Rapid Antigen Test in symptomatic populations and asymptomatic community testing

In contrast, lateral flow immunoassays (LFAs) are an inexpensive testing solution that can be used at point-of-care settings, do not require laboratory equipment, and can generate results quickly. However, the performance of LFA-based SARS-CoV-2 rapid antigen tests in community testing settings can vary significantly .

In this study, we evaluated the clinical performance of the LFA-based INDICAIDCOVID-19 Rapid Antigen Test (INDICAID Rapid Test) by PHASE Scientific International Ltd. A prospective multi-site clinical study was performed in symptomatic patient populations in point-of-care (POC) community testing sites in the United States. The performance of the INDICAID Rapid Test was also evaluated in COVID-19 outbreak screening centers in Hong Kong as a part of an algorithm testing approach (termed “Dual-Track”) to screen for COVID-19 positive patients prior to RT-PCR testing in asymptomatic patient populations.

The global SARS-CoV-2 pandemic has continued despite implementation of significant public health measures .

Over 155 million worldwide cases of COVID-19 and over 3 million COVID-19 deaths have been reported as of May 2021. Rapid identification of SARS-CoV-2 infection, patient isolation, and contact tracing are essential for disease containment .

The current gold standard for detecting SARS-CoV-2 is reverse-transcriptase polymerase chain reaction (RT-PCR) . While RT-PCR can detect nucleic acids from SARS-CoV-2 with high sensitivity, RT-PCR requires equipment, special training, and can take days until results are available following sample collection . Due to the uniquely high transmissibility of SARS-CoV-2 (basic reproductive number R0 of 2.87), long turnaround times for results may lead to a high number of avoidable transmissions .

Description of the INDICAID COVID-19 Rapid Antigen Test

The INDICAID Rapid Test by PHASE Scientific is a LFA designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein in nasal swab samples. The test produces a simple readout within 20 minutes with the presence of a visible test line to indicate detection of the SARS-CoV-2 antigen. In contrast to other reader-based rapid antigen platforms, the INDICAID Rapid Test achieves results without any additional equipment, power source, or training.

Sample collection and procedure of the INDICAID COVID-19 Rapid Antigen Test

To conduct an INDICAID Rapid Test, a nasal swab sample is collected by inserting the provided swab 1 inch into the nasal cavity. The swab is rubbed against the inside walls of both nostrils 5 times in a large circular path. The swab is then dipped into a buffer solution to elute the sample. Finally, three drops of the buffer solution-specimen mix are applied to the LFA test device. After 20 minutes, the user observes the test device for the presence or absence of a test line that indicates detection of the SARS-CoV-2 antigen. An Internal Quality Control line is included to indicate whether the test has been performed correctly.

Prospective multi-site clinical evaluation of INDICAID™ COVID-19 Rapid Antigen Test

Populations and study locations

Between November 30, 2020 and January 8, 2021, study participants were enrolled at two US clinical sites, CityHealth Urgent Care San Francisco, CA and CityHealth Urgent Care Oakland, CA.

As part of the inclusion criteria, study participants were required to be at least 5 years of age and report onset of at least two of the following COVID-19 symptoms within 5 days or less: fever or chills, fatigue, sore throat, congestion or runny nose, cough, headache, diarrhea, shortness of breath or difficulty breathing, muscle or body aches, new loss of taste or smell, nausea, or vomiting. A patient enrichment strategy was implemented to increase the rate of SARS-CoV-2 positive participants enrolled at the CityHealth Urgent Care Oakland, CA site. For this strategy, patients presenting at the clinic were first tested by CityHealth Urgent Care staff, as part of the standard-of-care, with an FDA EUA rapid antigen test (Quidel Sofia SARS Antigen FIA) to pre-screen potential subjects prior to study enrollment. CityHealth Urgent Care staff were asked to identify patients with preliminary positive or negative results for study screening. The trained study operators, blinded to the original patient standard-of-care result, performed specimen collection, processing, and testing. An equal number of positives and negatives were pre-screened by the CityHealth Urgent Care staff at the CityHealth Urgent Care Oakland, CA site. Five unique study operators with varying healthcare backgrounds (licensed medical assistants and registered nurses) conducted the study between the two sites.

Between February 6, 2021 and March 9, 2021, study participants were enrolled at a third US clinical testing site (San Fernando Recreation Park in San Fernando, CA) who were at least 5 years of age and reported at least one of the COVID-19 symptoms listed above. Five unique study operators with varying healthcare backgrounds (licensed medical assistants and registered nurses) conducted the study at the San Fernando, CA site.

Testing procedure

Following the standard of care, patients were asked to provide a total of three nasal swab samples: a self-collected and observed nasal swab sample, followed by a second and third nasal swab sample that were collected by the health care provider (HCP). For the self-collected sample, the HCP provided specimen collection instructions and observed the specimen collection by the patient. The order of the second and third HCP-collected samples was randomized for testing with the investigational antigen test and a comparator method to ensure that bias was not introduced due to unequal distribution of viral material. Immediately after sample collection, the samples for the RT-PCR reference method were stored in viral transport media, while the other two nasal swabs were tested directly with the INDICAID Rapid Test according to the instructions for use (IFU).

INDICAID Rapid Test samples were tested immediately on-site after collection with no storage in accordance with the manufacturer’s protocol. Results of the INDICAID Rapid Test were interpreted by the test operators and recorded as “Positive,” “Negative”, or “Invalid” based on the visual presence or absence of the control and test lines on the developed test strip. Test results were recorded after 20 minutes of assay development by one individual operator per participant.

SARS-CoV-2 Antigen Rapid Test Kit

CoV2Ag-1 UnScience 1T 8 EUR

SARS-CoV-2 Antigen Rapid Test Kit

CoV2Ag-25 UnScience 25T/kit 35 EUR

SARS-CoV-2 Rapid Antigen Test Nasal

9901-NCOV-03G Roche Diagnostics 25 Tests/Kit 94 EUR

Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit

abx092096-20tests Abbexa 20 tests 398 EUR

NDV rapid test kit

RG15-03 Bionote 1 box 139.05 EUR

IBD rapid test strip

RG15-04 Bionote 10 boxes 148 EUR

Rabies rapid test strip

RG18-01 Bionote 10 boxes 151.92 EUR

Melamine Rapid Test Kit

abx092011-50tests Abbexa 50 tests 370 EUR

Accu-Tell COVID-19 IgG/IgM Rapid Test

GEN-B352-20tests Accu test 20 tests 236 EUR

Accu-Tell COVID-19 IgG/IgM Rapid Test

GEN-B352-40tests Accu test 40 tests 321 EUR

Avian Influenza Virus Antigen Rapid Test Kit (Colloidal gold)

abx092015-40tests Abbexa 40 tests 432 EUR

Newcastle Disease Virus Antigen Rapid Test Kit (Colloidal gold)

abx092016-40tests Abbexa 40 tests 432 EUR

Human Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal gold)

abx092049-20tests Abbexa 20 tests 230 EUR

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

IOV87952 INVBIO 20T/kit 39 EUR

Rapid Leishmania Ab Test Kit

RB2104 Bionote 1 box 127 EUR

Rapid PED Ag Test Kit

RG14-01 Bionote 1 box 159.9 EUR

Melamine (MEL) Rapid Test Kit

abx092057-50tests Abbexa 50 tests 370 EUR

Clenbuterol (CLE) Rapid Test Kit

abx092058-50tests Abbexa 50 tests 244 EUR

Ractopamine (RAC) Rapid Test Kit

abx092059-50tests Abbexa 50 tests 244 EUR

Salbutamol (SAL) Rapid Test Kit

abx092060-50tests Abbexa 50 tests 244 EUR

Tetracycline (TCs) Rapid Test Kit

abx092063-50tests Abbexa 50 tests 398 EUR

Sulfonamides (Sas) Rapid Test Kit

abx092064-40tests Abbexa 40 tests 398 EUR

Quinolones (QNs) Rapid Test Kit

abx092065-40tests Abbexa 40 tests 398 EUR

Ciprofloxacin (CPFX) Rapid Test Kit

abx092066-50tests Abbexa 50 tests 398 EUR

Quinolones (QNs) Rapid Test Kit

abx092067-40tests Abbexa 40 tests 398 EUR

Brucella Antibody Rapid Test Kit

abx092069-40tests Abbexa 40 tests 356 EUR

Procalcitonin rapid test (Colloidal Gold)

abx095264-80Units Abbexa 80 Units 954 EUR

Avian Influenza H5 Virus Antigen Rapid Test Kit (Colloidal gold)

abx092014-40tests Abbexa 40 tests 488 EUR

Avian Influenza H7 Virus Antigen Rapid Test Kit (Colloidal gold)

abx092017-40tests Abbexa 40 tests 432 EUR

Anigen Rapid FIV Ab Test Kit

RB22-01-DD Bionote 10 tests/Kit 129.8 EUR

Rapid Bovine Brucella Ab Test Kit

RB23-01-DD Bionote 1 kit/10 tests 151.79 EUR

Rapid Bovine TB Ab Test Kit

RB23-02-DD Bionote 1 box 128.4 EUR

Rapid FMD NSP Ab Test Kit

RB28-02-DD Bionote 1 box 135.4 EUR

Ag rapid CDV Ag Test Kit

RG11-03 Bionote 1 box 138.2 EUR

Rapid TGE/PED Ag Test Kit

RG14-03 Bionote 1 box 240.85 EUR

Ag Rapid AIV Ag Test Kit

RG15-01 Bionote 1 box/30 tests 267 EUR

Ag Rapid H5AIV Ag test kit

RG15-05 Bionote 1 box 463 EUR

Clenbuterol Rapid Test Kit (Colloidal gold)

abx092040-50tests Abbexa 50 tests 272 EUR

Ractopamine Rapid Test Kit (Colloidal gold)

abx092042-50tests Abbexa 50 tests 300 EUR

Salbutamol Rapid Test Kit (Colloidal gold)

abx092043-50tests Abbexa 50 tests 342 EUR

Chloramphenicol Rapid Test Kit (Colloidal gold)

abx092045-50tests Abbexa 50 tests 356 EUR

Quinolones Rapid Test Kit (Colloidal gold)

abx092046-50tests Abbexa 50 tests 537 EUR

Sulfonamides Rapid Test Kit (Colloidal gold)

abx092047-50tests Abbexa 50 tests 551 EUR

Tetracycline Rapid Test Kit (Colloidal gold)

abx092048-50tests Abbexa 50 tests 467 EUR

Zearalenone Rapid Test Kit (Colloidal gold)

abx092051-50tests Abbexa 50 tests 411 EUR

Deoxynivalenol Rapid Test Kit (Colloidal gold)

abx092052-50tests Abbexa 50 tests 467 EUR

Deoxynivalenol Rapid Test Kit (Colloidal gold)

abx092053-50tests Abbexa 50 tests 467 EUR

Aflatoxin Rapid Test Kit (Colloidal gold)

abx092054-50tests Abbexa 50 tests 398 EUR

Zearalenone Rapid Test Kit (Colloidal gold)

abx092056-50tests Abbexa 50 tests 425 EUR

Goat Brucella Antibody Rapid Test Kit

abx092070-40tests Abbexa 40 tests 356 EUR

Cow Brucella Antibody Rapid Test Kit

abx092071-40tests Abbexa 40 tests 356 EUR

Pig Parvovirus Antibody Rapid Test Kit

abx092074-50tests Abbexa 50 tests 321 EUR

Fetal Fibronectin rapid test (Colloidal Gold)

abx095261-80Units Abbexa 80 Units 1553 EUR

Dynamiker Monkeypox Virus Ag Rapid Test

DNK-2114-1 Dynamiker Biotechnology 20 tests 585 EUR

Chlamydia Rapid Test Device (Swab/Urine)

173-8537306 Abbott 20 Tests/Kit 250 EUR

2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GEN-402-25tests All test 25 tests 244 EUR

TruStrip RDT Anthrax Protective antigen 83 (PA83) Rapid Test cards, 25/pk

800-100-RDT-25 Alpha Diagnostics 1 pk 408 EUR

NATtrol Zika Virus Stock (Qualitative) (1 mL)

TEST Zeptometrix 1 mL 1106.64 EUR

Ag Rapid Bov. TB Ab Test Kit

RB23-02 Bionote 1 box 145 EUR

Ag Rapid FMD NSP Ab Test Kit

RB28-02 Bionote 1 box 108.52 EUR

Ag Rapid CIRD-3 Ag Test Kit

RG11-09 Bionote 1 box 123.64 EUR

Bionote Rapid AIV Ag_NDV Ag Test Kit

RG15-09 Bionote 1 box 164.52 EUR

Furaltadone Metabolite Rapid Test Kit (Colloidal gold)

abx092035-50tests Abbexa 50 tests 537 EUR

Furazolidone Metabolite Rapid Test Kit (Colloidal gold)

abx092036-50tests Abbexa 50 tests 537 EUR

Aminohydantoin Hydrochloride Rapid Test Kit (Colloidal gold)

abx092037-50tests Abbexa 50 tests 537 EUR

Nitrofurazone Metabolite Rapid Test Kit (Colloidal gold)

abx092038-50tests Abbexa 50 tests 537 EUR

Malachite Green Rapid Test Kit (Colloidal gold)

abx092041-10tests Abbexa 10 tests 300 EUR

Phenylethanolamine A Rapid Test Kit (Colloidal gold)

abx092044-50tests Abbexa 50 tests 467 EUR

Aflatoxin B1 Rapid Test Kit (Colloidal gold)

abx092050-50tests Abbexa 50 tests 370 EUR

Aflatoxin B1 Rapid Test Kit (Colloidal gold)

abx092055-50tests Abbexa 50 tests 398 EUR

Human Echovirus (ECHO) IgM Rapid Test Kit

abx092093-20tests Abbexa 20 tests 272 EUR

Human Toxoplasma (TOX) IgG Rapid Test Kit

abx092098-20tests Abbexa 20 tests 217 EUR

COVID-19 IgG/IgM Rapid Test Kit

UNCOV-20 UnScience 20T/kit 155 EUR

TruStrip RDT Testosterone Rapid Test cards, 10/pk

1880-RDT-10 Alpha Diagnostics 1 pk Ask for price

Influenza Rapid Test Control Pack (3 X 1.5mL)

KZMC033 Zeptometrix 3 X 1.5mL 97.84 EUR

Adenovirus Rapid Test Control Pack (2 X 1.5mL)

KZMC035 Zeptometrix 2 X 1.5mL 97.84 EUR

Rotavirus Rapid Test Control Pack (2 X 1.5mL)

KZMC036 Zeptometrix 2 X 1.5mL 97.84 EUR

Anigen Rapid FIV Ab/FeLV Ag Test Kit

RC12-04-DD Bionote 10 tests/Kit  152.2 EUR

Human Hepatitis A Virus IgG Rapid Test Kit

abx092012-25tests Abbexa 25 tests 425 EUR

Pseudorabies Virus Antibodies Rapid Test Kit (Colloidal gold)

abx092026-50tests Abbexa 50 tests 321 EUR

Canine Parvovirus Antibodies Rapid Test Kit (Colloidal gold)

abx092032-40tests Abbexa 40 tests 356 EUR

Rabies Virus Antibodies Rapid Test Kit (Colloidal gold)

abx092033-40tests Abbexa 40 tests 356 EUR

Clenbuterol-Ractopamine-Salbutamol Rapid Test Kit (Colloidal gold)

abx092039-40tests Abbexa 40 tests 370 EUR

Cattle and Goat Hydatid Antibody Rapid Test Kit

abx092072-40tests Abbexa 40 tests 356 EUR

Avian Influenza H5N1 Virus Antibody Rapid Test Kit

abx092075-40tests Abbexa 40 tests 398 EUR

Human Chlamydia Pneumoniae (CP) IgG Rapid Test Kit

abx092079-20tests Abbexa 20 tests 258 EUR

Human Chlamydia Pneumoniae (CP) IgM Rapid Test Kit

abx092080-20tests Abbexa 20 tests 258 EUR

Human Mycoplasma Pneumoniae (MP) IgG Rapid Test Kit

abx092081-20tests Abbexa 20 tests 258 EUR

Human Mycoplasma Pneumoniae (MP) IgM Rapid Test Kit

abx092082-20tests Abbexa 20 tests 258 EUR

Human Mycobacterium Tuberculosis (MT) IgG Rapid Test Kit

abx092084-20tests Abbexa 20 tests 230 EUR

Human Helicobacter Pylori (HP) IgG Rapid Test Kit

abx092090-20tests Abbexa 20 tests 230 EUR

Human Enterovirus 71 (EV71) IgM Rapid Test Kit

abx092091-20tests Abbexa 20 tests 342 EUR

Human Hantavirus (HV) IgM / IgG Rapid Test Kit

abx092094-20tests Abbexa 20 tests 272 EUR

Human Rubella Virus (RV) IgG Rapid Test Kit

abx092097-20tests Abbexa 20 tests 217 EUR

Human Rabies Virus (HRV) IgG Rapid Test Kit

abx092100-20tests Abbexa 20 tests 342 EUR

Human Treponema Pallidum (TP) Antibody Rapid Test Kit

abx092101-20tests Abbexa 20 tests 258 EUR

Anticyclic citrullinated peptide antibody rapid test (Colloidal Gold)

abx095260-80Units Abbexa 80 Units 1316 EUR

Cardiac Troponin I (cTnI) rapid test (Colloidal Gold)

abx095265-80Units Abbexa 80 Units 1316 EUR

Panbio™ COVID-19 IgG/IgM Rapid Test

ICO-T402 Abbott 25 Tests/Kit 220 EUR

Panbio™ COVID-19 Ag Rapid Test Device

41FK10 Abbott 25 Tests/Kit 96 EUR

At the Oakland, CA and San Francisco, CA study sites, swab samples collected for RT-PCR were transferred to DNA/RNA Shield (Zymo Research, Irvine, CA), stored at room temperature, and shipped overnight at ambient temperature to Curative, Inc. (San Dimas, CA) per the manufacturer’s protocol for laboratory testing. The Curative SARS-CoV-2 Assay, an FDA Emergency Use Approved (EUA) test, was used as the RT-PCR reference method [10].

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