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The RADI COVID-19 Detection Kit is intended for the presumptive qualitative detection of specific nucleic acid sequences from the genome of the SARS-CoV-2 S gene and RdRP gene from the upper respiratory specimens such as Nasopharyngeal swab, Oropharyngeal swab.
| RADI COVID-19 Detection Kit | |
|---|---|
| Intended use | Qualitative detection of COVID-19 |
| Specimen type | RNA extracted from Nasopharyngeal and/or Oropharyngeal swab |
| Target | S gene, RdRP gene |
| Product contents |
COVID-19 Positive Control (Red) COVID-19 Extraction Control (Red, Yellow sticker on top) 3X RT MasterMix (Yellow) COVID-19 Primer & Probe Mixture (Brown) RNase Free Water (Blue) |
| Shelf life | 8 months |
| Storage condition |
-25℃ ~ -15℃ |
* Simplified Procedure when make mixture
(Number of tubes minimized)!
| KHMedical Ref | Product Name |
| RV008 | RADI COVID-19 Detection Kit |
| MP002 | RADI PREP Swab and Stool DNA/RNA Kit |
| KM001 | RADI PREP Plus |
In order to determine limit of detection (LoD) of RADI COVID-19 Detection kit, a tentative LoD is determined with several diluted concentrations using synthesized RNA by in vitro transcription in 5 replicates. After fixing a tentative LoD is the claimed LoD was determined with 20 replicates of diluted concentrations spanning tentative LoD.
Final LoD of S gene : 0.66 copies/㎕
| Target | copies/㎕ | Mean Ct | Result in agreement |
Percent agreement |
| S gene | 2.33 | 37.29 | 20/20 | 100% |
| 2.00 | 37.35 | 20/20 | 100% | |
| 0.66 | 38.24 | 20/20 | 100% | |
| 0.5 | 38.27 | 17/20 | 85% |
Final LoD of RdRP gene : 0.66 copies/㎕
| Target | copies/㎕ | Mean Ct | Result in agreement |
Percent agreement |
| RdRP gene | 2.33 | 36.93 | 20/20 | 100% |
| 2.00 | 37.01 | 20/20 | 100% | |
| 0.66 | 38.16 | 20/20 | 100% | |
| 0.5 | 38.49 | 16/20 | 80% |
RADI COVID-19 Detection Kit was tested with 63 potential microorganism (including pooled human nasal wash sample).
It was verified that 63 kinds of potential cross-reacting microorganism did not cross-react with any of 63 microorganisms.
RADI COVID-19 Detection Kit was tested with 14 potentially interfering endogenous or exogenous substances in negative clinical matrix with the absence or presence of SARS-CoV-2 (3X LoD).
And it was verified that 14 kinds of potential interfering substances did not have an impact on interference.
The clinical performance of RADI COVID-19 Detection Kit has been evaluated in different countries from different continents.
A total number of 764 samples have been evaluated, and 366 of them were SARS-CoV-2 positive and the rest were negative samples.
Performance in individual site
| No | Site | Result for Sensitivity | Result for Specificity |
| 1 | Switzerland | 100% (50/50) | 100% (100/100) |
| 2 | USA | 100% (111/111) | 100% (96/96) |
| 3 | Saudi Arabia | 100% (31/31) | 100% (24/24) |
| 4 | Uganda | 94% (29/31) | 100% (45/45) |
| 5 | Brazil | 100% (14/14) | 100% (8/8) |
| 6 | Netherland | 92% (12/13) | 100% (11/11) |
| 7 | Haiti | 100% (6/6) | 100% (5/5) |
| 8 | South Korea | 99% (109/110) | 100% (109/109) |
Comprehensive Performance from all sites
| Comprehensive Sensitivity% | Comprehensive Specificity% |
| 98.9% (362/366) (95CI% : 97.2 – 99.6) |
100.0% (398/398) (95CI% : 99.0 – 100.0) |
RADI COVID-19 Detection Kit’s Primer & Probe design could detect up to 10 copies/rxn compared to
WHO Primer & Probe which detect up to 10² copies/rxn for E gene and 10³ copies/rxn for RdRP gene
| Copies / rxn | S gene | RdRP gene | ||
| 106 | 21.06 | 21.2 | 21.46 | 21.63 |
| 105 | 25.05 | 24.97 | 25.01 | 24.65 |
| 104 | 28.99 | 29.22 | 28.22 | 28.29 |
| 103 | 32.47 | 32.62 | 31.96 | 31.81 |
| 102 | 36.51 | 36.41 | 36.4 | 35.18 |
| 101 | 39.95 | 39.66 | 39.18 | 38.05 |
| E gene | RdRP gene | ||
| 23.24 | 22.72 | 24.75 | 24.78 |
| 26.48 | 26.34 | 28.17 | 28.12 |
| 29.90 | 29.88 | 31.44 | 31.31 |
| 32.48 | 32.26 | 34.61 | 33.72 |
| 35.69 | 36.76 | N/A | N/A |
| N/A | N/A | N/A | N/A |
S gene
RdRP gene
E gene
RdRP gene