The WELLlife COVID-19 / Influenza A&B Home Test differentiates between SARS-COV-2, influenza A and influenza B antigens with a single test.

FDA Emergency Use Authorization (EUA) Approved for:

  • Point of Care (POC) – for use in CLIA Certified Patient Care Settings
  • Over the Counter (OTC) – for Home Use

covid home

 

quick step process

 

Features and Benefits

  • Ease of Use: Differentiate between SARS-COV-2, influenza A, and influenza B antigens with an easy nasal swab.
  • Rapid & Convenient: Results are available in just 10 minutes, with kits that can be stored in 36°F-86°F(2°C-30°C), allowing testing anytime and anywhere.
  • Reliable: The test demonstrates outstanding clinical performance, providing reliable results.
  • Extended Detection Window: Offers a broader detection window for differentiation of SARS-COV-2, influenza A, and influenza B antigens within five (5) days of symptom onset.

 

Point of Care (POC)

WELLife Combo Covid-19 Flu A&B Test 【Sales Sheet】MD WELLlife COVID-19 & Influenza A&B POC (pdf)

WELLife POC HCP Fact Sheet (POC Health Care Professional Fact Sheet) WELLife POC HCP Fact Sheet (POC Health Care Professional Fact Sheet) (pdf)

WELLife POC PATIENT Fact Sheet (POC Patient Fact Sheet) WELLife POC PATIENT Fact Sheet (POC Patient Fact Sheet) (pdf)

WELLife POC EUA240004 FDA LOA (POC FDA Letter of Authorization) WELLife POC EUA240004 FDA LOA (POC FDA Letter of Authorization)  (pdf)

WELLife POC Package Insert (POC Package Insert)  WELLife POC Package Insert (POC Package Insert)  (pdf)

WELLife POC Quick Reference Instructions (POC Quick Reference Instructions)   WELLife POC Quick Reference Instructions (POC Quick Reference Instructions)  (pdf)

Order Form

Over the Counter(OTC)

WELLife Combo Covid-19 Flu A&B Test 【Sales Sheet】MD WELLlife COVID-19 & Influenza A&B OTC (pdf)

WELLife OTC Package Insert WELLife OTC Package Insert (pdf)

WELLife OTC HCP Fact Sheet WELLife OTC HCP Fact Sheet (pdf)

WELLife OTC Quick Reference Instructions WELLife OTC Quick Reference Instructions (pdf)

WELLIfe OTC EUA240011 FDA LOA (OTC FDA Letter of Authorization)  WELLIfe OTC EUA240011 FDA LOA (OTC FDA Letter of Authorization) (pdf)

 

Accuracy SARS-COV-2 Influenza A Influenza A
Positive Percent Agreement (PPA) 87.5% 85.9% 86.8%
Negative Percent Agreement (PPA) 99.7% 99.7% 99.7%

Ordering information

Description Item Code Size Complexity Packaging Size
WELLLifeTM COVID-19/Influenza A&B Home Test WV01P0001 2T/Kit OTC Home Use 90 Kits/Carton
WELLLifeTM COVID-19/Influenza A&B Test WV01P0002 25T/Kit CLIA WAIVED 24 Kits/Carton
WELLLifeTM COVID-19/Influenza A&B Test Control Kit WV01P0003 5T/Kit CLIA WAIVED TBD

Pallet Size:
120x100x220mm by sea
120x100x155mm by air
The height above are the upper limit.

Covid Combo 2 Pack OTC:
90 kits/180T per carton
Carton Size: 465x330x205mm
For 1 Pallet by Sea: 72 cartons = 12,960T
By Air: 48 cartons = 8,640T

Covid Combo POC:
24 kits/600T per carton
Carton Size: 540x435x270mm
For 1 Pallet by Sea: 42 cartons = 25,200T
By Air: 30 cartons = 18,000T

Reimbursement Rate

Year HCPCS MOD EFF_Date Indicator Rate Short Desc Long Desc
2024 87428   20240101 N $70.29 Sarscov & inf vir a&b ag ia Detection test by immunoassay technique for severe acute respiratory syndrome
2024 87428 QW 20240101 N $70.29 Sarscov & inf vir a&b ag ia Detection test by immunoassay technique for severe acute respiratory syndrome