EVALUATION RESULTS OF NUCLEIC ACID EXTRACTION KITS
Last updated: 13 May 2022

Nucleic acid amplification tests for the detection of infectious disease pathogens, require good quality nucleic acid material as a prerequisite. The quality of isolated nucleic acid from clinical specimens directly affects quality of the diagnostic test result. Various technologies are currently available to extract/isolate nucleic acids from clinical specimens. For the purpose of laboratory diagnosis of COVID-19, the ribonucleic acid is extracted primarily from respiratory specimens such as nasopharyngeal and oropharyngeal swabs.

Evaluation of nucleic acid extraction kits is crucial in ensuring that the yield of nucleic acid material is of sufficient quantity, quality, purity, and integrity, suitable for the assays to be used, such as Real-Time PCR detection of SARS-CoV-2 virus.

Given that the nucleic acid extraction kit performance evaluation performed here is specifically intended to assess the applicability for SARS-CoV-2 detection by Real-Time PCR, the evaluation involves an estimation of the concordance of SARS-CoV-2 Real-Time PCR results generated from the nucleic acid extraction yield of a reference nucleic acid extraction method and the method/kit under evaluation.

A verification panel, comprising of  a set of clinical specimens of known reactivity (known SARS-CoV-2 PCR result) is used, where each specimen is extracted in parallel using the two methods, to facilitate comparative evaluation. Result concordance between the two extraction methods (reference method vs the method under evaluation) is then estimated, using Real-Time PCR assays of established and acceptable performance characteristics.

Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.

results
# Nucleic Acid Extraction Kit Manufacturer Catalog number Concordance Rate Date Performed
Sansure Biotech 2019-nCoV XAbt Multiple Real-time PCR kit A*Star Fortitude Kit 2.0 BGI Real-time Fluorescent RT-PCR kit MirXes Fortitude 2.1 STAT-NAT® COVID-19 MULTI
1 QIAamp Viral RNA mini kit Qiagen 50preps/Cat. No. 52904
250preps/Cat. No. 52906
100% 100% 100% 100% April 18, 2020
2 Purelink Viral RNA/DNA kit Invitrogen Corp. 50preps/Cat. No. 12280050 100% 100% 100% 100% April 18, 2020
3 Monarch Total RNA Miniprep kit New England Biolabs 50preps/Cat. No. T2010S 100% 100% 100% 100% April 18, 2020
4 Genejet Viral RNA/DNA Kit Thermo Fisher Scientific 50preps/Cat. No. K0821 100% 100% 100% 100% May 13, 2020
5 NucleoSpin Dx Virus Macherey-Nagel GmbH & Co. 50T/Cat. No. 740895.50 100% 100% 100% 100% May 13, 2020
6 NucleoSpin Virus Macherey-Nagel GmbH & Co. 10preps/Cat. No. 740983.10
50preps/Cat. No. 740983.50
250preps/Cat. No. 740983.250
100% 100% 100% 100% April 27, 2020
7 GenAmplify Viral RNA Purification kit Manila HealthTek, Inc., Philippines 50T/Cat. No. GA-RNA050 100% 100% 100% May 5, 2020
8 High Pure Viral RNA Roche Diagnostics 100%
9 GeneAid Viral Nucleic Acid Extraction kit II Geneaid Biotec Ltd. 50preps/Cat. No. VR050 96.20% 96.20% 92.30% May 19, 2020
10 Biospin Virus DNA/RNA Extraction kit Hangzhou Bioer Technology Co. Ltd. 50T/Cat. no. BSC77SI
100T/Cat. no. BSC77MI
100% 100% 96% 100% May 19, 2020
11 RNA/DNA Purification kit (Spin Column) Guangzhou DaTe Bioengineering Technology, Co. Ltd. 48T/Cat. no. DTTQ00101 100% 100% 93% 100% May 25, 2020
12 ReliaPrep™ Viral Total Nucleic Acid Purification Kit Promega Corporation 250preps/Cat. no. AX4820 100% 100% 100% 100% May 25, 2020
13 DIAKEY REALkey Viral DNA/RNA Prep Kit Shin Jin Medics Inc 100preps/Cat. no. DP01 100% 100% 100% 100% April 28, 2020
14 (XABT) XABT Nucleic Acid Extraction Kit Beijing Applied Biological Technologies Co. Ltd. (XABT) 48 preps/ Cat. # CN80334 100% April 16, 2020
15 BeaverBeads™ Viral DNA/RNA Kit Beaver Biomedical Engineering Co. Ltd. 20 preps/ Cat no. 70406-20 84.30% May 6, 2020
16 MGI Nucleic Acid Extraction Kit Wuhan MGI Tech Co., Ltd. (Wuhan, China) 1728 preps/ Item no. 1000020261 100% 100% May 18, 2020
17 Mag-bind RNA Extraction kit Maccura Biotechnology Co. Ltd. 32preps/Cat. No. GN7101907
48preps/Cat. No. GN7102903
92.10% 90.20% June 17, 2020
18 Nucleospin RNA Virus 250preps/Cat. No. 740956.250 100% 100% 100% 100% June 17, 2020
19 GF-1 Viral Nucleic Acid Extraction Kit Vivantis Technologies 25preps/Cat. No. GF-RD-025
50preps/Cat. No. GF-RD-050
100preps/Cat. No. GF-RD-100
88.30% 83.30% 94.40% June 24, 2020
20 GenAmplify™ Viral RNA Purification Kit (GA-RNA100) (version 2) Manila HealthTek, Inc., Philippines 100 preps/ GA-RNA100 96.61% 96.61% June 8, 2020
21 abGenixTM Automated Nucleic Acid Purification System AITbiotech Pte LT 64 preps/Ref No. 800811_C (Version 3.1) 96.67% 98.33% September 30, 2020
22 Genolution NX-48S Viral NA Kit (VN143) Genolution Inc (Seoul, South Korea) 24 preps/ Cat No: BC#5796 (NX-48S Extraction kit) Cat No: BC#5821 (Nextractor Equipment) Lot No: CVN143-201023 98.25% 51.78% December 2-7, 2020
23 Maxwell® HT Viral TNA Kit Promega Corporation 384 preps Cat. No. AX2340 100% December 2-7, 2020
24 NucleoMag® Virus Macherey-Nagel GmbH & Co. 96 preps Cat. No. 744800.1 100% November 17, 2020
25 MagaBio plus virus DNA/RNA Extraction and Purification II Hangzhou Bioer Technology Co., Ltd, Bioflux Cat No. BSC8M1E 48 preps 100% 90% December 7-15, 2020
26 Zybio Nucleic Acid Extraction Kit (Magnetic Bead Method) Zybio Inc., China Product no. B200-16 32 preps 100% 100% March 8-12, 2021
27 MAGMAX VIRAL/PATHOGEN KIT Applied Biosystems Life technologies, Texas, USA Cat no. A42352 200 preps 100% 94.44% October 2020
28 WUXI NEST MAGNETIC BEAD-BASED NUCLEIC ACID (DNA/RNA) EXTRACTION KIT Wuxi NEST Biotechnology Co. Ltd, WUXI Catalog No. SC906, Lot number: 020221ABA4 (64 preps) 94.83% July 20 – 21, 2021
29 MAGABIO PLUS VIRUS DNA/RNA EXTRACTION AND PURIFICATION KIT II (32T) Hangzhou Bioer Technology Co., Ltd, Bioflux 94.83% July 27 – 29, 2021
30 “ZYBIO Nucleic Acid Extraction Kit (Magnetic Bead Method) “ Zybio Inc., China “Cat No. T200-96 Lot No. 5107039” 96.67% Augist 27 – Sept 1, 2021
31 GeneAll Ribospin™ vRD GeneAll Biotechnology Co., Ltd “Cat. No. SG 1701 Lot No. 30221H26034” 100% September 16-20, 2021
32 RADI PREP Swab and Stool DNA/RNA KIT KH Medical Co., Ltd C, do, Republic of Korea “Ref No. MP002 Lot No. 210301” 100% September 22 – 24, 2021
33 UNI-MEDICA Nucleic Acid Extraction Reagent, 64T Shenzhen Uni-medica Technology Co. Ltd “Item Code: R025-02 Lot. No.: 20210701” 100% September 30-OCtober 5,2021
34 “BIOBASE Nucleic Acid Extraction Kit (Virus DNA/RNA Extraction 64T – Magnetic Bead method) “ Biobase Group “Lot No.: 20210325 (64 preps) Cat. No.: KYD01” 100% October 14 – 18, 2021
35 Magbead Viral DNA/RNA Kit Jiangsu CoWin Biotech Co., Ltd “Lot No.: 13170/22121 Cat. No.: NL-CA002-2020-49505 “ 98.33% October 25- 26, 2021
36 RNA/ DNA Purification Kit (PRESERVATION) Da An Gene co.,Ltd. “Lot No. 2021012 Ref No. DA0940” 86.67% November 3-10, 2021
37 TANBead® Nucleic Acid Extraction Kit Taiwan Advanced Nanotech, Inc. “Lot No.: W310294A Cat. No.: W665A46” 98.33% November 12-17, 2021
38 RNA/DNA Purification Kit (Magnetic Bead) Da An Gene Co., Ltd. Of Sun Yat-sen University “Lot. No. 2021001 Cat. No. DA0633” 100% Dec 2-6, 2021
39 GenAmplify™ BeaDxMax™ Viral DNA/RNA Extraction Kit Manila HealthTek, Inc., Philippines “Catalog No. GA-BDMA432 Lot No. 2021-07-001; Proteinase K & Magnetic Cover Lot No. 2021- 07-137 “ 96.67% January 7-12, 2022
40 ANDiS Viral RNA Auto Extraction and Purification Kit 3D Biomedicine Science & Technology Co Lot No.: NE05210805 100% February 16-21, 2022
41 GenAmplifyTM BeaDxMini Viral DNA/RNA Purification Kit Manila HealthTek Inc. Lot No.: BDXMIN092021-01 98.33% March 7-11, 2022
42 Exiprep 96 Viral DNA/RNA Kit Bioneer Corporation Catalog number: KB-4614 100% April 25, 2022

Results of RITM evaluations do not, in any way or form, represent a Certificate of Product Registration or Certificate of Authorization issued by the Philippine Food and Drug Administration (FDA).

The Institute is making this information available for public good and does not serve to endorse companies, manufacturers, or product brands for commercial purposes.