CLIA, or the Clinical Laboratory Improvement Amendments of 1988 are regulations that impose federal standards on all U.S. testing facilities or sites that use human specimens to diagnose, prevent, or treat disease. Under CLIA, there are different test complexity categories assigned to tests based on seven criteria scored by CLIA including criteria such as risk for an incorrect result and sample specimen type. The most simple tests with the lowest risk for incorrect results are given the status of CLIA waived, and are therefore FDA cleared for home use.
Additionally, to use a CLIA waived machine, a site must only have a CLIA certificate and follow the manufacturer’s instructions on how to operate the test. Other CLIA requirements that apply to non-CLIA waived tests, such as inspections, certifications, and meetings of standards do not apply to CLIA waived tests. Therefore, getting started with and operating CLIA waived tests is a fairly simple process. For more information regarding CLIA, please visit here, and for more information on how to obtain a CLIA waiver, please visit here.
# Abbot ID Now
# BD Veritor Plus System
# GeneXpert Xpress
# Quidel Sofia 2 Flourescent Immunoassay Analyzer
# Siemens Clinitek Status + Urine Analyzer
# Cobas Liat System
# OraSure Technologies
# CoronaCheck – rapid antigen test
# CardioCheck Plus
# Afinion 2
# Curo L5
# AimStrip Tandem
# COAG-Sense P2 Meter
# Cholestech LDX
# HIGI Machine
# INSTi – HIV
# AdexusDx Analyzer
Abbott ID NOW™ by Abbott Point of Care Diagnostics is a device manufactured by Abbott Point of Care Diagnostics for molecular point-of-care tests such as COVID-19, influenza A & B, group A streptococcus, and Respiratory Syncytial Virus (RSV).
This device is CLIA waived for all tests, can store up to 999 patient test results, and provide output from results such as patient ID, user ID, date and time of test, and result.
ID NOW uses a liquid solution designed to deactivate the virus and break it apart to expose the RNA. The instrument then amplifies the virus hundreds of millions of times to make it more easily detectable and determine at a molecular level whether the sample is positive or negative.
This Device is CLIA waived for all tests
Billing: CPT code(s) 87502QW for Influenza A&B and 87634QW for R
COVID-19, influenza A & B, group A streptococcus, and Respiratory Syncytial Virus (RSV).
Type of Machine
Molecular point-of-care (POC) test
Time to result
5-13 minutes total
Sensitivity ≥ 98.6%
Specificity ≥ 98.6%
Point of care antibody test
Simple sample prep, intuitive interface, step-by-step guidance for instrument use and workflow, and built-in quality control checks
How to get started
Submit an inquire form
For training on antibody testing, visit this link
For training on antigen testing, visit this link
This device is CLIA waived for all tests
Covid-19 antigen and antibody
microfluidic immunofluorescence assay
11 minutes from time test starts running
Prep + test time = 12 minutes total
Covid Ab: 100% positive and negative agreement
Covid Ag: 97.6% positive and 96.6% negative agreement
The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay test manufactured by LumiraDx UK Ltd that can be used to detect Covid-19 in patients who are in the first twelve days of symptom onset, or who may not be symptomatic at all.
The LumiraDx Platform can run a multitude of tests, however, only Covid-19 antigen and antibody tests are approved under EUA in the US to run on this machine.
This machine is CLIA waived for all tests
Use CPT code 87426 for antigen testing
The GeneXpert Xpress is a CLIA waived, point of care PCR testing machine manufactured by Cepheid to test for respiratory infectious diseases such as Covid-19, RSV, Flu, and strep A. This machine offers combined tests and has the capability to test for Covid-19, flu, and RSV or flu and RSV with one patient sample.
Additionally, this single machine can run up to four patient tests at one time. Running tests on this machine are simple as there are few steps and the software and technology is intuitive and easy to use.
* Once the test starts running, however prep time is not extensive
Covid-19, Flu A&B, RSV, strep
CoV-2/Flu/RSV plus – as little as 25 minutes
CoV-2 plus – as little as 20 minutes
Flu/RSV – as little as 20 minutes
Flu – as little as 20 minutes
Strep A – as little as 18 minutes
11. 5” W x 18” H* x 16” D*
Can run multiple tests at once
Can run multiple tests with 1 sample
Submit an order request form here
Visit here for produce information and here for training
The Quidel Sofia 2 is a benchtop analyzer manufactured by the Quidel Corporation that uses fluorescence detection to analyze data points in patient samples to look for markers to diagnose gastrointestinal, respiratory, vector-borne illness, and more in as little as 3 minutes. This test can also run multiple tests at once with one patient sample. This machine is CLIA waived for all tests that require a nasal or nasopharyngeal swab.
*Note that this machine requires extensive sample preparation
This machine can read results in two modes depending on workflow needs.
All Covid-19 results need to be reported according to state and national standards. More information can be found here.
See here for a video demonstration on how to use the machine
For CPT codes and reimbursement rates, visit here
Covid-19, Flu A&B, RSV, strep, Lyme, hCG, campylobacter
Fluorescent immunoassay analyzer
Yes for all except hCG, campylobacter
> 90%, varies by test
> 94%, varies by test
2 lbs, 22 cm deep x 12 cm wide x 12 cm high
$2,080.00 + varying costs of tests
2 performance modes to meet workflow needs
Submit an order request form
Visit this link for step-by-step instructions
CLINITEK Status®+ Analyzer from Siemens Medical Solutions USA, Inc. is a point-of-care urinalysis analyzer for urinalysis testing and urine hCG pregnancy testing.
It is CLIA-waived for both of these tests, is efficient, eliminates error sources and improves data integrity.
In as little as 1 minute
In as little as 5 minutes
Billing: CPT code(s) 81003QW, 82044QW, 82570QW, 84703QW for urinalysis and 84703QW for hCG
Urinalysis and Human chorionic gonadotropin (HCG)
Automated point-of-care urinalysis analyzer
Yes for both tests.
3.65 lbs, 10.70 in. deep, 6.70 in. wide x 6.20 in. high
$1,703.00 + varying costs of tests
Purchases can be done through various distributors found here.
This machine is CLIA waived for SARS-CoV-2 & Influenza A/B Nucleic Acid Test
Group A Strep
In as little as 15 minutes
C-diff, COVID-19 antigen, Influenza A&B, RSV
In as little as 20 minutes
Billing: CPT code(s) 87502QW for Influenza A&B, 87631QW for RSV, and 87651QW for Group A Streptococcus
PCR COVID-19 antigen, influenza A&B, Respiratory Syncytial Virus (RSV), Group A Streptococcus and Clostridioides difficile.
Yes, for SARS-CoV-2 & Influenza A/B Nucleic Acid Test
15 minutes for Group A Strep.
20 minutes for C-diff, COVID-19 antigen, Influenza A&B, RSV.
Sensitivity = 100%
Specificity = 97.4%
Sensitivity = 97.9%
Specificity = 97.5%
For inquiries, submit an order request form.
Small, compact design, can store up to 20,000 patient test results.
Training and videos are available.
OraSure Technologies offers three versions of rapid infectious disease tests for point-of-care diagnostics with minimal steps. The InteliSwabis used for Covid-19 testing, the ORAQUICK is used for HCV testing, and the ORAQUICK ADVANCE is used for HIV testing.
These tests do not require any external laboratory equipment, instruments, batteries, compatible technology, smart devices, or laboratory analysis. All three tests are CLIA waived.
ORAQUICK and ORAQUICK ADVANCE
Covid-19, HCV, HIV
20 minutes for HIV, HCV
30 minutes for Covid-19
98% for HIV, HCV tests
> 85% for Covid-19 tests
Pack of 25 ORAQUICK tests: $535.00
Pack of 25 ORAQUICK ADVANCE tests: $782.00
Pack of 25 InteliSwag tests: $503.00
No batteries or technology needed
Federal government’s choice of rapid covid-19 test
Visit ORAQUICK, ORAQUICK ADVANCE, IteliSwab for trainings
The Rapid Antigen Test by 20/20 Genesystems, Inc. is a serology test that detects antibodies against SARS-CoV-2 in a blood sample taken from the test subject.
CoronaCheck has various tests available such as rapid antigen, molecular and lab-based. As of October 2020, the three tests by CoronaCheck have FDA EUA Authorization.
The Antigen test is a lateral flow immunochromatographic assay
Used for the qualitative recognition of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens.
In as little as 10 minutes
(+) One red-colored line next to “C” and one blue-colored line next to “T”
(-) One red-colored line only next to “C”
COVID-19 Rapid Antigen, COVID-19 molecular test andLab-based COVID-19 antibody test
They all are FDA EUA Authorization.
$500.00 per box for 1-10 boxes
$475.00 per box for 11-25 boxes
Results appear on a test strip in 10 minutes.
Bulk Discounts Available.
Visit CoronaCheck to order.
The CardioChek Plus is a portable analyzer manufactured by PTS Diagnostics to provide rapid, on-site blood chemistry values. This machine can test lipid profiles, blood glucose, and/or both simultaneously with a single fingerstick sample of a patient’s blood.
It uses the same technology as clinical laboratories but returns results in 90 seconds. This machine is CLIA waived, meets NCEP guidelines for accuracy, is CRMLN-certified for cholesterol testing, and is FDA approved.
This machine is CLIA waived
Reflectance Test – for lipid testing
Electrochemical Test – for blood glucose
Printer – $313.00
50 pack of electrochemical test strips & MEMo chip – $87.90
Lipid Promo Pack – $931.39
Lipid panel (TC, HDL,TG), blood glucose
Calculates: LDL, non-HDL, LDL/HDL, TC/HDL
Analyzer – $1279.00 + cost of strips
Fast, portable, lab quality results
Minimal steps/equipment to use
Visit this link or email email@example.com
Follow the user guide or website for additional trainings
Sensitivity = 76%
Specificity = 93%
Sensitivity = 87%
Sensitivity = 98%
Specificity = 99%
In as little as 3 minutes
CPT code(s) 83036QW for A1C
HbA1c, Lipid Panel, ACR, and CRP.
Yes, for all
7.5 lbs, 7.2 x 7.5 x 13.0 (in)
$4,127.35 + varying costs of tests
No calibration or maintenance needed
Visit this link to submit a form for sales inquiries.
A video on how to get started can be found here.
Total Cholesterol and Triglycerides
In as little as 2 minutes
In as little as 3 seconds
Triglycerides (70-600 mg/dL)
Glucose (20-600 mg/dL)
CPT code(s) 80061QW, 82465QW, 82962QW, 83718QW, 84478QW for lipid panel and glucose
Total cholesterol, triglycerides and glucose
Blood Cholesterol Testing Device
Yes for all
3 secs – 2 minutes
282 grams, 4 x 2.5 x 1 inches
$79.00 + varying costs of tests
Small to fit in one hand
Results within seconds
this machine is CLIA waived for all tests
Spectroscopy Test – for lipid profile testing
Electrochemical Test – for blood glucose testing
CPT code(s) 82465QW for cholesterol and 84478QW for Triglycerides
Lipid panel (Cholesterol, TG), blood glucose
3 seconds – glucose
2 minutes – lipid profile
Pack of 50 blood glucose test strips: $23.50
Pack of 10 cholesterol test strips: $78.00
Pack of 10 triglyceride test strips: $78.80
fill out this form
The A1CNow®+ is a point of care system manufactured by PTS Diagnostics that provides accurate HbA1C results in 5 minutes with a mere fingerstick. This system is small, portable, easy to use, and CLIA waived.
Compatible to send data to third-party data management system and/or printer
Visit this link for more information about CPT codes and reimbursement rates.
Fast, portable, lab quality results at point of care
The Coag-Sense PT2 meter is a device manufactured by CoaguSense Inc. to measure PT and INR for patients on oral Coumadin at point-of-care. This meter provides gold-standard, accurate results in less than a minute with a fingerstick sample of blood. Additionally, this device is the only CLIA waived system to produce prothrombin time. Also, the monitor requires minimal training and steps to use, providing a more accessible, direct approach to INR monitoring.
Micro-mechanical technology measures actual clotting time for a real PT measurement
< 1 minute
Use CPT code 85610QW
Prothrombin Time, INR
Pack of 50 test strip kit: $196.90
Costs of other supplies
Only point-of-care testing system that directly detects clotting endpoint
Only CLIA-Waived system that returns a true prothrombin time
Fill out this form to contact sales
Review the quick reference guide, professional user manual, and videos
Please see this link for reimbursement rates and CPT codes
For product training, visit this link
Lipid profile, glucose
Meets NCEP, LSP, and CRMLN performance-goal standards for accuracy
Total cholesterol pack of 10 test cassettes: $106.10
Total cholesterol/glucose pack of 10 test cassettes: $106.10
Total cholesterol/HDL pack of 10 test cassettes: $204.00
Total cholesterol/HDL/glucose pack of 10 test cassettes: $215.50
Lipid profile pack of 10 test cassettes: $244.50
#1 choice used by healthcare professionals in thousands of settings nationwide
Small, portable, fast, and accurate
Watch demo videos and read helpful documents
Higi is a consumer health engagement company by Babylon health, it provides physical access through a network of digital Smart Health Stations. Complementary web and mobile tools enable a consumer’s health engagement, making it simple to understand and take action on their healthcare needs. The data it can give includes weight, blood pressure, pulse, and body mass index (BMI).
This machine is not CLIA waived
Measurements are taken from the upper arm and data is collected and sent to a mobile app. It is intended for use as a public facility.
< 3 minutes
Visit this manual on how to use Higi and frequently ask questions.
Weight, blood pressure, pulse, and body mass index (BMI).
Health station screener
440 lbs (199.6 kg)
An inquiry form must be completed to obtain the cost and see if Higi is right for you.
Easy access and data can be stored and shared with healthcare providers if desired
INSTI is an HIV-1 / HIV-2 Antibody Test manufactured by bioLytical laboratories. It is a one-time use, rapid, visually read test. Upon collection of sample, an accurate result will be available in 1 minute. It is highly specific with unparalleled accuracy when compared to standard HIV laboratory tests. (NOT APPROVED IN THE US)
HIV-1 / HIV-2 Antibody
It works by a flow-through immunoassay that detects antibodies to Human Immunodeficiency Virus (HIV) Type 1 and Type 2 using a drop of human fingerstick blood.
Not approved in the United States
Specificity > 99%
Not approved in US
Fasts and discrete tests.
Unparalleled speed and accuracy in all patient settings
Visit this link for a training video.
The ADEXUSDx® Analyzer by Omnica is a small, portable analyzer that can provide point-of-care blood analysis with ADEXUSDx® test cassettes. It can be used by healthcare professionals trained and certified to use the ADEXUSDx® System. Samples can be obtained from saliva or blood from finger stick tests with a collection device. Many tests are available for research use only and those in the market include COVID-19 and hCG.
This machine is CLIA waived for COVID-19 tests
The ADEXUSDx® COVID-19 Test is an in vitro lateral-flow immunoassay for qualitative detection of total antibodies to SARS-CoV-2 in human venous whole blood (dipotassium EDTA), plasma (dipotassium EDTA), serum, and fingerstick whole blood.
The ADEXUSDx® hCG Test is an immunoassay for the qualitative detection of human chorionic gonadotropin in human whole blood, plasma, or serum to aid in the diagnosis of early pregnancy.
ADEXUSDx® COVID-19 fingerstick method:
ADEXUSDx® COVID-19 transfer device method:
ADEXUSDx® hCG fingerstick method:
ADEXUSDx® hCG transfer device method:
15-30 minutes for COVID-19
10-30 minutes for hCG
Product resources for COVID-19 test can be found here.
COVID-19 & hCG
Yes only for COVID-19 test
COVID-19 Test starting at $250 (box of 25)
hCG Test starting at $150 (box of 25)
Easy to use with kow cost per test.
Product resources for hCG test can be found here.