SARS-COV-2 Other NAAT

Updated as of 15 September 2022

NoKit NameManufacturerCatalogue No.Lot NumberSARS-CoV-2 Gene Target/s/ Mutations DetectedSensitivitySpecificityDate PerformedRemarks
1Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) on the Sansure Portable Molecule Station (Iponatic)Sansure Biotech, Changsha, Hunan Province, PRCMachine model/Ref No. S-Q31A
Kit Catalog number: S3102E
Lot No. 2021109ORF1ab, N100% (95% CI, 94.04% to 100.00%)100% (95% CI, 87.66% to 100.00%)July 7 - Aug 5, 2021Closed-system SARS-CoV-2 detection platform
2EasyNat Diagnostic Kit for Novel-Corona Virus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)USTAR Biotechnologies, Hangzhou Ltd.U20223200901ORF1ab, N gene95% (86.08% to 98.96%)100% (88.06% to 100%)November 28 - December 11, 2020Cartridge-based RT-LAMP
3AQ-TOP ™ COVID-19 Rapid Detection Kit Plus (Cat. no. SS-9940)SEASUN Biomaterials Inc.Cat. no. SS-9940Lot no. CVPR210701 and CVPR210801ORF1ab, N gene89.47% (78.48% to 96.04%)100% (88.43% to 100.00%)Sep 3-13, 2021Plate-based RT-LAMP
4Runmei SARS-CoV-2 and Variants Nucleic Acid Detection Kit, Apha KitHunan Runmei Gene Technology Co., Ltd--Lot No. 21090701RdRP
HV69/70 DEL, N501Y
96.23% (87.02 to 99.54%)100% (88.06% to 100%)Sep 28 - Oct 7, 2021SARS-CoV-2 PCR kit with Alpha variant associated mutation targets
5Runmei SARS-CoV-2 and Variants Nucleic Acid Detection Kit, Beta/Gamma KitHunan Runmei Gene Technology Co., Ltd--Lot No. 21090701RdRP
K417N, K417T, N501Y, E484K
94.12% (83.76% to 98.77%)100% (88.06% to 100%)Sep 28 - Oct 7, 2021SARS-CoV-2 PCR kit with Beta/Gamma variant associated mutation targets
6Runmei SARS-CoV-2 and Variants Nucleic Acid Detection Kit, Delta KitHunan Runmei Gene Technology Co., Ltd--Lot No. 21090701RdRP
L452R, P681R, E484Q
96.23% (87.02 to 99.54%)100% (88.06% to 100%)Sep 28 - Oct 7, 2021SARS-CoV-2 PCR kit with Delta, Kappa, Epsilon, variant associated mutation targets
7Runmei SARS-CoV-2 and Variants Nucleic Acid Detection Kit, Lambda KitHunan Runmei Gene Technology Co., Ltd--Lot No. 21090701RdRP
T76I, L452Q
69.81% (55.66% to 81.66%)100% (88.06% to 100%)Sep 28 - Oct 7, 2021SARS-CoV-2 PCR kit with Lambda variant associated mutation targets
8Runmei SARS-CoV-2 and Variants Nucleic Acid Detection Kit, Theta KitHunan Runmei Gene Technology Co., Ltd--Lot No. 21090701RdRP
LGV141-143, E484K
100% (93.28% to 100%)100% (88.06% to 100%)Sep 28 - Oct 7, 2021SARS-CoV-2 PCR kit withTheta variant associated mutation targets
9Detection Kit for 6 mutations in S gene of SARS-CoV-2 (ARMS-PCR)BGI PathoGenesis Pharmaceutical Technology Co., Ltd.PGI030019Lot No. 48202104001R and BGI20210317000Orf1ab
N501Y, K417N, E484K, HV79-70 DEL, K417T, A570D
96.55% (88.09% to 99.58%)100% (88.43% to 100.00%)Oct 16-25, 2021SARS-CoV-2 PCR kit with Alpha, Beta, Gamma variants associated mutation targets
10iDetect™ SARS-CoV-2 Detection Kit
CosMax Pharma Co., Ltd.,Ref. No. CMP-CVP001Lot. No. TRCP-K-01.TRCP-K-02RdRP, N88.33% (77.43% to 95.18%)100.00% (88.43% to 100.00%)December 8-15, 2021Plate-based RT-LAMP
11Allplex™ SARS-CoV-2 Master AssaySeegene, Inc.Cat No.: RV101284XLot No.: RVA32ICO3E, RdRp/S and N gene
S variant targets (HV 69-70 deletion, N501Y, E484K, Y144 deletion, P681H)
100.00% (91.19% to 100.00%)100.00% (88.43% to 100.00%)December 21-28, 2021SARS-CoV-2 PCR kit with variant associated mutation targets
12AllplexTM SARS-CoV-2 Variants I Assay and AllplexTM SARS-CoV-2 Variants II AssaySeegene, Inc.Cat No. RV10286X (Variants I) and Cat No.: RV10305X (Variants II)Lot No.: RVA521C02 (Variants I) and Lot No.: RVB721H02Variants I: RdRP, Spike protein mutations - E484K, N501Y, HV69/70 deletion
Variants II: Spike protein mutations - L452R, W152C, K417T, K417N
100.00% (92.13% to 100.00%)100.00% (88.43% to 100.00%)January 27 - Feb 3, 2022SARS-CoV-2 PCR kit with variant associated mutation targets