https://www.tga.gov.au/sites/default/files/2022-08/2022-08-04_-_table-post-market_review_of_antigen_and_rapid_antigen_tests.

pdf

Key

ü Compliant with the WHO guidelines (LOD within range 100-1000 TCID50/mL) during TGA validation

û Non-compliant with the WHO guidelines (LOD does not fall within the range 100-1000 TCID50/mL) during TGA validation

† Where multiple RATs are included under the one (1) ARTG number and have the same product composition, they have
only been assessed once in the TGA testing. For example, if a product has a self-test and POCT version, only one was tested.

* In manufacturer provided evidence, variants that have only been tested with recombinant protein studies.

ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

374507 2San Pty Hangzhou Laihe LYHER Novel Coronavirus POCT Clinical: Delta and
Ltd Biotech Co Ltd (Covid-19) Antigen Test Kit Omicron, BA.4 and BA.5
(China) (Colloidal Gold)
Analytical: Delta and
Omicron, BA.4 and BA.5

374507 2San Pty Hangzhou Laihe LYHER Novel Coronavirus Self-test Clinical: Delta and
Ltd Biotech Co Ltd (Covid-19) Antigen Test Kit Omicron, BA.4 and BA.5
(China) (colloidal Gold) Self-Test

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Analytical: Delta and

Omicron, BA.4 and BA.5

345192 Abbott Abbott Rapid Panbio™ COVID-19 Ag Rapid POCT† Clinical: Delta, Omicron,
Rapid Diagnostics Jena Test Device (Nasopharyngeal) Alpha, Beta
Diagnosti GmbH
cs Pty Ltd (Germany) Analytical: Alpha, Beta,
Gamma, Delta, Kappa,
Zeta, Theta, Eta and
Omicron

345192 Abbott Abbott Rapid Panbio COVID-19 Antigen Self-test 41ADG637A ü ü ü ü Clinical: Omicron, Alpha,
Rapid Diagnostics Jena Self-test (Nasal) Beta and Delta
Diagnosti GmbH
cs Pty Ltd (Germany) Analytical: Alpha, Beta,
Gamma, Delta, Kappa,
Zeta, Theta, Eta and
Omicron

345192 Abbott Abbott Rapid Panbio COVID-19 Ag Rapid POCT† Clinical: Omicron, Alpha,
Rapid Diagnostics Jena Test Device (Nasal) Beta and Delta
Diagnosti GmbH
cs Pty Ltd Analytical: Alpha, Beta,
Gamma, Delta, Kappa,

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Zeta, Theta, Eta and

Omicron

385179 Alpha- Qingdao Hightop SARS-CoV-2 Antigen Rapid Self-test COV- ü ü ü ü Clinical: Delta, Omicron
Medics Biotech Co Ltd Test 1220169
Australia (China) Analytical: Alpha, Beta,
Pty Ltd Gamma, Delta, and
Omicron

385179 Alpha- Qingdao Hightop SARS-CoV-2 Antigen Rapid Self- Clinical: Delta, Omicron
Medics Biotech Co Ltd Test (without software) test†
Australia (China) Analytical: Alpha, Beta,
Pty Ltd Gamma, Delta, and
Omicron

386690 Alpha- Hangzhou Sejoy SARS-CoV-2 Antigen Saliva Self-test AU20220410 ü ü ü ü Clinical: Omicron
Medics Electronics & Lolly Test
Australia Instruments Co Analytical: Beta, Gamma,
Pty Ltd Ltd Delta, Omicron

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

386690 Alpha- Hangzhou Sejoy SARS-CoV-2 Antigen Saliva Self- Clinical: Omicron
Medics Electronics & Lolly Test (without software) test†
Australia Instruments Co Analytical: Beta, Gamma,
Pty Ltd Ltd Delta, Omicron

376310 AM Hangzhou Alltest All Test COVID-19 Antigen POCT† Clinical:

Diagnosti Biotech Co Ltd Rapid Test (Swab) (INCP-502)
cs (China) Analytical: Alpha*, Beta*,
Gamma*, Delta, and
Omicron

376310 AM Hangzhou Alltest All Test COVID-19 Antigen POCT† Clinical:

Diagnosti Biotech Co Ltd Rapid Test (Oral fluid) (ICOV-
cs (China) 802) Analytical: Alpha*, Beta*,
Gamma*, Delta, and
Omicron

376310 AM Hangzhou Alltest All Test SARS-CoV-2 Antigen Self-test ATNCP21110 ü ü ü ü Clinical:
Diagnosti Biotech Co Ltd Rapid Test (Nasal Swab) Self- 008
cs (China) Test (INCP-502H) Analytical: Alpha*, Beta*,
Gamma*, Delta, and
Omicron

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

ATCOV21110
376310 AM Hangzhou Alltest All Test COVID-19 Antigen Self-test 029 ü ü ü ü Clinical:
Diagnosti Biotech Co Ltd Rapid Test (Oral Fluid) Self-
cs (China) Test (ICOV-802H) Analytical: Alpha*, Beta*,
Gamma*, Delta, and
Omicron

376310 AM Hangzhou Alltest My Covid Test Antigen Rapid Self- Clinical:

Diagnosti Biotech Co Ltd Test (Oral Fluid) Self-Test test†
cs (ICOV-802H) Analytical: Alpha*, Beta*,
Gamma*, Delta, and
Omicron

333341 APAC Hangzhou Clungene COVID-19 Antigen POCT† Clinical: Delta, Omicron,
Security Clongene Biotech Rapid Test BA.2, BA.4 and BA.5
Pty Ltd Co Ltd (China)
Analytical: Alpha, Beta,
Gamma, Delta, Omicron,
BA.4 and BA.5

333341 APAC Hangzhou Clungene COVID-19 Antigen Self-test 2022020145 ü ü ü ü Clinical: Delta, Omicron,
Security Clongene Biotech Rapid Test (Self - testing) BA.2, BA.4 and BA.5
Pty Ltd Co Ltd (China)
Analytical: Alpha, Beta,

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Gamma, Delta, Omicron,

BA.4 and BA.5

346587 Atomo Access Bio Inc Atomo Covid-19 Antigen Test POCT Clinical: Delta, Omicron
Diagnosti (United States Of
cs America) Analytical: Alpha*, Beta*,
Limited Delta* Kappa*, Epsilon*,
Lambda* and Omicron

382031 AusDiagn Acon Biotech Flowflex SARS-CoV-2 Antigen Self-test COV2015250 ü ü ü ü Clinical: Delta, Omicron
ostics Pty (Hangzhou) Co Rapid Test (Self Testing)
Ltd Ltd (China) Analytical: Alpha*, Beta*,
Gamma*, Kappa*, Eta*,
Mu*, Epsilon*, Iota*,
Lambda*, Zeta* Theta*,
Delta and Omicron

W63420331
385653 Australia Guangzhou Wondfo 2019-nCoV Antigen Self-test ü ü ü ü Clinical: Delta, Omicron
Biotech Wondfo Biotech Test (Lateral Flow Method)
Pty Ltd Co Ltd (China) Analytical: Alpha, Beta,
Delta, Omicron, BA.4 and
BA.5

Page 6 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

375418 Australia Hangzhou Cellife Covid-19 Antigen Test POCT TL1L14 ü ü ü ü Clinical: Delta, Omicron
Health Testsea Cassette
Products Biotechnology Co Analytical: Alpha*, Beta*,
Central Ltd (China) Gamma*, Kappa*, Mu*,
Pty Ltd Lambda*, Iota*, Epsilon*,
Eta*, Theta*, Zeta*, Delta
and Omicron

375418 Australia Hangzhou Cellife Covid-19 Antigen Test Self- Clinical: Delta, Omicron
Health Testsea Cassette for Self test†
Products Biotechnology Co Analytical: Alpha*, Beta*,
Central Ltd (China) Gamma*, Kappa*, Mu*,
Pty Ltd Lambda*, Iota*, Epsilon*,
Eta*, Theta*, Zeta*, Delta
and Omicron

344030 Becton Becton Dickinson BD Veritor™ System for Rapid POCT 1155606 ü ü ü ü Clinical: Delta
Cancelle Dickinson and Company Detection of SARS-CoV-2
d by Pty Ltd (United States Of Analytical: Alpha, Beta,
sponsor America) Gamma, Kappa, Iota, and
Omicron.

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

334043 BGI BGI Europe A/S SARS-CoV-2 Virus Antigen Self-test Clinical: Delta and
Health (Denmark) Detection Kit (Colloidal Gold Omicron
(AU) Method)
Company Analytical: Delta
Pty Ltd

334043 BGI BGI Europe A/S SARS-CoV-2 Virus Antigen POCT Clinical: Delta and
Health (Denmark) Detection Kit (Colloidal Gold Omicron
(AU) Method)
Company Analytical: Delta
Pty Ltd

387550 BGI Innovita 2019 nCoV Ag Test (Latex Self-test Clinical: Delta, and
Health (Tangshan) Chromatography Assay) – Omicron
(AU) Biological Self- test
Company Technology Co Analytical: Delta, Beta
Pty Ltd Ltd (China) and Omicron

387550 BGI Innovita 2019 nCoV Ag Test (Latex POCT Clinical: Delta, Beta and
Health (Tangshan) Chromatography Assay) – Omicron
(AU) Biological POCT
Analytical: Delta, Beta
and Omicron

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Company Technology Co
Pty Ltd Ltd (China)

387020 Big Start Guangzhou 2019-nCoV Ag Rapid Test Kit Self-test Clinical: Delta, Omicron
Pty Ltd Decheng
Biotechnology Co Analytical: Alpha, Kappa,
Ltd (China) Delta, Omicron

345219 Biocelect SD Biosensor Inc STANDARD™ Q COVID-19 Ag POCT 58327KAAC1 ü ü ü ü Clinical: Delta, Omicron,
Pty Ltd (Korea - Republic Test
of) Analytical: Alpha*, Beta*,
Gamma*, Delta, Kappa*,
Epsilon*, Iota*, Lambda*,
Zeta*, Delta and Omicron,
BA.4 and BA.5

345219 Biocelect SD Biosensor Inc STANDARD™ Q COVID-19 Ag POCT† Clinical: Omicron

Pty Ltd (Korea - Republic Test Nasal swab
of) Analytical: Delta and
Omicron, BA.4 and BA.5

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

374065 Cole Guangzhou 2019-nCoV Ag Saliva Rapid POCT 05821068C ü ü ü ü Clinical: Delta, Omicron,
Workwea Decheng Test Card BA.1, BA.2, BA.4, BA.5
r PL Biotechnology Co
Ltd (China) Analytical: Beta*,
Gamma*, Epsilon*, Alpha,
Kappa, Delta and Omicron

374065 Cole Guangzhou V-Chek COVID-19 Antigen Self- Clinical: Delta, Omicron,
Workwea Decheng Saliva Test test† BA.1, BA.2, BA.4, BA.5
r PL Biotechnology Co
Ltd (China) Analytical: Beta*,
Gamma*, Epsilon*, Alpha,
Kappa, Delta and Omicron

374574 Complian Hangzhou Alltest SARS-CoV-2 Antigen Rapid POCT ATNCP21110 ü ü ü ü Clinical: Delta, Omicron
ce Biotech Co Ltd Test INCP-502-N 034
Managem Analytical: Alpha, Beta,
ent Gamma, Delta, Omicron
Solutions

374574 Complian Hangzhou Alltest COVID-19 Antigen Rapid Test POCT Clinical: Delta, Omicron,
ce Biotech Co Ltd (Oral Fluid) ICOV-802 BA.5
Managem

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

ent Analytical: Alpha, Beta,

Solutions Gamma, Delta, Omicron

374574 Complian Hangzhou JusChek COVID-19 Antigen Self-test Clinical: Delta, Omicron,
ce AllTest Biotech Rapid Test (Oral Fluid) ICOV- BA.5
Managem Co.,Ltd 802H
ent Analytical: Alpha, Beta,
Solutions Gamma, Delta, Omicron

374574 Complian Hangzhou JusChek SARS-CoV-2 Antigen Self- Clinical: Delta, Omicron
ce AllTest Biotech Rapid Test (Nasal Swab) test†
Managem Co.,Ltd INCP-502H Analytical: Alpha, Beta,
ent Gamma, Delta, Omicron
Solutions

374574 Complian Hangzhou Alltest JusChek SARS-CoV-2 Antigen POCT† Clinical: Delta, Omicron
ce Biotech Co Ltd Rapid Test INCP-502-N
Managem Analytical: Alpha, Beta,
ent Gamma, Delta, Omicron
Solutions

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

374574 Complian Hangzhou Alltest JusChek COVID-19 Antigen POCT Clinical: Delta, Omicron,
ce Biotech Co Ltd Rapid Test ICOV-802 (Oral BA.5
Managem Fluid)
ent Analytical: Alpha, Beta,
Solutions Gamma, Delta, Omicron

374574 Complian Hangzhou Beright SARS-CoV-2 Antigen POCT† Clinical: Delta, Omicron
ce AllTest Biotech Rapid Test INCP-502-N
Managem Co.,Ltd Analytical: Alpha, Beta,
ent Gamma, Delta, Omicron
Solutions

374574 Complian Hangzhou Beright COVID-19 Antigen POCT Clinical: Delta, Omicron,
ce AllTest Biotech Rapid Test ICOV-802 (Oral BA.5
Managem Co.,Ltd Fluid)
ent Analytical: Alpha, Beta,
Solutions Gamma, Delta, Omicron

384660 Dexcon Hangzhou Realy Novel coronavirus (SARS-Cov- Self-test 202203079 ü ü ü ü Clinical: Alpha, Beta,
Pty Ltd Tech Co Ltd 2) Antigen Rapid tests device Gamma, Delta, Epsilon and
(China) (nasal swab) Omicron

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Analytical: Alpha, Beta,

Gamma, Delta, Epsilon and
Omicron

382615 Doncaste Hangzhou Realy Novel Coronavirus (SARS- POCT Clinical: Delta and
r Tech Co Ltd Cov-2) Antigen Rapid Test Omicron
Australia (China) Cassette (swab)
Pty Ltd Analytical: Alpha, Beta,
Gamma, Delta, Epsilon and
Omicron

382615 Doncaste Hangzhou Realy Novel Coronavirus (SARS- Self-test Clinical: Delta and
r Tech Co Ltd Cov-2) Antigen Rapid Test Omicron
Australia (China) Cassette (swab)
Pty Ltd Analytical: Alpha, Beta,
Gamma, Delta, Epsilon

346643 Emergenc Assure Tech COVID-19 Antigen Rapid Test POCT Clinical:
e (Hangzhou) Co Device
Cancelle Technolo Ltd (China) Analytical: Delta*,
d by gy Pty Ltd Kappa*, Alpha*, Beta*,
sponsor Gamma*, Omicron

Page 13 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

372335 Emergenc Assure Tech Ecotest COVID-19 Antigen POCT† Clinical: Delta, Omicron
e (Hangzhou) Co Saliva Test Kit and BA.5
Technolo Ltd (China)
gy Pty Ltd Analytical: BA.4, BA.5,
Omicron, Delta, Alpha,
Beta, and Gamma

372335 Emergenc Assure Tech Ecotest COVID-19 Antigen Self-test I2110184 ü ü ü ü Clinical: Delta, Omicron
e (Hangzhou) Co Saliva Test kit (COV-S35Pen) and BA.5
Technolo Ltd (China)
gy Pty Ltd Analytical: BA.4, BA.5,
Omicron, Delta, Alpha,
Beta, and Gamma

372335 Emergenc Assure Tech Ecotest COVID-19 Antigen POCT Clinical: Delta, Omicron
e (Hangzhou) Co Nasal Test Kit and BA.5
Technolo Ltd (China)
gy Pty Ltd Analytical: BA.4, BA.5,
Omicron, Delta, Alpha,
Beta, and Gamma

Page 14 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

372335 Emergenc Assure Tech Ecotest COVID-19 Antigen Self-test Clinical: Delta, Omicron
e (Hangzhou) Co Nasal Test Self Test and BA.5
Technolo Ltd (China)
gy Pty Ltd Analytical: BA.4, BA.5,
Omicron, Delta, Alpha,
Beta, and Gamma

375754 Emergo Guangzhou 2019-nCoV Antigen Test POCT W19611112 ü ü ü ü Clinical: Delta, Omicron
Asia Wondfo Biotech (Lateral Flow Method)
Pacific Co Ltd (China) Analytical: Alpha*, Beta*,
Pty Ltd Gamma*, Kappa*, Delta
T/a and Omicron, BA.4 and
Emergo BA.5
Australia

374693 Eurofins Hangzhou Alltest SARS-CoV-2 Antigen Rapid POCT NCP2103002 ü ü ü ü Clinical: Delta, Omicron
Technolo Biotech Co Ltd Test (Swab) 5
gies (China) Analytical: Alpha*, Beta*,
Australia Gamma*, Delta and
Pty Ltd Omicron

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

374693 Eurofins Hangzhou Alltest GSD NovaGen SARS CoV-2 Ag Self- Clinical: Delta, Omicron
Technolo Biotech Co Ltd Rapid Test (Nasal swab) Self- test†
gies (China) testing Analytical: Alpha*, Beta*,
Australia Gamma*, Delta and
Pty Ltd Omicron

384538 Gardian Jiangsu Gardian T3 COVID-19-SARS- Self-test Clinical: Delta, Omicron,

Technolo Medomics CoV-2 Antigen Saliva BA.4
gies Pty Medical
Ltd Technology Co Analytical: Alpha*, Beta*,
Ltd (China) Gamma*, Kappa*,
Epsilon*, Eta*, Iota*,
Lambda*, Mu*, Delta,
Omicron, BA.4, BA.5,
BA.2.75

365551 Haemoki RapiGEN Inc BIOCREDIT COVID-19 Ag POCT Clinical: Delta, Omicron,
nesis Pty (Korea - Republic BA.5
Ltd of)
Analytical: Kappa*,
Epsilon*, Eta*, Lambda*,
Alpha, Beta, Gamma, Delta,
Omicron, Zeta,

Page 16 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

335597 Haemoki PCL Inc (Korea - PCL COVID19 Rapid FIA POCT Clinical:
nesis Pty Republic of)
Cancelle Ltd Analytical: Alpha*, Beta*,
d by Gamma*, Delta*, Omicron*
sponsor

370592 Health Arista Biotech ARISTA™ COVID-19 Antigen POCT Clinical: Delta, Omicron
Vision Pte Ltd Rapid Test
Australas (Singapore) Analytical: Alpha*, Beta*,
ia Pty Ltd Gamma*, Epsilon*,
Lambda*, Delta and
Omicron

345031 Hough BIOHIT SARS-CoV-2 Antigen Rapid POCT Clinical:

Pharma HealthCare Test Kit: Point of care testing
Pty Ltd (Hefei) Co Ltd Analytical: Alpha*, Beta*,
Gamma*, Delta*, Lambda*,
Omicron*

345031 Hough BIOHIT SARS-CoV-2 Antigen Lab Clinical:

Pharma HealthCare Quantitative Assay Kit
Pty Ltd (Hefei) Co Ltd (Enzyme-linked
(China) Immunoassay)

Page 17 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Analytical: Alpha*, Beta*,

Gamma*, Delta*, Lambda*,
Omicron*

345031 Hough BIOHIT SARS-CoV-2 Antigen Rapid POCT YPSA211002 ü ü ü ü Clinical:

Pharma HealthCare Test (Colloidal Gold Method)
Pty Ltd (Hefei) Co Ltd Analytical: Alpha*, Beta*,
(China) Gamma*, Delta*, Lambda*,
Omicron*

345031 Hough BIOHIT Hough Covid-19 Home Test Self-test SA211004 ü ü ü û Clinical:
Pharma HealthCare
Pty Ltd (Hefei) Co Ltd Analytical: Alpha*, Beta*,
SA220212 ü ü ü ü Gamma*, Delta*, Lambda*,
Omicron*

336146 Innovatio Innovation InnoScreen COVID-19 Antigen POCT SR20211000 ü ü ü ü Clinical: Delta, Omicron
n Scientific Pty Ltd Rapid Test Device 80
Scientific Analytical: Alpha*, Beta*,
Pty Ltd Gamma*, Delta, Kappa*,
Epsilon*, Iota*, Lambda*,
Zeta*, Delta and Omicron

Page 18 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

336146 Innovatio Innovation InnoScreen COVID-19 Antigen Self-test SR20211000 ü ü ü ü Clinical: Delta, Omicron
n Scientific Pty Ltd Rapid Test Device (Self Test) 79
Scientific (Australia) Analytical: Alpha*, Beta*,
Pty Ltd Gamma*, Delta, Kappa*,
Epsilon*, Iota*, Lambda*,
Zeta*, Delta and Omicron

385429 Jamach Hangzhou Jamach COVID-19 Antigen Self-test Clinical: Delta, Omicron,
Pty Ltd Testsea Test Cassette BA.4 and BA.5
Biotechnology Co
Ltd (China) Analytical: Alpha*, Beta*,
Gamma*, Kappa*, Mu*,
Lambda*, Epsilon*, Eta*,
Zeta*, Iota*, Theta*, Delta
and Omicron

343293 Life BioNote Inc NowCheck COVID-19 Antigen POCT Clinical:

Cancelle Bioscienc (Korea - Republic Test
d by e Pty Ltd of) Analytical: Gamma*,
Sponsor Alpha, Beta, Delta,
Omicron

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

385275 LRY Jiangsu Well Orawell COVID-19 Ag Rapid Self-test Clinical: Delta
Group of Biotech Co Ltd Saliva Test (SELF-TEST KIT)
Companie (China) Analytical: *Kappa,
s Pty Ltd *Epsilon, *Lambda, Alpha,
Beta, Gamma, Delta

332961 MD CTK Biotech Inc Aria and OnSite Covid-19 POCT F0415S2D00 ü ü ü ü Clinical: Delta, Omicron
Solutions (United States Of Rapid AG Test D
Australas America) Analytical: Alpha*, Beta*,
ia Pty Ltd Gamma*, Delta, Omicron

332961 MD CTK Biotech Inc OnSite COVID-19 Ag Self Test Self- Clinical: Delta, Omicron
Solutions test†
Australas Analytical: Alpha*, Beta*,
ia Pty Ltd Gamma*, Delta, Omicron

383823 MD Philosys Co Ltd Gmate COVID-19 Ag Saliva Self-test Clinical:

Solutions (Korea - Republic
Australas of) Analytical: Alpha, Beta,
ia Pty Ltd Delta

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

374063 Medi- Empowered CovClear COVID-19 Antigen POCT 02-299-2021 û û ü ü Clinical:

Stats ANZ Diagnostics LLC Test
Cancelle Pty Ltd (United States Of Analytical: Delta
d America)

333344 Medsuppl HANGZHOU COVID-19 Antigen Rapid Test POCT COVN211101 ü ü ü ü Clinical: Delta, Omicron
y BIOTEST Cassette 0-S
Australia BIOTECH NO Analytical: Alpha, Beta,
Pty Ltd LTD (China) Gamma, Delta, Omicron

333344 Medsuppl HANGZHOU RightSign COVID-19 Antigen Self- Clinical: Delta, Omicron
y BIOTEST Rapid Test Cassette test†
Australia BIOTECH CO LTD Analytical: Alpha, Beta,
Pty Ltd Gamma, Delta, Omicron

373711 MP MP Biomedicals Rapid SARS-CoV-2 Antigen POCT 8AL10-020 ü ü ü ü Clinical: Delta, Omicron
Biomedic Asia Pacific Test Card
als Analytical: Alpha*, Beta*,
Australas Gamma*, Epsilon*, Iota*,
ia Pty Ltd Kappa*, Theta*, Eta*,
Zeta*, Delta, Omicron,
BA.4 and BA.5

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

373711 MP MP Biomedicals Rapid SARS-COV-2 Antigen Self- Clinical: Delta, Omicron

Biomedic Asia Pacific Pte Test Card Self-test test†
als Ltd (Singapore) Analytical: Alpha*, Beta*,
Australas Gamma*, Epsilon*, Iota*,
ia Pty Ltd Kappa*, Theta*, Eta*,
Zeta*, Delta, Omicron,
BA.4 and BA.5

349933 Nature's GenBody Inc GenBody COVID-19 Ag POCT FMFA25211 ü ü ü ü Clinical: Delta, Omicron
Family (Korea - Republic
Australia of) Analytical: Alpha, Beta,
Pty Ltd Gamma, Delta, Epsilon,
Eta, Iota, Zeta, Omicron

383887 Nature's GenBody Inc Covid-19 Ag Home Test Self-test FXFGS27221 ü ü ü ü Clinical: Delta, Omicron
Family
Australia Analytical: Alpha, Beta,
Pty Ltd Gamma, Delta, Omicron

386305 Nuex Hangzhou COVID-19 Antigen Test Self-test Clinical: Delta, Omicron,
Medical Testsea Cassette - Self Test BA.4 and BA.5
Melbourn Biotechnology Co
e Ltd

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Analytical: Alpha*, Beta*,

Gamma*, Kappa*, Mu*,
Lambda*, Delta, Omicron

346588 Ortho- Ortho-Clinical VITROS Immunodiagnostic Lab Clinical:

Clinical Diagnostics Products SARS-CoV-2 Antigen
Diagnosti Reagent Pack, Calibrators, Analytical: Alpha*,
cs Controls, Extraction buffer Gamma*, Delta*, Kappa*
Australia
Pty Ltd

382250 Orvato Acon Biotech Flowflex SARS-CoV-2 Antigen Self-test COV2015130 ü ü ü ü Clinical: Delta, Omicron
Healthcar (Hangzhou) Co Rapid Test (Self-Testing)
e Pty Ltd Ltd (China) Analytical: Alpha*, Beta*,
(formerly Gamma*, Epsilon*, Mu*,
Medco Zeta*, Eta*, Theta*, Iota*,
Solutions Lambda*, Kappa*, Delta,
COV2015087 ü ü ü ü Omicron
)

Page 23 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

380739 Pale Blue Jiangsu SARS-CoV-2 antigen Test Kit POCT Clinical: Delta, Omicron,
Medical Medomics (LFIA) BA.4, BA.5
Trading medical
Pty Ltd technology Co Analytical: Alpha, Beta,
(formerly Ltd (China) Gamma, Delta, Kappa,
Jeninno Epsilon, Iota, Omicron,
Solutions BA.4, BA.5
Pty Ltd)

342512 Pantonic Access Bio Inc CareStart™ COVID-19 Antigen POCT CM21J05 ü ü ü ü Clinical: Omicron
Health test kit
Pty Ltd Analytical: Alpha*, Beta*,
Delta*, Kappa*, Epsilon*,
Lambda*, Omicron

342512 Pantonic Access Bio Inc CareStart COVID-19 Antigen Self-test CM21J01 ü ü ü ü Clinical: Omicron
Pty Ltd (United States Of Home Test
America) Analytical: Alpha*, Beta*,
Delta*, Kappa*, Epsilon*,
Lambda*, Omicron

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

373151 Pharma Hangzhou Testsea SARS-CoV-2 Antigen POCT Clinical: Delta, Omicron
Soul Pty Testsea Test Kit
Ltd Biotechnology Co Analytical: Delta and
Ltd (China) Omicron

373151 Pharma Hangzhou TESTSEALABS COVID-19 Self-test Clinical:

Soul Pty Testsea Antigen Test Cassette
Ltd Biotechnology Co Analytical: Delta and
Ltd (China) Omicron

374627 Pharma iXensor Co Ltd PixoTest® COVID-19 AG Test POCT Clinical: Delta and
Soul Pty (Taiwan) Kit Omicron
Ltd
Analytical: Alpha, Beta,
Gamma, Delta, Omicron

385550 Plus Hangzhou SecurePlus COVID-19 Antigen Self-test Clinical: Delta and
Medical Testsea Test Cassette Omicron, BA.4 and BA.5
Pty Ltd Biotechnology Co
Ltd (China) Analytical: Alpha, Beta,
Gamma, Delta, Omicron

Page 25 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

342390 Point Of Quidel Sofia® SARS Antigen FIA POCT 706953 ü ü ü ü Clinical: Omicron
Care Corporation
Diagnosti (United States Of Analytical: Alpha*, Beta*,
cs America) Gamma*, Delta* and
Australia Omicron
Pty Ltd

383819 ProcureN Hangzhou Medriva COVID-19 Rapid Self-test Clinical: Delta, Omicron
et APAC Testsea Antigen Test
Pty Ltd Biotechnology Co Analytical: Alpha*, Beta*,
Ltd (China) Gamma*, Omicron*,
Kappa*, Mu*, Epsilon*,
Eta*, Iota*, Theta*, Zeta*,
Delta

395414 Rapant Hangzhou Realy Novel Coronavirus (SARS- Self-test Clinical: Delta, Omicron
Pty Ltd Tech Co Ltd Cov-2) Antigen Rapid Test
(China) Device (nasal swab) Analytical: Delta,
Omicron

Page 26 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

352250 Roche SD Biosensor Inc SARS-CoV-2 Rapid Antigen POCT† Clinical: Delta, Omicron,
Diagnosti (Korea - Republic Test BA.4 and BA.5
cs of)
Australia Analytical: Alpha*, Beta*,
Pty Gamma*, Kappa*,
Limited Epsilon*, Iota*, Lambda*,
Zeta*, Delta, Omicron

352250 Roche SD Biosensor Inc SARS-CoV-2 Rapid Antigen POCT† Clinical: Delta, Omicron,
Diagnosti Test Nasal BA.4 and BA.5
cs
Australia Analytical: Alpha*, Beta*,
Pty Gamma*, Kappa*,
Limited Epsilon*, Iota*, Lambda*,
Zeta*, Delta, Omicron

352250 Roche SD Biosensor Inc SARS-CoV-2 Antigen Self Test Self-test QCO381052I ü ü ü ü Clinical: Delta, Omicron,
Diagnosti Nasal BA.4 and BA.5
cs
Australia Analytical: Alpha*, Beta*,
Pty Gamma*, Kappa*,
Limited Epsilon*, Iota*, Lambda*,
Zeta*, Delta, Omicron

Page 27 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

336661 Roche Roche Elecsys SARS-CoV-2 Antigen Lab N/A Analytical: Alpha*, Beta*,
Diagnosti Diagnostics assay Gamma*, Delta*, Kappa*,
Cancelle cs GmbH Zeta*, Theta*, Eta* and
d Australia (Germany) Epsilon*
Pty
Limited

387390 Safe Meril Diagnostics COVIFIND COVID-19 Antigen Self-test Clinical: Delta and
Interact Pvt Ltd (India) Self-Test Omicron
Pty Ltd
Analytical: Delta

334501 Solasta Hangzhou Realy Novel Coronavirus (SARS- POCT Clinical: Delta, Omicron
Life Pty Tech Co Ltd CoV-2) Antigen rapid test
Ltd Analytical: Alpha*, Beta*,
Gamma*, Epsilon*, Delta,
Omicron

334501 Solasta Hangzhou Realy Novel Coronavirus (SARS- Self-test Clinical: Delta, Omicron
Life Pty Tech Co Ltd Cov-2) Antigen Rapid Test
Ltd Device (nasal swab)

Page 28 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Analytical: Alpha*, Beta*,

Gamma*, Epsilon*, Delta,
Omicron

384537 Sonictec Hangzhou Realy Novel Coronavirus (SARS- Self-test Clinical: Delta, Omicron
Pty Ltd Tech Co Ltd Cov-2) Antigen Rapid Test
(China) Device Analytical: Alpha*, Beta*,
Gamma*, Epsilon*, Delta,
Omicron

395590 Sonictec Hangzhou Fanttest: Covid-19/Influenza Self-test Clinical: Delta, Omicron

Pty Ltd Fanttest Biotech A&B Antigen Test Kit COMBO
Co Ltd (China) Analytical: Gamma, Delta,
Omicron

Influenza: Influenza A
(H1N1, H3N2), Influenza B
(Victoria, Yamagata)

348890 Stonestar VivaChek Biotech VivaDiag™ SARS-CoV-2 Ag POCT Clinical: Delta, Omicron,
Wholesal (Hangzhou) Co Rapid Test BA.4 and BA.5
e Pty Ltd Ltd (China)
Analytical: Alpha*, Beta*,
Gamma*, and Epsilon*,

Page 29 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Delta, Omicron, BA.4 and

BA.5

348890 Stonestar VivaChek Biotech VivaDiag Pro SARS-CoV-2 Ag Self-test SE2106178 ü ü ü ü Clinical: Delta, Omicron,
Wholesal (Hangzhou) Co rapid test BA.4 and BA.5
e Pty Ltd Ltd (China)
Analytical: Alpha*, Beta*,
Gamma*, Epsilon*, Delta,
Omicron, BA.4 and BA.5

347092 SureScree BTNX Inc Surescreen Diagnostics POCT I2108208 ü ü ü ü Clinical: Omicron
n (Canada) COVID-19 Antigen Rapid Test
Australia Analytical: Alpha*, Beta*,
Pty Rapid Response™ COVID-19 Gamma*, Delta, Omicron
Limited Antigen Rapid Test Device

347092 SureScree BTNX Inc Rapid Response COVID-19 Self- Clinical: Omicron
n (Canada) Antigen Rapid Test Cassette - test†
Australia At Home Analytical: Alpha*, Beta*,
Pty Gamma*, Delta, Omicron
Limited

Page 30 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

387662 SureScree SureScreen SARS-CoV-2 Antigen Rapid Self-test Clinical:

n Diagnostics Ltd test Cassette (Nasal Swab)
Australia (United (Gold) Analytical: Delta,
Pty Kingdom) Omicron
Limited

387662 SureScree SureScreen SARS-CoV-2 Antigen Rapid POCT Clinical:

n Diagnostics Ltd test Cassette (Nasal Swab)
Australia (United (Gold) Analytical: Delta,
Pty Kingdom) Omicron
Limited

387662 SureScree SureScreen SARS-CoV-2 Antigen Rapid Self-test Clinical:

n Diagnostics Ltd test Cassette (Nasal Swab)
Australia (United (Gold) with RhinoSwab Junior Analytical: Delta,
Pty Kingdom) Omicron
Limited

345191 Suretest Beijing Wantai Wantai SARS-CoV-2 Ag Rapid POCT JNA2021108 ü ü ü ü Clinical: Delta, Omicron
Biologicalpharm Test (Colloidal Gold) 01
acy Enterprise Analytical: *Delta and
Co Ltd *Omicron

Page 31 of 33
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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

385370 Talbot Maccura Severe Acute Respiratory Self-test Clinical: Delta, Omicron
Medical Biotechnology Co Syndrome Coronavirus 2
Pty Ltd Ltd (China) (SARS-CoV-2) Antigen Assay Analytical: Delta,
Kit Omicron

391125 Talbot Guangzhou WhistlingTest 2019-nCoV Self-test Clinical:

Medical Decheng Saliva Ag EASY TEST
Pty Ltd Biotechnology Co Analytical: Delta, Alpha,
Ltd (China) Kappa

395591 Touch Vitrosens TouchBio SARS-CoV-2 & FLU Self-test Clinical: Alpha, Beta,
Biotechn Biyoteknoloji A/B Antigen Combo Test COMBO Delta, Eta, Omicron
ology Pty LTD STI (nasal)
Ltd (Turkey) Analytical: Delta,
Omicron

Influenza: Influenza A
(H1N1, H3N2), Influenza B
(Victoria, Yamagata)

388031 VITRYL Labnovation SARS-CoV-2 Antigen Rapid Self-test Clinical: Delta, Omicron,
AUS PTY Technologies Inc Test Kit BA.4 and BA.5
LTD (China) (Immunochromatography)

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ARTG Sponsor Manufacturer Test Kit name Type TGA validation of analytical sensitivity (Inactivated Manufacturer
of test virus) provided evidence

Batch Compliance, of variants Device

number tested, to WHO LoD quality
guidelines

Wild Delta Omicron

Type

Analytical: Delta
Omicron, BA.4 and BA.5

377136 Well Jiangsu Well Orawell COVID-19 Ag Rapid Self-test Clinical: Delta, Omicron
Biotech Biotech Co Ltd Saliva Test Device (Self test)
Pty Ltd (China) Analytical: Alpha, Beta,
Gamma, Delta, and
Omicron

Page 33 of 33