SARS-CoV-2 RT-PCR Test Kit

Nucleic Acid Kit
PCR Plates
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SARS-CoV-2 RT-PCR Test Kit

Qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab, nasopharyngeal swab and deep
cough sputum specimens collected from individuals suspected of SARS-CoV-2 by their healthcare provider. *

*Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

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Description

SARS-CoV-2 RT-PCR Test Kit

Qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab, nasopharyngeal swab and deep
cough sputum specimens collected from individuals suspected of SARS-CoV-2 by their healthcare provider. *

*Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

Advantages and performance

Specimens include

Oropharyngeal and nasopharyngeal swabs, and deep cough sputum specimens

Qualitative detection of nucleic acids from SARS-CoV-2

Target Regions

N, E, ORF1ab

High Accuracy

97.93 % (95 % CI: 95.56% – 99.24 %)

Full-process controls with negative, positive and internal controls

Store at – 20 ± 5 ºC

CE Marked

Promotor® SARS-CoV-2 RT-PCR Test Kit

Product Specifications

Feature Specification
Technology Real-Time reverse transcription polymerase chain reaction (rRT-PCR)
Target Region N, E, ORF1ab
Specimen Type Oropharyngeal swab, nasopharyngeal swab and deep cough sputum
Internal Control Yes
Minimum Sample Volume 200 μL
Test Duration 90 minutes
Limit of Detection 500 copies/mL
Precision of In-batch and batch (CV) < 5 %
Positive Percent Agreement 97.46 % (95 % CI: 92.75 % – 99.47 %)
Negative Percent Agreement 98.26 % (95 % CI: 94.99 % – 99.64 %)
Accuracy 97.93 % (95 % CI: 95.56% – 99.24 %)
Storage Temperature – 20 ± 5 ºC
Package Size 32 Tests/Kit

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