FAQs

Q1: What is the difference between Self Testing and Professional Use?
A: Self-testing ARTs have been evaluated by MOH and HSA for their suitability for use by a layperson. The product inserts are tailored for the layperson, and usability studies have been conducted to ensure that it is safe, easy to operate and convenient. This version can be supplied to all users.

The professional version, however, can only be used in healthcare institutions, private hospitals, medical clinics or clinical laboratories.

Q2: What is the shelf life and expiration date of my ART kit(s)?
A: 24 months from manufacture date. For more information click here.

Q3: Can the FlowFlex ART be used for children <2 years of age?
A: Yes. MOH has listed FlowFlex as one of the brands permitted for testing children under 2 years old.

However, we advise users to exercise extreme caution while doing so. Please be aware that:

1. Parents/caregivers performing the tests for the child can severely injure the child if the swab impales the nasal cavity. 
2. Children under 2 years of age tend to have less nasal specimen compared to adults. When insufficient nasal specimen is collected, there is an increased risk of false negatives.

Link to MOH website: https://ask.gov.sg/questions/506 or download PDF.

Q4: Is the FlowFlex more accurate than the other brands approved under the PSAR for self-testing?
A: We think so. Have a look at the FindDx independent evaluation reports here.
SD Biosensor Standard Q ART and Abbott Panbio ART have been listed.

In addition, the University of Geneva has published a paper evaluating the sensitivity of several ART brands against Omicron and Delta variants — Flowflex proved to have the highest sensitivity against both variants. Read more.

Q5: Which ARTs have been granted PSAR for sale to consumers?
A: Here is the list on the HSA website. Click here.

Q6: May I have more information on the manufacturer?
A: The FlowFlex ART is jointly developed by Acon Labs Inc. in California, USA, and Acon Biotech in China. FlowFlex ARTs are manufactured in Hangzhou, China. Click here to visit the Acon Labs Inc. website.

Q7: How many tests are there in a box?
A: We have 1 test/box, 3 tests/box, and 5 tests/box.

Q8: We are a company and have not got a credit card. May we use other payment methods?
A: Yes, please send us an email through the contact form stating your company name and desired quantity and we will send you a sales order.

Q9: May I self-collect?
A: Yes. Once payment has been made, you may collect your order from our office.

Q10: May I see proof that it can detect the Omicron variant?
A: Yes. Please have a look at this link: https://www.flowflex.sg/blogs/news/omicron-variant-update-29th-nov-2021

The University of Geneva has conducted a study on the FlowFlex ARTs' ability to detect the Omicron and Delta variants. Read the report here

Q11: Are the buffers prefilled? Or does the user have to pour the buffer into the buffer tube?
A: The buffers are sealed individually and prefilled. No transferring of buffer is needed.

Q12: I bought the FlowFlex from the supermarket or pharmacy but it is missing a swab or buffer.
A: Please fill in our defects reporting form here. 

We will typically resolve it within 1-2 working days. 

Q13: Should I refer to the expiry date stated on the buffer or the box?  
A: Please refer to the expiry date stated on the box. 

Q14: Do you provide a tube stand to hold the buffer?  
A: The box is specially designed to hold the buffer tube. Gently pop the hole indicated on the box and you can insert the tube as shown in the image below.

Q15: Why do the control line (C) and test line (T) fade when I read my result? 
A: This is most likely because the results were interpreted after 30 minutes. Please interpret the results between 15-30 minutes as stated in the product insert. 

Q16: May I have the Material Safety Data Sheet?
A: Download MSDS

Q17: The nasal swab appears yellow, what should I do?
A: There have been reports of swabs appearing yellow; this could be the result of a natural colour change. Please be assured that the swabs are still safe for usage. Nevertheless, if you would like a replacement, please contact us and we will send it to you. 

Q18: May we export the FlowFlex ARTs?
A: Every country regulates medical devices differently. When you export the FlowFlex ARTs, it may breach the regulations in the receiving country. This can lead to the recall of unauthorized versions of FlowFlex ARTs in those countries. 

Q19: Was the FlowFlex recalled in the USA? Why was there a safety communication issued by the FDA on 1st March 2022?

A: In late 2021, when FlowFlex was one of the first few brands that received an Emergency Use Authorisation from the FDA, traders in Europe illegally exported around 200,000 European-approved tests to the USA with packaging that was not approved in the US. Doing so put US consumers at risk of dated stocks and an uncontrolled medical device supply chain. Hence, the FDA ordered a recall of this specific batch of 200,000 European tests from the US market to protect US consumers. 

The FDA safety communication is meant for the US audience only. It serves to remind US consumers to avoid using the 'dark blue box', which was not US-approved packaging. 

The HSA version — the version we sell — shares a similar dark blue design but includes the name of the PSAR holder, Alcotech Pte. Ltd, indicating that it is approved for sale in Singapore. 

For this reason, the safety communication issued by the FDA does not affect FlowFlex ART in Singapore. 

In summary, this recall pertains to rectifying the illegal imports from Europe to the USA. Product quality has not been the reason for this recall. The Singapore HSA-approved version differs from both the US and European versions and is not affected by this recall.

You may view HSA's statement at the following links:

• The Straits Times
• CNA
• TODAY
• HSA  
  
  

Q20: May I have the FDA EUA, CE Mark for self-testing, HSA Pre-Market Approval (PMA), HSA Pandemic Special Authorisation Route (PSAR), TGA, WHO EUL approval?

• FDA EUA
• CE Mark for Self Testing
• HSA Pre-Market Approval (PMA)
• HSA Pandemic Special Authorisation Route (PSAR)
• TGA Approval 
• WHO EUL
  
  

Packaging information

 

1 test/box (For self-testing)
Each carton contains 300 tests packed in 300 boxes.
Box dimensions: 120mm x 65mm x 27mm
Carton dimensions: 565mm x 390mm x 365mm
Gross weight per carton: 9.6kg
Volume of each carton: 0.08m³

Individually wrapped contents
1 x COVID-19 Test Kit Cassette
1 x Individually Filled Extraction Buffer/Prefilled Buffer
1 x Nasal Swab
1 x Waste Bag
Product Insert (Download)

Each carton contains 600 tests packed in 120 boxes
Box dimension: 165mm x 80mm x 45mm
Carton dimension: 520mm x 395mm x 440mm
Gross weight per carton: 12.6kg
Volume of each carton: 0.09m³

Individually wrapped contents
5 x COVID-19 Test Kit Cassette
5 x Individually Filled Extraction Buffer/Prefilled Buffer
5 x Nasal Swab
5 x Waste Bag
Product Insert (Download)

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25 tests/box (For self-testing)
Each carton contains 600 tests packed in 24 boxes.
Box dimension: 210mm x 125mm x 93mm
Carton dimension: 445mm x 400mm x 410mm
Gross weight per carton: 9.2kg
Volume of each carton: 0.073m³

Individually wrapped contents
25 x COVID-19 Test Kit Cassette
25 x Individually Filled Extraction Buffer/Prefilled Buffer
25 x Nasal Swab
25 x Waste Bag
Product Insert (Download)

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25 tests/box (For professional use)
Each Carton contains 600 tests packed in 24 boxes.
Box dimension: 210mm x 125mm x 93mm
Carton dimension: 445mm x 400mm x 410mm
Gross weight per carton: 9.2kg
Volume of each carton: 0.073m³

Individually wrapped contents
25 x COVID-19 Test Kit Cassette
25 x Individually Filled Extraction Buffer/Prefilled Buffer
25 x Nasal Swab
25 x Waste Bag
Product Insert 

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