Question 1

How should FebriDx tests be stored?

Accepted Answer

Store at room temperature between 39-77°F (4-25°C). Tests are individually packaged in sealed pouches that protect against humidity. Stable until the expiration date printed on packaging. Humidity tolerance: 5-85% relative humidity. Altitude tolerance: 0-2000 meters.

Question 2

Do I need any equipment?

Accepted Answer

No. FebriDx is a fully self-contained, instrument-free test. No readers, analyzers, or external equipment required. The device includes a built-in lancet, blood collection tube, test strip, and buffer. Materials not provided: timer, gauze, alcohol wipe, sterile dressing, and external controls.

Question 3

What comes in each kit?

Accepted Answer

Each kit (Part Number CP0014) contains 25 individually sealed single-use test devices, a Package Insert, and a Quick Reference Instruction card. External controls (1 positive, 1 negative, 44 pipettes) are ordered separately under Part Number CP0007.

Question 4

Is FebriDx a single-use device?

Accepted Answer

Yes. Each device is single-use with no reusable components. Do not use on more than one patient. The test is designed to proceed in sequential order with locking mechanisms to prevent skipping steps.

Question 5

Who is eligible for testing?

Accepted Answer

Patients aged 12-64 in urgent or emergency care settings with acute respiratory infection symptoms for less than 7 days and within 3 days of fever onset.

Question 6

Can FebriDx be used on children under 12?

Accepted Answer

No. Clinical performance has not been established in pediatric patients younger than 12 years old. The FebriDx test should not be used in this population.

Question 7

Can FebriDx be used on patients over 64?

Accepted Answer

Clinical performance has not been established in elderly patients above 64 years old. The test should not be used in this population.

Question 8

Are there patients who should NOT be tested?

Accepted Answer

Clinical performance has not been established in: immunosuppressed patients, those receiving anti-infective or interferon therapy, patients who received live viral immunization within 30 days, patients with chronic symptoms or fevers lasting more than 7 days, and patients without symptoms of acute respiratory infection.

Question 9

What sample type is required?

Accepted Answer

Only fresh fingerstick capillary blood. Venous whole blood, serum, and plasma cannot be used with the FebriDx test. The blood collection tube must be filled completely for accurate results.

Question 10

How long until results are ready?

Accepted Answer

Results are readable after 10 minutes with a clear background. Results remain stable for up to one hour. Do not read results before blood clears the Result Window or after 1 hour.

Question 11

What if the result line is faint?

Accepted Answer

Faint, incomplete, or uneven result lines still indicate the positive presence of MxA and/or CRP proteins. As long as the blue control line is present, the test is valid.

Question 12

What makes a test invalid?

Accepted Answer

The absence of the blue control line indicates an invalid result. Discard the test and retest the patient with a new FebriDx test.

Question 13

Can users with color-impaired vision interpret results?

Accepted Answer

No. Interpretation of FebriDx test results involves visual assessment of colored result lines (black, red, and blue). Users with color-impaired vision should not interpret the test. A brightly lit environment is recommended.

Question 14

What is the clinical sensitivity?

Accepted Answer

In the DISRUPT clinical trial (20 U.S. sites, 520 ARI patients), FebriDx demonstrated 93.2% Positive Percent Agreement (sensitivity) for detecting bacterial infections, with a 95% confidence interval of 84.9-97.0%.

Question 15

What is the negative predictive value (NPV)?

Accepted Answer

98.7% (374/379), meaning if FebriDx says non-bacterial, there is a 99% chance that the infection is truly non-bacterial. This allows confident withholding of antibiotics.

Question 16

What biomarkers does FebriDx detect?

Accepted Answer

FebriDx simultaneously detects two host-response proteins: CRP (C-Reactive Protein) at approximately 20 mg/L serum equivalent, and MxA (Myxovirus Resistance Protein A) at approximately 40 ng/mL. Neither alone is sufficient — the combination delivers the accuracy.

Question 17

Can Rheumatoid Factor affect results?

Accepted Answer

Yes. Interference testing indicated Rheumatoid Factor may contribute to false negative and false positive results at levels above 50 IU/mL.

Question 18

What is the reimbursement rate?

Accepted Answer

CMS has set a reimbursement rate of $41.38 per test under CPT code PLA 0442U, effective January 2025. At a practitioner cost of $18-22 per test, this provides positive unit economics on every test performed.

Question 19

What CPT code do I use?

Accepted Answer

FebriDx is billed under CPT code PLA 0442U. This is a Proprietary Laboratory Analyses code specific to the FebriDx assay. Contact our billing support team for assistance with payer submission.

Question 20

Is FebriDx covered by insurance?

Accepted Answer

Medicare coverage is established at $41.38 per test. Private payer coverage is expanding. We provide billing support and Letter of Medical Necessity templates to help with prior authorization when needed.

Question 21

Is FebriDx FDA cleared?

Accepted Answer

Yes. FebriDx received FDA 510(k) clearance for marketing in the United States, and subsequently received a CLIA waiver, allowing use in point-of-care settings without a moderate or high-complexity CLIA certificate.

Question 22

Can FebriDx be used for home testing?

Accepted Answer

No. FebriDx is for professional use only. It is not for home or self-testing. Rx only.

Everything you need to succeed with FebriDx

Training Video

Product Brochure

Instructional Guide

JAMA Network Open Publication

FDA CLIA Waiver Secured

Quick Reference Instructions

Letter of Medical Necessity

Billing & Reimbursement Guide

Frequentlyaskedquestions