 [95% CI 0.81, 0.94]).
- DASH POC SARS-CoV-2 PCR was accurate, easy to use, and provided fast results in real-life clinical settings with an overall performance similar to an EUA-approved laboratory-based PCR. Its compact design and ease of use are optimal for a variety of healthcare, and potentially community settings, including areas with lack of access to central laboratory-based PCR testing.
- DASH is an accurate, easy to use, and fast point-of-care test with applications for diagnosis and screening of SARS-CoV-2 infection.
Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Detection Tests Using Oral, Anterior Nasal, and Nasopharyngeal Swabs: a Diagnostic Accuracy Study
- The objective of our study was to evaluate the sensitivity and specificity of rapid antigen detection tests versus those of reverse transcriptase PCR (RT-PCR) using oral, anterior nasal, and nasopharyngeal swabs.
- The underlying prospective, diagnostic case-control-type accuracy study included 87 hospitalized and nonhospitalized participants in a positive and a negative sample cohort between 16 March and 14 May 2021 in two hospitals in Vienna.
- SARS-CoV-2 infection status was confirmed by RT-PCR. Participants self-performed one oral and one anterior nasal swab for the rapid antigen test, immediately followed by two nasopharyngeal swabs for the rapid antigen test and RT-PCR by the investigator.
- Test results were read after 15 min, and participants completed a questionnaire in the meantime. Test parameters were calculated based on the evaluation of 87 participants. The overall sensitivity of rapid antigen detection tests versus that of RT-PCR with oral, anterior nasal, and nasopharyngeal samples was 18.18% (95% confidence interval [CI] 8.19% to 32.71%), 63.04% (95% CI 47.55% to 76.79%), and 73.33% (95% CI 58.06% to 85.4%), respectively.
- All sampling methods had a test specificity of 100% regardless of the cycle threshold (CT) value. Rapid antigen detection tests using self-collected anterior nasal swabs proved to be as sensitive as and more tolerable than professionally collected nasopharyngeal swabs for CT values up to 30 determined by RT-PCR. This finding illustrates the reliability of tests obtained by adequate self-collected anterior nasal specimen. Sensitivity was dependent upon the CT value for each sampling method. While the main advantage of rapid antigen detection tests is the immediate availability of results, PCR should be preferred in crucial settings wherever possible.
- Rapid antigen detection devices for SARS-CoV-2 represent a valuable tool for monitoring the spread of infection. However, the reliability of the tests depends largely on the test performance and the respective sampling method. Nasopharyngeal swabs mark the gold standard for sample collection in suspected respiratory tract infections but are unsuitable for widespread application, as they must be performed by medically trained personnel.
SARS-CoV-2 Rapid Antigen Test Nasal |
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9901-NCOV-03G | Roche Diagnostics | 25 Tests/Kit |
Toc Vial Test (Purgin Method) 3-30Mg/L 25 Test/Box |
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WAT3672 | Scientific Laboratory Supplies | EACH |
SARS-CoV-2 Antigen Rapid Test Kit |
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CoV2Ag-25 | UnScience | 25T/kit |
TruStrip RDT Anthrax Protective antigen 83 (PA83) Rapid Test cards, 25/pk |
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800-100-RDT-25 | Alpha Diagnostics | 1 pk |
TruStrip RDT Mouse IgG Rapid Test cards, 25/pk |
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6320-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Rat IgG Rapid Test cards, 25/pk |
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6420-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Rabbit IgG Rapid Test cards, 25/pk |
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6520-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Goat IgG Rapid Test cards, 25/pk |
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7520-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Chicken IgY Rapid Test cards, 25/pk |
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6020-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Monkey IgG Rapid Test cards, 25/pk |
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7050-RDT-25 | Alpha Diagnostics | 1 Pk |
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TruStrip RDT Llama IgG Rapid test cards, 25/pk |
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20030-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Human Albumin Rapid test cards, 25/pk |
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1200-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Sheep IgG Rapid Test cards, 25/pk |
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7620-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Camel IgG Rapid test cards, 25/pk |
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7820-RDT-25 | Alpha Diagnostics | 1 Pk |
IAA (Anti-insulin antibody) ELISA test |
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25 | Biobase | 96T/Box |
CA125 (Cancer antigen) ELISA test |
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11 | Biobase | 96T/Box |
CA50 (Cancer antigen) ELISA test |
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10 | Biobase | 96T/Box |
CA153 (Cancer antigen) ELISA test |
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12 | Biobase | 96T/Box |
CA199 (Cancer antigen) ELISA test |
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13 | Biobase | 96T/Box |
CEA (Cancer antigen) ELISA test |
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9 | Biobase | 96T/Box |
NOVATest Antigen Rapid Test Kit (For Single Use) (NOVA Test) |
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nCov-500-01 | Atlas Link Technology | 1T |
25 mm Test Tube Foam Rack |
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MIX1116 | Scientific Laboratory Supplies | EACH |
TruStrip RDT Rabbit Albumin Rapid test cards, 25/pk |
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7000-30-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Cat Albumin Rapid test cards, 25/pk |
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7000-40-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Dog Albumin Rapid test cards, 25/pk |
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7000-50-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Human IgG Rapid test cards, 25/pk |
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20007-1-RDT-25 | Alpha Diagnostics | 1 Pk |
Accu-Tell COVID-19 IgG/IgM Rapid Test |
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GEN-B352-20tests | Accu test | 20 tests |
Accu-Tell COVID-19 IgG/IgM Rapid Test |
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GEN-B352-40tests | Accu test | 40 tests |
TruStrip RDT G. pig IgG Rapid Test cards, 25/pk |
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7420-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Dog Serum Albumin Rapid Test cards, 25/pk |
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7000-RDT-25 | Alpha Diagnostics | 1 Pk |
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1857-RDT-25 | Alpha Diagnostics | 1 pk |
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1858-RDT-25 | Alpha Diagnostics | 1 Pk |
Panbio™ COVID-19 Ag Rapid Test Device (Nasal) |
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41FK11 | Abbott | 25 Tests/Kit |
Test product |
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testtt | National Diagnostics | 0 |
TruStrip RDT Bovine Serum Albumin (BSA) Rapid Test cards, 25/pk |
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9000-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Cow/Bovine IgG (colostrum) Rapid Test cards, 25/pk |
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TruStrip RDT Cow/Bovine Transferrin (colostrum) Rapid Test cards, 25/pk |
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8070-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT Horse IgM (immunodeficiency syndrome) Rapid test cards, 25/pk |
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7740-RDT-25 | Alpha Diagnostics | 1 pk |
TruStrip RDT Human Procalcitonin (PCT) Rapid Test cards, 25 tests/pack |
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PCT-RDT-25 | Alpha Diagnostics | 1 pack |
PSA (Prostate-specific antigen) ELISA test |
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8 | Biobase | 96T/Box |
NOVATest Antigen Rapid Kit (NOVA Test) |
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nCov-500 | Atlas Link Technology | 20 Tests |
COD Test Kit 25 to 1500mg/L |
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WAT4314 | Scientific Laboratory Supplies | PK25 |
2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) |
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GEN-402-25tests | All test | 25 tests |
SARS-CoV-2 Antigen Rapid Test Kit |
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CoV2Ag-1 | UnScience | 1T |
HEV-Ag hepatitis E antigen ELISA test |
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94 | Biobase | 96T/Box |
HBeAg hepatitis B E antigen ELISA test |
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79 | Biobase | 96T/Box |
TruStrip RDT Human Serum Amyloid A (SAA) Rapid Test cards, 25 tests/pack |
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SAA-RDT-25 | Alpha Diagnostics | 1 pack |
DNASE TEST AGAR |
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D04-101-10kg | Alphabiosciences | 10 kg |
DNASE TEST AGAR |
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D04-101-2Kg | Alphabiosciences | 2 Kg |
DNASE TEST AGAR |
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D04-101-500g | Alphabiosciences | 500 g |
DERMATOPHYTE TEST AGAR |
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D04-107-10kg | Alphabiosciences | 10 kg |
DERMATOPHYTE TEST AGAR |
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D04-107-2Kg | Alphabiosciences | 2 Kg |
DERMATOPHYTE TEST AGAR |
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D04-107-500g | Alphabiosciences | 500 g |
MOTILITY TEST MEDIUM |
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M13-121-10kg | Alphabiosciences | 10 kg |
MOTILITY TEST MEDIUM |
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M13-121-2Kg | Alphabiosciences | 2 Kg |
MOTILITY TEST MEDIUM |
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M13-121-500g | Alphabiosciences | 500 g |
SNYDER TEST AGAR |
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S19-119-10kg | Alphabiosciences | 10 kg |
SNYDER TEST AGAR |
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S19-119-2Kg | Alphabiosciences | 2 Kg |
SNYDER TEST AGAR |
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S19-119-500g | Alphabiosciences | 500 g |
SAM Test Strip |
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TS00201s-30 | Arthus | 30 tests |
SAH Test Strip |
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TS00301s-30 | Arthus | 30 tests |
HCY Test Strip |
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Phenols Cuvette Test |
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LCK345 | Scientific Laboratory Supplies | EACH |
Dermatophyte Test Medium |
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MED1484 | Scientific Laboratory Supplies | EACH |
Test for Enteropathogenic.C |
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MIC6774 | Scientific Laboratory Supplies | PK50 |
Sulphite Test Strips |
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MN91306 | Scientific Laboratory Supplies | PK100 |
Thermal Test Film |
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PCR0890 | Scientific Laboratory Supplies | PK25 |
Dryslide Oxidase Test |
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231746 | Scientific Laboratory Supplies | PK75 |
Test Tube 16x100mm |
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3840/16X100 | Scientific Laboratory Supplies | PK100 |
5mL Test Tubes |
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TUB0228 | Scientific Laboratory Supplies | PK1400 |
Spectroquant COD test |
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WAT1080 | Scientific Laboratory Supplies | EACH |
Phosphate Total Test |
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WAT3655 | Scientific Laboratory Supplies | EACH |
TruStrip RDT Chicken Egg Ovalbumin (Ova/Gal d 2) Rapid Test cards, 25/pk |
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6050-RDT-25 | Alpha Diagnostics | 1 Pk |
TruStrip RDT 5-minute Horse meat detection/adulteration rapid test cards, 25 tests/pk |
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RDT-6050H-25 | Alpha Diagnostics | 1 pk |
NOVATest IgG/IgM Antibody Rapid Test Kit (NOVA Test) |
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UNCOV-40 | Atlas Link Technology | 40 Tests |
Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit |
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abx092096-20tests | Abbexa | 20 tests |
TruStrip RDT Horse/Foal IgG (Failure of passive transfer, FPT) Rapid test cards, 25/pk |
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7730-RDT-25 | Alpha Diagnostics | 1 Pk |
Test Tube Rack Holder (for 50 Ml Test Tube Racks) |
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480169 | Scientific Laboratory Supplies | EACH |
Basic Cytotoxicity Test Kits |
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CT17001 | Neuromics | 125 Tests |
Basic Cytotoxicity Test Kits |
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CT17002 | Neuromics | 250 Tests |
Total Cytotoxicity Test Kits |
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CT17003 | Neuromics | 125 Tests |
Total Cytotoxicity Test Kits |
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CT17004 | Neuromics | 250 Tests |
FERR ( Ferritin) ELISA test |
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7 | Biobase | 96T/Box |
PRL (Prolactin) ELISA test |
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4 | Biobase | 96T/Box |
E2 (Estradiol) ELISA test |
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5 | Biobase | 96T/Box |
CA72-4 ELISA test |
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24 | Biobase | 96T/Box |
PROG (Progesterone) ELISA test |
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20 | Biobase | 96T/Box |
TESTO (Testosterone) ELISA test |
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19 | Biobase | 96T/Box |
TSH (Thyrotrophin) ELISA test |
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14 | Biobase | 96T/Box |
T3 (Triiodothyronine) ELISA test |
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15 | Biobase | 96T/Box |
T4 (Thyroxine) ELISA test |
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16 | Biobase | 96T/Box |
Syphilis Antibody ELISA test |
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100 | Biobase | 96T/Box |
Melamine Rapid Test Kit |
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abx092011-50tests | Abbexa | 50 tests |
HBcAb Sandwich ELISA test |
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95 | Biobase | 96T/Box |
Hach Test Kit CYANIDE |
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LCK315 | Scientific Laboratory Supplies | EACH |
Hach Test Kit FLUORIDE |
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LCK323 | Scientific Laboratory Supplies | EACH |
Hach Test Kit COPPER |
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LCK329 | Scientific Laboratory Supplies | EACH |
Anionic Surfactants Cuvette Test |
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LCK332 | Scientific Laboratory Supplies | EACH |
With the underlying study, the head-to-head test performance and the usability of self-collected samples for SARS-CoV-2 detection using rapid antigen detection devices were evaluated. The results confirm similar sensitivity of self-collected anterior nasal swabs to that of professionally collected nasopharyngeal swabs for patients with a CT of < 30 determined by RT-PCR.