The clinic that runs out of COVID/flu combo cassettes in the second week of January did not forget to order. It ordered the same week as every other clinic, after the distributor had put the SKU on allocation. Staff rationed tests and the practice paid spot pricing. The kits were easy to buy in September and hard to buy the week everyone needed them. Rapid test inventory is a par-level problem with a calendar attached, and the calendar is knowable.
What the CDC outlook says about this season
CDC's 2026-2027 Respiratory Disease Season Outlook puts the most likely peak combined hospitalization rate for COVID-19, influenza and RSV within 20 percent of the 2025-2026 peak, with low to moderate confidence. CDC calls it an assessment, not a forecast, and names what could move it: a SARS-CoV-2 variant with more immune escape or lower vaccine uptake.
Timing matters more to a buyer than magnitude. CDC's base scenario has COVID-19 peaking in early to mid-January, or late January 2027 if a moderate immune-escape variant emerges. Influenza historically peaks between December and February. RSV typically peaks in late December or early January, but last season it peaked in February, so CDC flags RSV timing as uncertain again.
Cover mid-December through the end of February at full par, and keep the ability to release more if RSV runs late a second year.
Match the kit to the setting before you count anything
Two questions decide the SKU list.
Who performs the test. Staff swabbing and reading the result means a CLIA Certificate of Waiver and the professional, point-of-care kit. A person testing themselves means the OTC self-test. The same brand often sells both with different labeling; the rapid diagnostic tests category separates them so the wrong version does not land in a clinic order.
How much sensitivity you need. CDC's clinician guidance puts rapid influenza antigen tests without a reader at 53 to 54 percent sensitivity against RT-PCR, with specificity of 98 percent or higher, recommends collecting specimens within 3 to 4 days of onset, and warns that false negatives rise when prevalence is high. Write the confirmatory step into the protocol now, and count the supply it consumes.
The two lines buyers ask about most:
- Healgen. The Rapid Check COVID-19/Flu A&B Antigen Test received FDA De Novo authorization on October 8, 2024, the first home flu and COVID-19 combination test authorized outside emergency use. The IFU covers self-testing at 14 and older, adult-collected samples at 2 and older, and a 15 to 20 minute read window. Keystone lists the 25-test professional kit plus Healgen RSV and Strep A cassettes.
- iHealth. FDA cleared the Flu A&B/COVID-19 Rapid Test and the professional Rapid Test Pro under 510(k) K251092 on December 12, 2025, as a Class II multi-analyte respiratory virus antigen test. Keystone lists the 2-test self-test kits by the case and the Flu A&B/COVID-19/RSV kits in 1, 2, 4 and 5-test packs.
Build the par from visits, not from last year's invoice
Last year's invoice shows what you managed to buy, not what you needed. Build the number from the visit schedule.
- Pull symptomatic respiratory visits per week from the two peak weeks last winter.
- Multiply by the share of those visits your protocol tests.
- Multiply by tests per patient, counting confirmatory and repeat tests on negatives.
- That is peak weekly burn. Par is peak burn times the weeks of cover you want on the shelf, plus external controls for each new lot.
| Setting | Kit type | Count by | Reorder trigger |
|---|---|---|---|
| Primary care, urgent care | POC COVID/Flu A&B 25-test kits, RSV for pediatric volume | Peak-week symptomatic visits x test rate | On-hand below two weeks of peak burn |
| Senior living, long-term care | POC kits for staff, OTC kits for residents and visitors | Census plus staff headcount, plus sealed outbreak reserve | Outbreak reserve is opened |
| Schools, employers | OTC 2-test kits by the case, stored centrally | Headcount x expected send-home rate | One case remaining |
| Public health, corrections intake | POC combo kits plus single-target COVID for screening | Intakes per week | On-hand below two weeks |
Then add what the cassettes do not include: external control swabs, timers, gloves, biohazard bags and the results log. A kit with no controls for the new lot is not usable inventory.
Dating, storage and the EUA sunset
Three things spoil a good par.
Storage. Healgen's IFU calls for storing the kit between 2 and 30°C (36 to 86°F) out of direct sunlight, bringing reagents and devices to room temperature (15 to 30°C) before testing, and using an opened cassette within an hour. Ranges differ by brand, so read each IFU. In practice: no cases staged on a receiving dock in January, none left in a vehicle between sites.
Dating. Ask for dating on the quote, and check the outer box before use. FDA's table of authorized at-home OTC COVID-19 tests flags which ones carry an extended expiration date and links the extension letter for each; the iHealth COVID-19/Flu A&B Rapid Test is listed with a 17 to 20 month extension. A box that looks short-dated may have months left; one that spent a summer in a hot storeroom may not.
The EUA sunset. FDA states that the HHS declarations authorizing emergency use of COVID-19 medical devices, including in vitro diagnostics, terminate effective December 26, 2026, and that EUAs for devices on its list end that day. That date sits mid-season. Get the FDA pathway on the quote for every test: 510(k) cleared, De Novo, or EUA only. A SKU can sit on FDA's EUA list and also hold a 510(k) under a newer label, as the iHealth combo test does, so the quote needs to name the cleared version. Do not carry EUA-only inventory across December 26 without a written answer from the manufacturer.
Watch the data weekly and release in tranches
CDC's Respiratory Virus Activity Levels page updates weekly with emergency department visit percentages for COVID-19, flu and RSV, test positivity and wastewater detections, by state, on a five-step scale from Very Low to Very High. The most recent three weeks are preliminary. Use it as the release trigger: when your state steps from Low to Moderate, release the next tranche.
That only works if the order was written as tranches. Lock season volume and pricing on one purchase order, then schedule monthly releases from November through February instead of one pallet in October. Stocked items ship from Edina in 1 to 3 business days, short enough to hold two weeks of peak burn rather than six.
What Keystone supplies
Keystone Supply Group quotes point-of-care and OTC respiratory antigen tests from its Edina, Minnesota office and warehouse at 7330 Ohms Lane, with Healgen and iHealth among 270+ manufacturer relationships and 58,000+ quotable SKUs. Buyers get same-day quotes during business hours, dating and FDA pathway on every line, Net 30 for approved accounts, and free economy shipping on U.S. orders of $500 or more. Send your peak-week visit count and current kit list to Orders@KeystoneSupplyGroup.com or call (507) 237-6036.
Explore the catalog to see current rapid test listings, or Request a quote for a season order with scheduled releases.
Sources
- CDC, 2026-2027 Respiratory Disease Season Outlook: https://www.cdc.gov/cfa-qualitative-assessments/php/data-research/season-outlook26-27.html
- CDC, Respiratory Virus Activity Levels: https://www.cdc.gov/respiratory-viruses/data/activity-levels.html
- CDC, Rapid Influenza Diagnostic Tests, Information for Clinicians: https://www.cdc.gov/flu/hcp/testing-methods/clinician_guidance_ridt.html
- FDA, In Vitro Diagnostics EUAs, Antigen Diagnostic Tests for SARS-CoV-2: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- FDA, At-Home OTC COVID-19 Diagnostic Tests: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests
- FDA, 510(k) K251092 Clearance Letter, iHealth Flu A&B/COVID-19 Rapid Test and Rapid Test Pro: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251092.pdf
- Healgen Scientific, Rapid Check COVID-19/Flu A&B Antigen Test Instructions for Use: https://healgen.com/wp-content/uploads/2025/09/INSTRUCTIONS-FOR-USE.pdf
- PR Newswire, Healgen Scientific Receives FDA De Novo Marketing Authorization for At-Home COVID-19 and Influenza Test: https://www.prnewswire.com/news-releases/healgen-scientific-receives-fda-de-novo-marketing-authorization-for-at-home-covid-19-and-influenza-test-302269927.html
