Thermo Fisher Scientific Accula™ Flu A/Flu B Test Kit US

The Accula Flu A/Flu B Test combines RT-PCR accuracy with a portable, palm-sized dock (sold separately) that plugs into a standard outlet, with 10-second dock initiation/start-up, no data entry required, and an elegantly simple workflow.

Supplier:  Thermo Fisher Scientific FAB1100CW

Catalog No. 21-000-134

Description

The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing PCR and lateral flow technologies for the qualitative, visual detection of nucleic acid from influenza A and influenza B viral RNA in clinically collected nasal swab specimens from patients with signs and symptoms of respiratory infection.

Features of the Accula Flu A/Flu B Test include:
• Rapid testing results—RT-PCR Flu A and Flu B results in ~30 minutes
• Streamlined process—CLIA-waived workflow
• Simplified sample collection—use of nasal swab specimens
• Easy—store reagents at room temperature
• Accurate results—sensitivity of Flu A: 97%, Flu B: 94%; specificity of Flu A: 94%, Flu B: 99% compared with a molecular comparator method in a prospective clinical study

The Accula Flu A/Flu B Test is a nucleic acid amplification test (NAAT) for detection of influenza A and influenza B viral RNA in approximately 30 minutes. To perform the test, nasal specimens are added to Nasal Swab Buffer to elute the sample. An aliquot of the eluted sample is then dispensed into an Accula Flu A/Flu B test cassette. The test cassette contains an internal positive and negative control, enzymes, OscAR™ reagents, and a detection strip necessary for the assay.

The four steps of the assay process are:
1. Lysis of the virus
2. Reverse transcription (RT) of viral RNA to cDNA
3. Nucleic acid amplification by PCR
4. Detection

In ~30 minutes, clinicians can identify patients who are Flu A or Flu B positive to allow for prompt treatment.

Intended use
The Accula Flu A/B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patient with signs and symptoms of respiratory infection. Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL-3+ facility is available to receive and culture specimens.

Specifications

• Certifications/Compliance: 510 (k) Class II Medical Device
• CPT Code: 87502QW
• Detectable Analytes: Influenza A, Influenza B
• Format: Kit
• Sensitivity: Flu A: 97%, Flu B: 94%
• For Use With (Application): RT-PCR, Rapid PCR
• Quantity: 25 Tests
• Test Time: ˜30 minutes

• Content And Storage: Store at room temperature.
  
  
• Clia Complexity: Waived
• DoA Calibrators: No
• Sample Type: Nasal Swab
• Type: Flu A/Flu B Assay
• Organism Group: Virus
• Specificity: Flu A: 94%, Flu B: 99%

Safety and Handling

ShelfLife : Up to 18 months