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ACCULA SARS
Cov-2 Test

ACCULA SARS COV-2 Test

The AcculaTM System from Thermo Fisher Scientific is a rapid diagnostic platform that combines the accuracy of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays.

The AcculaTM SARS-CoV-2 Test has received an Emergency Use Authorization (EUA) from the FDA for the detection of SARS-CoV-2 in Clinical Laboratory Improvement Amendments (CLIA)—waived environments. Designed for use with the palm-sized AcculaT" Dock, the Accula SARS-CoV-2 Test provides reliable, qualitative results in approximately 30 minutes.

Gold-Standard PCR Technology
Simple Sample Collection
Fast Results
Easy Storage
Compact Design

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Key Features

 
 
RT PCR Test in 30 Minutes
Compact Plam Size Model
IReceived Emergency Use Authorization (EUA)
from the US FDA in CLIA-waived environment
Simple Sample Collection
Easy Storage at room temperature

30 Mins For Accurate, accessible, and actionable results

 

Technology

OSCillating Amplification Reaction (OscarTm), proprietary PCR technology, enables rapid exponential amplification while reducing overall thermocycling times.

Performance

Prospective Clinical Study

Accula SARS-CoV-2 Test

Comparator's assay

Positive

Negative

Total

Positive

4

0

4

Negative

0

48

48

Total

0

48

52

PPA

100% (95% CI: 39.76%-100%)

NPA

100% (95% CI: 92.60%-100%)

Overall Percent Agreement (OPA)

100% (95% Cl: 93.15%-100%)


Nasal swab samples were collected from 52 pediatric patients at a drive-through collection site. Testing was performed with the Accula SARS-CoV-2 Test and the comparator method, an EUA-authorized RT-PCR SARS-CoV-2 test.

Ordering Information

Prodcuts

Quantity

Cat. No.

RT-PCR Accula SARS-CoV-2 Test

1 Kit

COV41000

Accula Dock

1 Dock

D2000

Accula SARS-CoV-2 Control Kit

9 Controls

COV4100-1

Summary of limit of detection (LoD) confirmation result using the FDA SARS-CoV-2 reference panel

Reference materials provided by FDA

Specimen type

Product LoD

Cross-reactivity

SARS-CoV-2

Nasal swab

475 NDU/mL

N/A

MERS-CoV

N/A

N/A


The evaluation of sensitivity and MERS-CoV cross-reactivity was performed using reference material, blinded samples, and a standard protocol provided by the FDA. The study included a range finding study and a confirmation study for LoD. Blinded sample testing was used to establish specificity and to corroborate the LoD. Testing was performed using the Accula SARS-CoV-2 Test with the Accula Dock.

NDU/mL = RNA NAAT detectable units/mL
N/A: not applicable
N/D: not detected

The AcculaTM System from Thermo Fisher Scientific is a rapid diagnostic platform that combines the accuracy of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays.

For Product Inquiry :- support.covidebb@txtechnology.co.in or For more information, Get in Touch
Accula SARS Cov-2 Test
Accula System SARS Cov-2 Test Sample
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Accula Kit Contents
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