COVID-19 Public Health Response (Point-of-care Tests) Order 2021

The COVID-19 Public Health Response (Point-of-care Tests) Order 2021 came into force on 22 April 2021 and was revoked on 28 April 2023. This order had prohibited a person from importing, manufacturing, supplying, selling, packing, or using a point-of-care test for SARS-CoV-2 or COVID-19 unless approved by the Director-General of Health.

From 28 April 2023, point-of-care tests (POCTs) can be manufactured, imported and provided for sale without the requirement for approval under the POCT Order.

On 11 May 2023, the Director-General of Health Dr Diana Sarfati revoked the previous notices associated with the now former point-of-care tests. This notice can be found here: Revocation of Director-General Notices (PDF, 36 KB), and on the Gazette New Zealand website.

The previous order had replaced the Notice Under Section 37 of the Medicines Act 1981 (Gazette 2020-go1737) and broadened the group of Point-Of-Care tests the restrictions applied to.

The evaluation and authorisation framework used under the POCT Order can be found here:

Point-of-care Test (POCT) Evaluation Framework (PDF, 221 KB)

If you have any queries about the previous approval process, please email: [email protected]

Rapid antigen tests approved under the previous POCT Order

Product name(s)	Sample type(s)	Product configuration	Video and PDF instructions for use	Gazette notices
AllTest COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV802H) Self Test, JusChek COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV802H) Self Test, and Beright COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV-802H) Self Test	Oral Fluid (saliva)	Professional or self-test of any package size	AllTest COVID-19 Antigen Rapid Test (Oral fluid) (PDF, 231 KB) AllTest COVID-19 Antigen Rapid Test (Oral fluid) Instructions	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (PDF, 22 KB)
Rapid SARS-CoV-2 Antigen Test Card MP Biomedicals Asia Pacific Pte Ltd. (Singapore)	Nasal, nasopharyngeal and oropharyngeal swab	Professional use of any package size	Rapid SARS-CoV-2 Antigen Test Card instructions (MPbio) Procedure instructions (self-test) (PDF, 5.9 MB) Procedure instructions (professional use) (PDF, 2.2 MB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (PDF, 23 KB)
Roche SARS-CoV-2 Rapid Antigen Test (SD Biosensor) SD Biosensor (Republic of Korea)	Nasal, nasopharyngeal swab	Professional or self-test of any package size	Test yourself for COVID-19 with our rapid antigen self-test (Roche) SARS-CoV-2 Antigen Self Test Nasal (Roche) Quick Reference Guide	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
PanBio COVID-19 Ag Rapid Abbott Rapid Diagnostics Jena GmbH (Germany)	Nasal, nasopharyngeal swab	Professional or self-test of any package size	Procedure Video demonstration Panbio COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) IFU (PDF, 5.7 MB) Panbio COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) Quick Reference Guide (PDF, 4.3 MB) Panbio COVID-19 Ag Rapid Test Device (NASAL) (PDF, 953 KB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
CareStart COVID-19 Antigen CareStart COVID-19 home test Access Bio Inc (United States of America)	Nasal, nasopharyngeal swab	Professional or self-test of any package size	CareStart™ - COVID-19 Antigen RDT - Instructional Video (Accessbio) Access Bio Carestart Antigen Home Test Kit - Instructional Video (Access Bio Inc) Instructions for use - Carestart antigen (PDF, 5.3 MB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
Atomo COVID-19 Antigen Test Access Bio Inc (United States of America)	Nasal, nasopharyngeal swab	Professional or self-test of any package size	ARCV OA 010 Rev 1 Atomo COVID 19 Antigen AN Instructional Video (Aussie Pharma Direct): Instructions for use - Atomo COVID-19 Antigen Test (PDF, 2.6 MB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
CLINITEST Rapid COVID-19 Antigen Test Healgen Scientific Limited Liability Company (United States of America) or Zhejiang Orient Gene Biotech Co., Ltd (China)	Nasal, nasopharyngeal swab	Professional or self-test of any package size	How to use the CLINITEST® Rapid COVID-19 Antigen Self-Test (vials with buffer solution) (Siemens Healthineers) Instructions for use - CLINITEST Rapid COVID19 Antigen Test (PDF, 617 KB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
Healgen Rapid COVID-19 Antigen Test and Orient Gene Rapid COVID-19 Antigen Test Professional Self Healgen Scientific Limited Liability Company (United States of America) or Zhejiang Orient Gene Biotech Co., Ltd (China)	Nasal, nasopharyngeal swab	Professional or self-test of any package size	Healgen Rapid COVID-19 Antigen Test and Orient Gene Rapid COVID-19 Antigen Test Instructions for use - Orient Gene Rapid COVID19 Test (PDF, 8.1 MB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
BD Veritor System for Rapid Detection of SARS-CoV-2 and BD kit for rapid detection of SARS-CoV-2 (visually read) Becton, Dickinson and Company (United States of America)	Nasal swab	Professional or self-test of any package size	Rapid self-test (BD) BD Veritor Plus System for Rapid Detection of SARS CoV 2 (BD):(using the BD Veritor Plus Analyzer) Instructions for use - BD Veritor System for Rapid Detection of SARS-CoV-2 (professional use) (PDF, 1.1 MB) Instructions for use BD Veritor System for Rapid Detection of SARS (self test) (PDF, 4.2 MB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
Sofia SARS Antigen FIA Test kit with Sofia and Sofia 2 analyser Quidel Corporation (United States of America) or Puritan Medical Products Company LLC (United States of America)	Nasal swab	Professional or self-test of any package size	Including analyzer machine Instructions for use - Sofia SARS Antigen FIA Test kit with Sofia and Sofia2 analyser (PDF, 2.0 MB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
Ecotest COVID-19 Antigen Nasal Test Kit Assure Tech (Hangzhou) Co Ltd (China)	Nasal swab or nasal pen	Professional or self-test of any package size Please note the Ecotest SARS-CoV2 test is not recommended for use in children under the age of 2 years	Ecotest COVID19 Antigen (SELF TEST NASAL SWAB): How to Use video Instructions for use - Ecotest COVID19 Antigen Nasal Test kit (PDF, 228 KB) Instructions for use – Ecotest SARS-CoV-2 Antigen Rapid Tests (PDF, 497 KB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
STANDARD Q COVID-19 Ag Test STANDARD i-Q COVID-19 Ag Home Test SD Biosensor (Republic of Korea)	Nasal, nasopharyngeal swab	Professional or self-test of any package size	Guide for STANDARD Q COVID-19 Ag Test Nasal (professional use only) (SD Biosensor Official) Guide for STANDARD Q COVID-19 Ag Home Test (SD Biosensor Official) Guide for STANDARD Q COVID-19 Ag Home Test (1, 2, 5, 25T) (SD Biosensor Official) Instructions for use - Standard Q COVID19 Ag Test and Standard i-Q COVID19 Ag Home Test (PDF, 960 KB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
GenBody COVID-19 Ag Test GenBody Inc. (Republic of Korea)	Nasal, nasopharyngeal swab	Professional or self-test of any package size	GenBody Covid-19 Antigen Test (POC) Instructional Video (GenBody America) Instructions for use - GenBody COVID19 Antigen Test (PDF, 850 KB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 24 February 2022 (PDF, 34 KB)
BIOCREDIT COVID-19 Ag Home Test RapiGEN Inc. (Republic of Korea)	Nasal	Professional or self-test of any package size	BIOCREDIT COVID-19 Ag_RapiGEN Inc video demonstration BIOCREDIT COVID-19 Ag Home Test Nasal IFU (PDF, 1.8 MB) BIOCREDIT COVID-19 User Guide (PDF, 13 MB)	Expansion to Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 15 March 2022 (PDF, 22 KB)
FlowFlex SARS-CoV-2 Antigen Rapid Test Nasal Self-testing ACON Biotech (Hangzhou) Co., Ltd. (China)	Nasal	Professional or self-test of any package size	Operating instructions for Flowflex SARS-CoV-2 Antigen Rapid Test (Self-testing) – video	Expansion to Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 31 March 2022 (PDF, 22 KB)
Zybio SARS-CoV-2 Antigen Assay Kit Zybio Inc. (China)	Nasal swab	Self-test of any package size	Zybio SARS-CoV-2 Antigen Assay Kit instructions for use	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 22 April 2022 (PDF, 22 KB)
StrongStep SARS-CoV-2 Antigen Rapid Test Nanjing Liming Bio-Products Co., Ltd (China)	Nasal swab	Professional or self-test of any package size	StrongStep SARS-CoV-2 Antigen Rapid Test instructions for use (PDF, 22 MB) StrongStep SARS-CoV-2 Antigen Rapid Test (self-test) for nose swab –video StrongStep SARS-CoV-2 Antigen Rapid Test (professional use) – video	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 23 KB) Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 30 KB)
CLUNGENE COVID-19 Antigen Rapid Test Hangzhou Clongene Biotech Co., Ltd (China)	Nasal swab	Self-test of any package size	CLUNGENE COVID-19 Antigen Rapid Test instructions for use (PDF, 1.1 MB) Clungene COVID 19 Antigen Rapid Test Testing Procedure - video	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 23 KB) Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 30 KB)
INDICAID COVID-19 Rapid Antigen Test PHASE Scientific International, Ltd. (Hong Kong and United States of America)	Nasal swab	Professional or self-test of any package size	INDICAID COVID-19 Rapid Antigen Test instructions for use (PDF, 510 KB) INDICAID COVID-19 Rapid Antigen Test - How to Use (personal use) - video INDICAID COVID-19 Rapid Antigen Test - How to Use (professional use) - video	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 23 KB) Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 28 April 2022 (PDF, 30 KB)
SARS-CoV-2 Antigen Kit (Colloidal Gold) Goldsite Diagnostics, Inc. (China)	Nasal swab	Self-test of any package size	SARS-CoV-2 Antigen Kit (Colloidal Gold) for self-testing (PDF, 1.8 MB) How to test yourself for COVID-19 at home with a Rapid Antigen Test Kit(RAT) - YouTube	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 20 – 26 May 2022 (PDF, 22 KB)
OnSite COVID-19 Ag Rapid Test CTC Biotech Inc, (United States of America)	Nasal swab	Self-test	COVID-19 Ag Self Test – CE, WHO EUL (PDF, 2.7 MB) How to Use (Self-Testing/Personal Use) - YouTube	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 22 August 2022 (PDF, 22 KB)
AllTest SARS-CoV-2 Antigen Rapid Test Hangzhou Alltest Biotech Co Ltd, (China)	Nasal swab	Professional or self-test of any package size	How to Use AllTest SARS-CoV-2 Antigen Rapid test (self test) (Word, 1.2 MB) How to Use AllTest (Nasal) Professional Use (Word, 1008 KB) How to Use AllTest SARS-CoV-2 Antigen Rapid Test (Self-Testing) - YouTube	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 23 KB) Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 29 KB)
JusChek SARS-CoV-2 Antigen Rapid Test Hangzhou AllTest Biotech Co., Ltd. (China)	Nasal swab	Professional or self-test of any package size	How to Use JusChek SARS-CoV-2 Antigen Rapid Test (Word, 1.1 MB) How to use JusChek SARS-CoV-2 Antigen Rapid Test Professional Use (PDF, 232 KB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 23 KB) Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 29 KB)
BeRight SARS-CoV-2 Antigen Rapid Test Hangzhou AllTest Biotech Co., Ltd. (China)	Nasal Swab	Professional or self-test of any package size	How to Use BeRight (Nasal) Self-Testing (Word, 1.1 MB) How to Use BeRight (Nasal) Professional (Word, 273 KB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 23 KB) Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 29 KB)
Gold Standard Diagnostics (GSD) SARS-CoV-2 Antigen Rapid Test Hangzhou AllTest Biotech Co., Ltd. (China)	Nasal swab	Self-test of any package size	How to Use GSD NovaGen Self Test (PDF, 338 KB) How to Use GSD SARS-CoV-2 Antigen Rapid Test - YouTube	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 23 KB) Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 8 September 2022 (PDF, 29 KB)
LumiraDx SARS-CoV-2 Ag Test LumiraDx UK Ltd (United Kingdom)	Nasal, nasopharyngeal swab	Professional use only of any package size	How to Collect a Nasopharyngeal Swab Video How to Collect a Nasal Swab Video LumiraDx SARS-CoV-2 Ag Test - Instructions for use (PDF, 8.2 MB)	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 – 21 December 2022 (PDF, 22 KB)

LAMP tests approved under the previous POCT Order

Product name(s)	Lucira CHECK-IT COVID-19 Test Kit and Lucira COVID-19 All-in-One Test Kit
Manufacturer (country)	Lucira Health, Inc. (United States of America)
Sample type(s)	Nasal swab
Product configuration	Self-test of any package size
Approved 8 June 2022	Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (PDF, 22 KB)

Other Molecular Point-of-Care Tests approved for use (PDF, 32 KB)