AQ-TOP™ COVID-19 Detection Kit

SEASUN BIOMATERIALS INC.

Run 2-5X more PCR tests per day.

The only EUA authorized kit to use RT-LAMP amplification technology, AQ-TOP™ can reduce your PCR instrument time to results to around 30 minutes. If instrument time reduces your lab’s capacity, this kit can increase the number of daily tests run by up to 5X.

Order

Test Type

Diagnostic PCR
RT-LAMP Amplification

Delivery

7-14 days
Shipped from Korea

FDA Status

EUA Authorized
May 21, 2020

Manufacturer

Seasun Biomaterials Inc. is a Korean company founded in 2012 with ISO 13485, GMP, and CE certifications. It is also certified as a DNA Testing Institution by the Korean CDC. An expert developer of PCR kits, Seasun has developed and sold numerous PCR kits worldwide..

Clinical Studies

100% PPA, 100% NPA (N=120)
Inclusivity analysis: 100% identity for known SARS-CoV-2 strains
In-silico and wet specificity testing: No cross-reactivity

See Instructions for Use for clinical data.

Specifications

Intended Use
Real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in individuals suspected of COVID-19 infection.

Who Can Perform Testing
CLIA-certified laboratories qualified to perform high complexity tests.

Time to Result
Approximately 30 minutes

Sample Types
Oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens, and sputum.

Probe Targets
Two SARS-CoV-2 genome targets in Orf1ab, one target in N.

Limit of Detection
7,000 copies per mL

Controls
Internal Control — Human RNase P gene
Positive Control — Orf1ab and N targets; human RNase P gene
Negative Control — RNase/DNase free distilled water

Components
2X Reaction Buffer — PCR buffer
750µL (2 tubes) Enzyme Mix — Reverse transcriptase, Taq polymerase
100µL Reaction Mix — Primer/Probe mix
400µL (with Internal Control) Positive Control — SARS-CoV-2 target templates
RNase P, 200µL Negative Control — RNase/DNase free distilled water, 200µL

Storage & Handling
Store at –20°C; Use within 3 months of opening; Thaw reagents except Enzyme Mix at room temperature before use; Place all reagents on ice once thawed during entire test procedure; Place Enzyme Mix on ice during entire test procedure; Avoid excessive freeze/thaw cycles; Vortex and spin down reagents before each use.

Sample Collection Kit (Recommended)

Viral Sample Collection Kit by Noble Bio (Cat. No. UTNFS-3B-1)
BDTM Universal Viral Transport System by BD (Cat. No. 220531) for collection and transport of upper respiratory tract samples.
Sputum Collection Container: Sterile Container with Screw Cap by BD (Cat. No. 90004-118) for collection of sputum samples.

RNA Extraction Kit (Required)