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.

Free Chlorine Reagent set (25 tests)

HI-701-25 Scientific Laboratory Supplies PK25 7.58 EUR

Total Chlorine Reagent set (25 tests)

HI-711-25 Scientific Laboratory Supplies PK25 11.67 EUR

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

PCT-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 Human Serum Amyloid A (SAA) Rapid Test cards, 25 tests/pack

SAA-RDT-25 Alpha Diagnostics 1 pack 351.6 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

Slide Box Blue 25 Slides

MIC3562 Scientific Laboratory Supplies EACH 19.13 EUR

Slide Box Green 25 Slides

MIC3564 Scientific Laboratory Supplies EACH 19.13 EUR

Slide Box Red 25 Slides

MIC3566 Scientific Laboratory Supplies EACH 19.13 EUR

Slide Box White 25 Slides

MIC3570 Scientific Laboratory Supplies EACH 19.13 EUR

Slide Box 25 Slide Polystyrene

MIC4066 Scientific Laboratory Supplies EACH 12.54 EUR

MTBK_20640-25

AR02-P0011-25 Abfrontier 25ug 567.6 EUR

Economy Slide box 25 Place BLUE

MIC3580 Scientific Laboratory Supplies EACH 13.32 EUR

Economy Slide box 25 Place RED

MIC3582 Scientific Laboratory Supplies EACH 13.32 EUR

Economy Slide box 25 Place WHITE

MIC3584 Scientific Laboratory Supplies EACH 14.02 EUR

Slide Box White for 25 Slides

MIC4000 Scientific Laboratory Supplies EACH 9.69 EUR

Microscope Slide Box 25 ULT safe

MIC4092 Scientific Laboratory Supplies EACH 17.62 EUR

PC Freezer Box 25-Place 76x76x27mm

ARG1728 Scientific Laboratory Supplies PK4 71.82 EUR

Storage Box 25 Tubes 2 inch

E0030140583 Scientific Laboratory Supplies PK2 20.75 EUR

Storage Box 25 Tubes 3 inch

E0030140613 Scientific Laboratory Supplies PK2 20.24 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

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

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

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

A1039-25 ApexBio 25 mg 606 EUR

Express Plasmid Midiprep Kit (25 min)

K1323-25 Biovision each 561.6 EUR

Express Plasmid Maxiprep Kit (25 min)

K1324-25 Biovision each 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

Storage box 5mL tube 25 pl blue

RAC2006 Scientific Laboratory Supplies PK18 180.12 EUR

Storage box 5mL tube 25 pl green

RAC2008 Scientific Laboratory Supplies PK18 180.12 EUR

Storage box 5mL tube 25 pl pink

RAC2010 Scientific Laboratory Supplies PK18 180.12 EUR

Storage box 5mL tube 25 pl yello

RAC2012 Scientific Laboratory Supplies PK18 180.12 EUR

PREMIUM SLIDE BOX 25 PLACE FOAM LININ

HS15989R Scientific Laboratory Supplies EACH 16.99 EUR

Eye Wash Pods 20ml Box of 25

SAF1380 Scientific Laboratory Supplies PK25 9.87 EUR

Box for 25 microscope slides purple colour

DD49719 Scientific Laboratory Supplies EACH 15.28 EUR

Box for 25 microscope slides orange colour

DD49720 Scientific Laboratory Supplies EACH 15.28 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.