FAQs

Who are we authorized to sell to?

For purposes of COVID 19 Surveillance and Deterrence, we sell to any facility or organization suffering from the pandemic:

  • Government entities and agencies
  • Schools and Universities
  • Private Enterprises like Casinos, Cruise Lines, Hotels, Retail, Entertainment companies, Sports Teams, Film Companies, Media Companies etc.
  • Small, Medium, or Large Scale Factories and Plants
  • Transportation Industry and Airports
  • Any Small, Medium, or Large Sized Employers
  • Nursing Homes
  • City municipalities and Emergency Medical Services
  • Critical state work environments such as first responders, energy, power, engineering, IT, public health, water, transportation, telecommunications
  • Hospital groups and individual hospitals
  • Urgent care groups and individual urgent care facilities
  • Convalescent hospitals
  • Assisted living/rehab facilities
  • Health care providers/large medical groups

Is there a minimum order requirement?

  • There is no minimum order and we have a robust supply chain.

What is the lead time for an order?

  • 21 days, typically, but we will let you know before each order and strive to fill ASAP

Is your disposable test kit CLIA certified?

Under the current schema (please check with your local Health Boards and Relevant Agencies for accurate advisory):

a.      In California, the regulation for COVID19 DTK testing is covered by National CLIA guidelines. Four states do not go through CLIA but through their respective state’s Department of Health (NY, FL, MA, and NV).

b.      Therefore, our product should first be validated by a high complexity CLIA lab in your vicinity. The current standard if we use the RT-PCR FDA guidance as a reference example is to test 30+ and 30 – RT-PCR COVID19 blood samples. Additional control studies of class specificity and cross reactivity are required as well, please consult your local agency requirements for updated protocols.

c.      If validation is consistent with testing requirements for sensitivity and specificity demanded by the local guidelines then that laboratory is authorized to perform COVID19 serology testing using the DTK they have validated.

d.      The high complex laboratory is then also able to validate moderate and low complexity environments in their community such as POC under their CLIA umbrella using +/- sample testing under their review.

e.       Once a Covid19 DTK receives a POC designation for COVID19 diagnosis by the FDA then the above CLIA schema would not have to be followed for that DTK. At this point, no DTK has received that approval by the FDA.

Are samples available?

  • If paid for, yes, but even samples must go within the US to High Complexity CLIA laboratories

What is the unit cost of the Test Kit?

  • Pricing is contingent on the order quantity
  • Production capacity is currently 50 Million units per month
  • Shipping and fees associated are paid by the purchaser
  • We have pass-through 3rd party logistic partners we can introduce you to

What is the return policy?

  • No returns unless it is defective

Who is the contact person(s) for order processing/sales and accounting?

Where could I get documentation, literature on FDA status, approval, allowance and Chinese FDA or CE?

How many Rapid DTK (Disposable Test Kit) per box and how many Microfluidic Reagent Chips per box?

  • 10 individual pouch/bag test kits per box with 1 single bottle of diluent
  • 10 individual Microfluidic Reagent Chips per box

What is the shelf life of each Test Kit?

  • 6 months
  • Store DTKs at 10-30C, do not expose to light
  • Store Microfluidic Reagent chips in refrigerator

How do you interpret results on a Test Kit?

  • See Brochure for DTKs
  • For Microfluidic Reagent Chips and the M2 and M5 analyzer: Ag Chip Blood >3 Live Virus Positive, for Saliva or Oral Swab > 1 Live Virus Positive; Antibody Chips (IgM, IgG, and Total Antibody) >1 Positive

Do I need an M2 or M5 machine to use the Test Kit?

  • No, you do not need the machine to read the results for DTKs
  • M2 and M5 machine read the Microfluidic Reagent Chips which are laboratories in a chip giving semi-quantitative read-outs on live virus incubating in the blood prior (N-antigenemia) to subject converting into being infectious, also Chip can read live virus in Saliva and Oral Swab samples. Other Chips read IgM, IgG, and Total Antibody levels to the S1 spike protein reflective of immunity status post-infectious or post-vaccination. The M2 and M5 currently are the only point of care system capable of reading N-antigenemia for SARS-CoV-2.

How long does it take to get the results of a Test Kit?

  • 15 minutes for positive or negative results given for COVID-19 IgM & IgG for the DTKs and MRCs
  • 13-15 minutes for semi-quantitative read-out of live virus in blood, saliva, or oral swab for the Ag Microfluidic Reagent Chip (Live Virus Chip) read in in the M2 and M5

How accurate are the whole blood test results from the Test Kits?

  • IgM 97.35% Sensitivity  IgM 97.81% Specificity
  • IgG 99.12% Sensitivity  IgG 98.54% Specificity

For Hospital inpatients

What is the WATMINDUSA COVID-19 suggested containment protocol?

Do the Rapid Test Kits contain the lancet and alcohol swab?

  • NO, because we do not want to encourage self-testing until it’s permitted by the FDA

Will both testing systems be available to sell?

  • We can sell the COVID19 Microfluidic Reagent Chips and the M2 or M5 machines
  • For pricing for M2, M5 machines and Microfluidic Reagent Chips please call us or email us at 310-710-2317 or sales@watmindUSA.com

Will both testing systems be available to sell?

  • All products and systems are available for purchase

What is the M2 Machine?

  • Single Sample Processing Unit/Semi to Quantitative Microfluidic Chemiluminescent Rapid Analyzer
  • The only portable 4th generation Microfluidic Chemiluminescent Analyzer available in the market that tracks COVID19
  • 10 lbs (hand carry-able)
  • Quantitative Ag (LIVE VIRUS), IgG & IgM and Total Antibody Results (Previous Exposure Time Frame to COVID-19, Incubating COVID19 in the Blood, Detects before Subject is Infectious and COVID-19 Immunity Status)
  • 13-15 Minute Blood Processing Time, Maintenance Free, Auto-calibration, QR coded parameter settings, connect to LIS/HIS, built in GPS
  • Digital data collection, 4G, WiFi, Bluetooth enabled
  • Solid and Beautiful Design
  • Full Warranties

What is the M5 Machine?

  • Four Chamber Processing Unit/Semi to Quantitative Microfluidic Chemiluminescent Rapid Analyzer
  • 4 subjects every 15 minutes through-put
  • The only portable 4th generation Microfluidic Chemiluminescent Analyzer available in the market that tracks COVID19
  • 22 lbs (portable with a handle)
  • Quantitative Ag (LIVE VIRUS), IgG & IgM and Total Antibody Results (Previous Exposure Time Frame to COVID-19, Incubating COVID19 in the Blood, Detects before Subject is Infectious and COVID-19 Immunity Status)
  • 13-15 Minute Blood Processing Time, Maintenance Free, Auto-calibration, QR coded parameter settings, connect to LIS/HIS, built in GPS
  • Digital data collection, 4G, WiFi, Bluetooth enabled
  • Solid and Beautiful Design
  • Full Warranties
FAQs