FAQs

Q1: What is the difference between Self Testing and Professional Use?
A: Self Testing ART have been evaluated by MOH and HSA for its suitability for use by a layperson. The product inserts are tailored for the layperson, usability studies have been conducted to ensure that it is safe and easy to operate. The professional version can only be healthcare institutions, private hospitals, medical clinics or clinical laboratories. The Self Test version can be supplied to all users.

Q2: What is the shelf life and expiration date
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, we want to advise users to exercise extreme caution while doing so. Amongst the reasons are safety of the child and risk of inadequate specimen.

  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 an adult. When insufficient nasal specimen is collected, it can lead to an increased risk of false negative.

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

Q4: Is the FlowFlex more accurate that the other brands approved under the PSAR for self testing?
A: We think so. Have a look the FindDx independent evaluation reports here.
SD Biosensor Standard Q ART and Abbott Panbio ART have been listed on this list. In addition, University of Geneva has also published a paper to investigate the sensitivity of the FlowFlex against other brands when tested against Omicron and Delta variants. Read more.

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

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

Q7: How many tests are there in a box?
A: We have 1 test/box, 5 tests/box and 25 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 using the contact form stating your company name and desired quantity and we will send you a sales order.

Q9: May I self collect?
A: We are all in the middle of a pandemic. We cannot accept walk in customers.
Let’s stay safe and choose the free delivery option instead.

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

University of Geneva has conducted a study on the FlowFlex on the ability to detect Omicron and Delta. 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 submit your request here. 

We 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 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 phenomenon occurs 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 MSDS?
A: Download MSDS

Q17: The nasal swab appears yellow
A: There have been reports of swabs appearing yellow. This could be a result of the materials turning yellow naturally. Nevertheless, please contact us for a replacement of the swabs.

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

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

A: In late 2021, when FlowFlex became one of the first few brands that have achieved FDA EUA, traders in Europe illegally exported around 200,000 European approved tests to the USA. The European packaging differs from the USA version. In addition, doing so puts US consumers at risk of dated stocks and uncontrolled medical device supply chain. The FDA ordered a recall of this specific batch of 200,000 European tests from the US market to protect the US consumers. 

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 Europe version and is not affected by this recall.

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 is the design of the box used outside the USA. The recalled product was the European version and they are in dark blue. Fortunately, the HSA version shares a similar dark blue but not identical design. The HSA version includes the name of the PSAR holder Alcotech Pte. Ltd. For this reason, the safety communication issued by FDA does not affect FlowFlex ART in Singapore. 

You may view HSA's statement at the following links

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?

Packaging information

 

1 test/box (For self-testing)
Each Carton contains 300 tests and is packed in 300 boxes.
The box dimension is 120mm x 65mm x 27mm
The carton dimension is 565mm x 390mm x 365mm
The gross weight per carton is 9.6kg
The volume of each carton is 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)

5 tests/box (For self-testing)

Each Carton contains 600 tests and is packed in 120 boxes
The box dimension is 165mm x 80mm x 45mm
The carton dimension is 520mm x 395mm x 440mm
The gross weight per carton is 12.6kg
The volume of each carton is 0.09m³

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


25 tests/box (For self-testing)
Each Carton contains 600 tests and is packed in 24 boxes.
The box dimension is 210mm x 125mm x 93mm
The carton dimension is 445mm x 400mm x 410mm
The gross weight per carton is 9.2kg
The volume of each carton is 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)

25 tests/box (For professional use)
Each Carton contains 600 tests and is packed in 24 boxes.
The box dimension is 210mm x 125mm x 93mm
The carton dimension is 445mm x 400mm x 410mm
The gross weight per carton is 9.2kg
The volume of each carton is 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