Evaluation of the INDICAID COVID-19 Rapid Antigen Test in Symptomatic Populations

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, Rapid antigen test procedure offering an improved strategy for community testing and controlling SARS-CoV-2 outbreaks.

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 (2).
  • The current gold standard for detecting SARS-CoV-2 is reverse transcriptase PCR (RT-PCR) (3). While RT-PCR can detect nucleic acids from SARS-CoV-2 with high sensitivity, RT-PCR requires equipment and special training and can take days for results to be available following sample collection (4).
  • Due to the 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 (5, 6).
  • 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 INDICAID COVID-19 rapid antigen test (INDICAID rapid test) by PHASE Scientific International Ltd. A prospective multisite 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.

Prospective multisite clinical evaluation of the INDICAID COVID-19 rapid antigen test.

 In total, 83 participants with at least two COVID-19 symptoms were enrolled at the San Francisco, CA and Oakland, CA sites. Two participants were excluded from the analysis due to lost samples during transport for RT-PCR. Of the 81 participant specimens analyzed, 44.4% were from female participants (Table S1), with a median age of 32 years (interquartile range [IQR], 25, 44). The most frequently reported symptoms were muscle/body ache (61.7%), congestion/runny nose (60.5%), fatigue (56.8%), and headache (53.1%). The breakdown of duration of symptoms was 1 to 2 days in 37 participants (45.7%), 3 to 4 days in 38 participants (46.9%), and 5 days in 6 participants (7.4%).

San Fernando population characteristics.

In total, 270 participants with at least one COVID-19 symptom were enrolled at the San Fernando, CA site. Two participants were excluded from the analysis due to lost or spilled samples during transport for RT-PCR. Of the 268 participant specimens analyzed, 52.6% were from female participants (Table S2), and the median age was 35 years (IQR, 24, 50). The most frequently reported symptoms were sore throat (60.8%), headache (60.1%), congestion/runny nose (59.0%), and cough (54.9%). The distribution of duration of symptoms was 1 to 2 days in 109 participants (40.7%), 3 to 4 days in 127 participants (47.4%), and 5 days in 32 participants (11.9%).

Performance of the INDICAID COVID-19 rapid antigen test in symptomatic patients.

Of the total 329 participant specimens included in the analyses, 75 tested positive with the comparator laboratory-based RT-PCR test. The mean cycle threshold value was 20.79 ± 6.39.

The INDICAID rapid test demonstrated a PPA of 85.3% (95% confidence interval [95% CI], 75.6% to 91.6%) and an NPA of 94.9% (95% CI, 91.6% to 96.9%) when sample collection was conducted by a health care professional. There was a total of 11 false-negative INDICAID results that were not concordant with RT-PCR results; the mean threshold cycle (CT) value of the false-negative INDICAID specimens was 32.56 ± 4.59.

 

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.

TruStrip RDT Human Procalcitonin (PCT) Rapid Test cards, 25 tests/pack

PCT-RDT-25 Alpha Diagnostics 1 pack 351.6 EUR

TruStrip RDT Human Serum Amyloid A (SAA) Rapid Test cards, 25 tests/pack

SAA-RDT-25 Alpha Diagnostics 1 pack 351.6 EUR

Human Rena-strip Kit, 25 tests

H-RENA-LF-025 BioAssayWorks 25 tests 617.3 EUR

Rat Rena-strip Kit, 25 tests

R-RENA-LF-025 BioAssayWorks 25 tests 617.3 EUR

TruStrip RDT 5-minute Horse meat detection/adulteration rapid test cards, 25 tests/pk

RDT-6050H-25 Alpha Diagnostics 1 pk 351.6 EUR

MTBK_20640-25

AR02-P0011-25 Abfrontier 25ug 567.6 EUR

Rv0351 (GrpE)-25

AR02-P0003-25 Abfrontier 25ug 151.2 EUR

Rv1009 (RpfB)-25

AR02-P0006-25 Abfrontier 25ug 567.6 EUR

Rv2450c (RpfE)-25

AR02-P0007-25 Abfrontier 25ug 567.6 EUR

Rv3875 (esxA)-25

AR02-P0008-25 Abfrontier 25ug 567.6 EUR

Rv2031c(HspX)-25

AR02-P0009-25 Abfrontier 25ug 567.6 EUR

Rv3131 (NfnB)-25

AR02-P0010-25 Abfrontier 25ug 567.6 EUR

Cardboard freezer box, hinged lid, insert for 25 snap-cap 5ml tubes, 5.25 x 5.25 x 3 inches

C2580-25 MTC Bio 5/pack 76.04 EUR

26795 25 CLOSURE NTRL 25MM

26795-25 CORNING 50/pk 115.2 EUR

AXYGEN® 25-WELL COMB FOR USE WITH 10 CM GEL BOX, 1.0 MM THICKNESS

HGB10-25-1 CORNING 1/pk 70.8 EUR

AXYGEN® 25-WELL COMB FOR USE WITH 10 CM GEL BOX, 2.0 MM THICKNESS

HGB10-25-2 CORNING 1/pk 70.8 EUR

AXYGEN® 25-WELL COMB FOR USE WITH 20 CM GEL BOX, 1.0 MM THICKNESS

HGB20-25-1 CORNING 1/pk 82.8 EUR

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

800-100-RDT-25 Alpha Diagnostics 1 pk 489.6 EUR

Mouse IL-25 ELISA Kit, 96 tests, Quantitative

MIL-025-170 Alpha Diagnostics 1 kit 607.2 EUR

Nori® Human Myoglobin POCT Systems-25 Tests

GR220006 Genorise Scientific 25 Tests 358.8 EUR

Nori® Human Myeloperoxidase POCT Systems-25 Tests

GR220007 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human CRP POCT Systems-25 Tests

GR220008 Genorise Scientific 25 Tests 358.8 EUR

Nori® Human GPBB POCT Systems-25 Tests

GR220009 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human ANP POCT Systems-25 Tests

GR220010 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human MyBPC3 POCT Systems-25 Tests

GR220012 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human PAPPA POCT Systems-25 Tests

GR220014 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human Copeptin POCT Systems-25 Tests

GR220015 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human ST2 POCT Systems-25 Tests

GR220016 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human MMP2 POCT Systems-25 Tests

GR220017 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human sPLA2 POCT Systems-25 Tests

GR220018 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine Myoglobin POCT Systems-25 Tests

GR221006 Genorise Scientific 25 Tests 358.8 EUR

Nori® Canine Myeloperoxidase POCT Systems-25 Tests

GR221007 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine CRP POCT Systems-25 Tests

GR221008 Genorise Scientific 25 Tests 358.8 EUR

Nori® Canine GPBB POCT Systems-25 Tests

GR221009 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine ANP POCT Systems-25 Tests

GR221010 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine MyBPC3 POCT Systems-25 Tests

GR221012 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine PAPPA POCT Systems-25 Tests

GR221014 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine Copeptin POCT Systems-25 Tests

GR221015 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine ST2 POCT Systems-25 Tests

GR221016 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine MMP2 POCT Systems-25 Tests

GR221017 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine sPLA2 POCT Systems-25 Tests

GR221018 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline Myoglobin POCT Systems-25 Tests

GR222006 Genorise Scientific 25 Tests 358.8 EUR

Nori® Feline Myeloperoxidase POCT Systems-25 Tests

GR222007 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline CRP POCT Systems-25 Tests

GR222008 Genorise Scientific 25 Tests 358.8 EUR

Nori® Feline GPBB POCT Systems-25 Tests

GR222009 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline ANP POCT Systems-25 Tests

GR222010 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline MyBPC3 POCT Systems-25 Tests

GR222012 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline PAPPA POCT Systems-25 Tests

GR222014 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline Copeptin POCT Systems-25 Tests

GR222015 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline ST2 POCT Systems-25 Tests

GR222016 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline MMP2 POCT Systems-25 Tests

GR222017 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline sPLA2 POCT Systems-25 Tests

GR222018 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine Myoglobin POCT Systems-25 Tests

GR223006 Genorise Scientific 25 Tests 358.8 EUR

Nori® Equine Myeloperoxidase POCT Systems-25 Tests

GR223007 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine CRP POCT Systems-25 Tests

GR223008 Genorise Scientific 25 Tests 358.8 EUR

Nori® Equine GPBB POCT Systems-25 Tests

GR223009 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine ANP POCT Systems-25 Tests

GR223010 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine MyBPC3 POCT Systems-25 Tests

GR223012 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine PAPPA POCT Systems-25 Tests

GR223014 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine Copeptin POCT Systems-25 Tests

GR223015 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine ST2 POCT Systems-25 Tests

GR223016 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine MMP2 POCT Systems-25 Tests

GR223017 Genorise Scientific 25 Tests 741.6 EUR

Nori® Equine sPLA2 POCT Systems-25 Tests

GR223018 Genorise Scientific 25 Tests 741.6 EUR

Amyloid Beta-peptide (25-35) (human)

A1039-25 ApexBio 25 mg 606 EUR

Express Plasmid Midiprep Kit (25 min)

K1323-25 Biovision 561.6 EUR

Express Plasmid Maxiprep Kit (25 min)

K1324-25 Biovision 732 EUR

2.5x14 cellogel 250µ (25)

EHCA1200-ST06-25 Consort ea 45.6 EUR

2.5x14 cellogel 200µ (25)

EHCA1200-ST07-25 Consort ea 45.6 EUR

2.5x17 cellogel 250µ (25)

EHCA1200-ST11-25 Consort ea 49.2 EUR

2.5x17 cellogel 200µ (25)

EHCA1200-ST12-25 Consort ea 49.2 EUR

5.7x13 cellogel 250µ (25)

EHCA1200-ST29U-25 Consort ea 72 EUR

5.7x14 cellogel 250µ (25)

EHCA1200-ST31-25 Consort ea 63.6 EUR

5.7x14 cellogel 200µ (25)

EHCA1200-ST32-25 Consort ea 63.6 EUR

5.7x14 cellogel 500µ (25)

EHCA1200-ST34-25 Consort ea 72 EUR

Rv2769c (PE27 protein)-25

AR02-P0001-25 Abfrontier 25ug 243.6 EUR

25-place microscope slide box (for 75 x 25 mm slides)

PO202 FD Neurotechnologies each 73.2 EUR

F-Box Only Protein 25 (FBXO25) Antibody

20-abx318182 Abbexa
  • 493.20 EUR
  • 2214.00 EUR
  • 718.80 EUR
  • 218.40 EUR
  • 360.00 EUR
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Agouti-related Protein (AGRP) (25-82), human

A1134-25 ApexBio 25 mg 1813.2 EUR

DiaEasy? Dialyzer (3 ml) MWCO 25 kDa

K1015-25 Biovision 588 EUR

DiaEasy? Dialyzer (250 µl) MWCO 25 kDa

K1022-25 Biovision 418.8 EUR

DiagNano Fluorophore Labeled Gold Nanoparticles, 25 nm

GFL-25 Creative Diagnostics 1 mL 1263.6 EUR

Nori® Human H-FABP POCT Systems-25 Tests

GR220004 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human NT-proBNP POCT Systems-25 Tests

GR220005 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human Lp-PLA2 POCT Systems-25 Tests

GR220011 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human GDF-15 POCT Systems-25 Tests

GR220013 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human Endothelin-1 POCT Systems-25 Tests

GR220019 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human Galectin-3 POCT Systems-25 Tests

GR220020 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human IL-6 POCT Systems-25 Tests

GR220022 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human TNF-alpha POCT Systems-25 Tests

GR220023 Genorise Scientific 25 Tests 741.6 EUR

Nori® Human Interferon Gamma POCT Systems-25 Tests

GR220024 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine H-FABP POCT Systems-25 Tests

GR221004 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine NT-proBNP POCT Systems-25 Tests

GR221005 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine Lp-PLA2 POCT Systems-25 Tests

GR221011 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine GDF-15 POCT Systems-25 Tests

GR221013 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine Endothelin-1 POCT Systems-25 Tests

GR221019 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine Galectin-3 POCT Systems-25 Tests

GR221020 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine IL-6 POCT Systems-25 Tests

GR221022 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine TNF-alpha POCT Systems-25 Tests

GR221023 Genorise Scientific 25 Tests 741.6 EUR

Nori® Canine Interferon Gamma POCT Systems-25 Tests

GR221024 Genorise Scientific 25 Tests 741.6 EUR

Nori® Feline H-FABP POCT Systems-25 Tests

GR222004 Genorise Scientific 25 Tests 741.6 EUR

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.

Leave a Reply

Your email address will not be published.