Evaluation of the INDICAID COVID-19 Rapid Antigen Test in Symptomatic Populations and Asymptomatic Community Testing

Because the COVID-19 pandemic progresses, there may be an rising want for fast, accessible assays for SARS-CoV-2 detection. We current a medical analysis and real-world implementation of the INDICAID COVID-19 fast antigen check (INDICAID fast check).

A multisite medical analysis of the INDICAID fast check utilizing prospectively collected nasal (bilateral anterior) swab samples from symptomatic topics was carried out. The INDICAID fast check demonstrated a constructive % settlement (PPA) and adverse % settlement (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, in comparison with laboratory-based reverse transcriptase PCR (RT-PCR) utilizing nasal specimens.

 

The INDICAID fast check was then applied at COVID-19 outbreak screening facilities in Hong Kong as a part of a testing algorithm (termed “dual-track”) to display screen asymptomatic people for prioritization for confirmatory RT-PCR testing. In a single strategy, preliminary constructive INDICAID fast check outcomes triggered expedited processing for laboratory-based RT-PCR, lowering the common time to confirmatory end result from 10.85 h to 7.Zero h.

 

In a second strategy, preliminary constructive outcomes triggered subsequent testing with an onsite fast RT-PCR, lowering the common time to confirmatory end result to 0.84 h. In 22,994 asymptomatic sufferers, the INDICAID fast check 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%) in comparison with laboratory-based RT-PCR utilizing mixed nasal/oropharyngeal specimens. The INDICAID fast check has glorious efficiency in comparison with laboratory-based RT-PCR testing and, when utilized in tandem with RT-PCR, reduces the time to confirmatory constructive end result.

 

IMPORTANCE Laboratory-based RT-PCR, the present gold normal for COVID-19 testing, can require a turnaround time of 24 to 48 h from pattern assortment to end result. The delayed time to end result limits the effectiveness of centralized RT-PCR testing to cut back transmission and stem potential outbreaks. To handle this, we performed an intensive analysis of the INDICAID COVID-19 fast antigen check, a 20-minute fast antigen check, in each symptomatic and asymptomatic populations.

 

The INDICAID fast check demonstrated excessive sensitivity and specificity with RT-PCR because the comparator technique. A dual-track testing algorithm was additionally evaluated using the INDICAID fast check to display screen for preliminary constructive sufferers, whose samples had been then prioritized for RT-PCR testing. The twin-track technique demonstrated important enhancements in expediting the reporting of constructive RT-PCR check outcomes in comparison with normal RT-PCR testing with out prioritization, providing an improved technique for neighborhood testing and controlling SARS-CoV-2 outbreaks.

The INDICAID COVID-19 Fast Antigen Check (CE-IVD) is a lateral circulate immunoassay designed for the qualitative detection of SARS-CoV-2 antigens in direct nasal swab samples.

Antigens are current within the SARS-CoV-2 virus, and may sure with particular antibodies.

When a virus enters a human physique and begins to multiply, the physique begins to react to the viral antigens, probably leading to signs.

The INDICAID COVID-19 Fast Antigen Check Fast detects antigens from SARS-CoV-2 virus and can be utilized for COVID-19 screening throughout lively an infection

 

COVID Fast Antigen Check Kits – IndicAid – Field of 25 Checks

Beginning as little as $9.99 / check

TIERED PRICING

  • Tier 1: By Bins: 1 – 19 packing containers: $10.99/check (25 checks per field)
  • Tier 2: By Cartons: 1-19 Cartons: $10.49/check (25 checks per field, 20 packing containers per carton)
  • Tier 3: By Pallets: 1+ Pallets: $9.99/check (25 checks per field, 400 packing containers per pallet)

NOTE 

  • To be used below an Emergency Use Authorization (EUA) solely all through the COVID-19 declaration justifying the emergency use of in vitro diagnostics (IVD), until it’s terminated or revoked by the FDA (after which the check could now not be used)
  • CLIA quantity is required from all Purchasers of the checks

Please choose your pricing tier

  • Bins: ordering 1 – 19 packing containers
  • Cartons: ordering 20 – 380 packing containers
  • Pallets: If you might want to order greater than 400 packing containers please contact us

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