Approved rapid antigen tests (RATs) and other point-of-care tests for COVID-19

A list of approved rapid antigen tests (RATs) and loop-mediated isothermal amplification (LAMP) tests.

Page last updated: 22 December 2022

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Approved RATs and how to use them

All RAT devices should be kept out of reach of young children and stored safely according to the manufacturer’s instructions.

The Ministry of Health recommends always following the manufacturer’s instructions for using RAT devices, as not all brands are the same. You can watch a video explaining how to use some of these tests from the links in the table below.

More information on taking a RAT is available on Unite Against COVID-19.

The COVID-19 Public Health Response (Point-of-care Tests) Order 2021 came into force 22 April 2021. This order prohibits a person from importing, manufacturing, supplying, selling, packing, or using a point-of-care test for SARS-CoV-2 or COVID-19 unless the Director-General of Health has:

  • authorised the person’s activity or
  • exempted the point-of-care test from the prohibition.

Rapid antigen tests that are exempted and authorised for use in New Zealand are listed in the table below and published on the New Zealand Gazette.

Any person can import, manufacture, supply, sell, pack, or use the approved RATs listed below.

Applications to add a new RAT device to the approved Ministry of Health list can be made via the Legislation and Orders section

The Ministry of Health continues to evaluate new applications and any updates to the authorised list is published by gazette notice and included in the below table.

Product name(s) 

Manufacturer (country) 

Sample type(s) 

Product configuration 

Video and PDF instructions for use 

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 

PanBio COVID-19 Ag Rapid 

Abbott Rapid Diagnostics Jena GmbH (Germany) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

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 

Atomo COVID-19 Antigen Test 

Access Bio Inc (United States of America) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

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 

Healgen Rapid COVID-19 Antigen Test and Orient Gene 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 

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 

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 

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

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 

GenBody COVID-19 Ag Test 

GenBody Inc. (Republic of Korea) 

Nasal, nasopharyngeal swab 

Professional or self-test of any package size 

BIOCREDIT COVID-19 Ag Home Test RapiGEN Inc. (Republic of Korea) Nasal Professional or self-test of any package size

FlowFlex SARS-CoV-2 Antigen Rapid Test

ACON Biotech (Hangzhou) Co., Ltd. (China)

Nasal

Professional or self-test of any package size

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 

StrongStep SARS-CoV-2 Antigen Rapid Test

Nanjing Liming Bio-Products Co., Ltd (China) Nasal swab  Professional or self-test of any package size 

CLUNGENE COVID-19 Antigen Rapid Test

Hangzhou Clongene Biotech Co., Ltd (China) Nasal swab Self-test of any package size

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
SARS-CoV-2 Antigen Kit (Colloidal Gold) Goldsite Diagnostics, Inc. (China) Nasal swab Self-test of any package size
CTC Biotech Inc, (United States of America) Nasal swab Self-test

AllTest SARS-CoV-2 Antigen Rapid Test

 

Hangzhou Alltest Biotech Co Ltd, (China)

Nasal swab

Professional or self-test of any package size

JusChek SARS-CoV-2 Antigen Rapid Test

 

Hangzhou AllTest Biotech Co., Ltd. (China)

Nasal swab

Professional or self-test of any package size

BeRight SARS-CoV-2 Antigen Rapid Test

Hangzhou AllTest Biotech Co., Ltd. (China)

Nasal Swab

Professional or self-test of any package size

Gold Standard Diagnostics (GSD) SARS-CoV-2 Antigen Rapid Test

Hangzhou AllTest Biotech Co., Ltd. (China)

Nasal swab

Self-test of any package size

LumiraDx SARS-CoV-2 Ag Test LumiraDx UK Ltd (United Kingdom)  Nasal, nasopharyngeal swab  Professional use only of any package size

Approved LAMP tests

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

Other Molecular Point-of-Care Tests approved for use 

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