23-111-414
Germaine™ Laboratories Celltrion DiaTrust™ COVID-19 Ag Rapid Test, 25 Pk.
Manufacturer: Germaine™ Laboratories
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Buffer
0.3 mL of Extraction Buffer
Clia Complexity
Waived (FDA, EUA)
Sensitivity
93.33% (28/30) (95% CI: 78.7%-98.2%)
Includes
Test devices packaged individually in aluminum pouch, disposable test tube with buffer, filter cap, sterilized swabs, quick reference instruction, positive and negative control swabs
Specificity
99.03% (102/103) (95% CI: 94.7%-99.8%)
CE Marker
Yes
Detectable Analytes
SARS-CoV-2
Disposable
Single-use
Quantity
25 Pk.
Test Time
15 min
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Description
- The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a lateral flow immunoassay test designed to detect antigen from the SARS-CoV-2 in human nasopharyngeal swab specimens from patients who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests
- The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is validated for use from direct specimens testing without transport media, and does not differentiate between SARS-CoV and SARS-CoV-2
- This Rapid Test is intended for use by medical professionals or trained operators who are proficient in performing tests, trained clinical laboratory personnel, or individuals trained in POC settings
- Variants are anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation
- In the United States, the Celltrion DiaTrust™ COVID-19 Ag Rapid Test is only for use under the Food and Drug Administration's Emergency Use Authorization
- No Additional Instrument Required Read Results In 15 min Nasopharyngeal Swab (NPS) Detection of Antigen from SARS-CoV-2 Prospective Study Clinical Sensitivity: 93.33% (28/30) (95% CI: 78.7-98.2%) Clinical Specificity: 99.03% (102/103) (95% CI: 94.7-99.8%) 12 Month Shelf Life Manufactured in Republic of Korea (South Korea)
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Buffer: 0.3 mL of Extraction Buffer
Clia Complexity: Waived (FDA, EUA)
Sensitivity: 93.33% (28/30) (95% CI: 78.7%-98.2%)
Includes: Test devices packaged individually in aluminum pouch, disposable test tube with buffer, filter cap, sterilized swabs, quick reference instruction, positive and negative control swabs
Specificity: 99.03% (102/103) (95% CI: 94.7%-99.8%)
CE Marker: Yes
Detectable Analytes: SARS-CoV-2
Disposable: Single-use
Quantity: 25 Pk.
Test Time: 15 min
Buffer:
0.3 mL of Extraction Buffer
Clia Complexity:
Waived (FDA, EUA)
Sensitivity:
93.33% (28/30) (95% CI: 78.7%-98.2%)
Includes:
Test devices packaged individually in aluminum pouch, disposable test tube with buffer, filter cap, sterilized swabs, quick reference instruction, positive and negative control swabs
Specificity:
99.03% (102/103) (95% CI: 94.7%-99.8%)
CE Marker:
Yes
Detectable Analytes:
SARS-CoV-2
Disposable:
Single-use
Quantity:
25 Pk.
Test Time:
15 min
Buffer: __
Clia Complexity: Waived
Sensitivity: 0.97
Includes: Test Devices, Extraction Buffers and Tubes with Caps, Package Insert
Specificity: 0.98
CE Marker: Yes
Detectable Analytes: Respiratory Syncytial Virus (RSV)
Disposable: __
Quantity: 30/Kit
Test Time: 15 minutes
Buffer:
__
Clia Complexity:
Waived
Sensitivity:
0.97
Includes:
Test Devices, Extraction Buffers and Tubes with Caps, Package Insert
Specificity:
0.98
CE Marker:
Yes
Detectable Analytes:
Respiratory Syncytial Virus (RSV)
Disposable:
__
Quantity:
30/Kit
Test Time:
15 minutes
Buffer: __
Clia Complexity: Not Applicable
Sensitivity: 10 ng/mL
Includes: 25 DipSticks per Kit, package insert.
Specificity: __
CE Marker: __
Detectable Analytes: Fentanyl (FEN)
Disposable: Single-use
Quantity: __
Test Time: 5 min.
Buffer:
__
Clia Complexity:
Not Applicable
Sensitivity:
10 ng/mL
Includes:
25 DipSticks per Kit, package insert.
Specificity:
__
CE Marker:
__
Detectable Analytes:
Fentanyl (FEN)
Disposable:
Single-use
Quantity:
__
Test Time:
5 min.
Buffer: __
Clia Complexity: Waived
Sensitivity: Substantial equivalent to the leading national brand
Includes: __
Specificity: __
CE Marker: No
Detectable Analytes: Glucose, Protein, Ketone, pH, Blood
Disposable: Single-use
Quantity: __
Test Time: __
Buffer:
__
Clia Complexity:
Waived
Sensitivity:
Substantial equivalent to the leading national brand
Includes:
__
Specificity:
__
CE Marker:
No
Detectable Analytes:
Glucose, Protein, Ketone, pH, Blood
Disposable:
Single-use
Quantity:
__
Test Time:
__