Confirm O157 & All 6 Non-O157 STEC Serogroups at the Bench
Non-O157 STEC causes 65–70% of US STEC infections. Complete your STEC panel: Prolex™ PL.070B/071B for O157 and PL.1070 for all 6 USDA Big 6 Non-O157 serogroups — same-day results from a direct colony.
Serogroups Identified by PL.1070
O26
O45
O103
O111
O121
O145
All 6 USDA-declared adulterant STEC serogroups. One kit.
30 sec
Non-O157 result
50
Tests / kit
CE
Marked IVD
USDA-Regulated Serogroups
O26, O45, O103, O111, O121, O145 — all identified in a single complete kit. No ordering 6 separate antisera.
Non-O157 Result Time
PL.1070 Non-O157 kit: result within 30 seconds from colony on selective agar. O157 kits (PL.070B/071B): result within 2 minutes.
of US STEC Infections
Caused by non-O157 serogroups (est., CDC FoodNet). O157-only testing misses the majority of your STEC-positive specimens.
Most Labs Are Only Seeing One-Third of Their STEC Cases
E. coli O157:H7 gets the press coverage. But CDC surveillance data consistently shows that non-O157 STEC serogroups — O26, O45, O103, O111, O121, and O145 — cause an estimated 65–70% of all STEC infections in the United States.
USDA FSIS recognized this problem in 2012 when they declared these same six serogroups as adulterants in non-intact raw beef. Food safety labs have tested for all six ever since. Clinical labs are still catching up — most still send non-O157 suspects to the state reference lab and wait 3–7 days.
Prolex™ PL.1070 closes the gap. Direct colony. 30-second result. Same day as the culture.
"North America's six most common STEC-producing serotypes."
— Pro-Lab Diagnostics product description. O26, O45, O103, O111, O121, O145.
USDA Big 6 — Regulatory Mandate
USDA FSIS declared O26, O45, O103, O111, O121, O145 as adulterants in non-intact raw beef in June 2012 (Federal Register 77 FR 31975). Mandatory testing in food production labs since then.
Clinical Impact
Non-O157 STEC causes hemorrhagic colitis and HUS — same clinical syndromes as O157. Serogroup confirmation required for outbreak attribution and public health reporting.
The Reference Lab Gap
Typical reference lab serotyping turnaround: 3–7 days. By then, the patient is often discharged and the outbreak window is closing. PL.1070 closes the gap with a 30-second bench result.
One Complete Kit
All 6 serogroup-specific latex reagents + positive control + agglutination cards + mixing sticks. Single SKU. No sourcing complexity. 50 tests per kit.
4 Steps. Same-Day Serogroup.
From colony on plate to confirmed serogroup — within 30 seconds at room temperature. No enrichment. No special equipment.
Pick a Colony
Take a single colony directly from selective agar — SMAC, Rainbow Agar, CT-SMAC, or equivalent. No enrichment required.
Apply to Card
Transfer and emulsify the colony in the agglutination card circles using a mixing stick — one circle per serogroup being tested.
Add Latex Reagent
Add one drop of each serogroup-specific latex reagent (O26, O45, O103, O111, O121, O145) to its circle on the card.
Rock and Read
Rock gently and read within 30 seconds. Do not read after 30 seconds. Visible agglutination in a circle = positive for that serogroup. Report same day.
The Right Fit for Every Lab Role
Complete Your STEC Reporting. Don't Make Clinicians Wait a Week.
When a non-O157 STEC case comes in, your clinician and your state health department need serogroup data to manage the patient and investigate the outbreak. Waiting 3–7 days for a reference lab result is a preventable delay. PL.1070 gives you a reportable serogroup within 30 seconds — same day the culture grows.
- check_circleCE Marked IVD. ISO 13485 manufacturer. CAP-defensible documentation available.
- check_circleAll 6 USDA-regulated serogroups in one kit — no component ordering complexity.
- check_circleSame Prolex latex agglutination platform as O157 kits — familiar workflow to validate.
- check_circlePresumptive serogroup same day; send confirmed positives for WGS/PFGE confirmation.
The Non-O157 STEC Gap
Without PL.1070
Non-O157 suspect → ship to reference lab → wait 3–7 days → receive serogroup → report to public health
With PL.1070
Non-O157 suspect → 30-second bench test → serogroup confirmed → report same day → send for WGS
Fewer Reference Lab Shipments. Faster Reporting. Less Coordination.
Every non-O157 STEC suspect you ship to the state lab requires packaging, chain-of-custody forms, and waiting. PL.1070 puts first-pass serogroup at the bench within 30 seconds. You still send confirmed positives for WGS — you just don't send every suspect.
- check_circle30-second result eliminates same-day reference lab shipping pressure
- check_circle50-test kit handles typical clinical lab STEC volumes all season
- check_circleOne-step reagent addition per serogroup — minimal bench time per specimen
- check_circleProlex platform: familiar if lab already uses strep or staph latex kits
Cost Per Test Estimate
Contact us for current direct pricing. 50 tests per kit.
USDA Big 6 Compliance. Rapid Presumptive Screen.
USDA FSIS requires testing for all 6 non-O157 STEC serogroups in non-intact beef products. PL.1070 provides a rapid presumptive screen — within 30 seconds per isolate — that identifies presumptive positives for confirmatory PCR. Route negatives out of the expensive pipeline early.
- check_circleCovers all 6 USDA FSIS-regulated serogroups: O26, O45, O103, O111, O121, O145
- check_circleCE Marked IVD; ISO 13485 — regulatory documentation for FSMA compliance file
- check_circleScreen first, confirm only positives — reduce PCR confirmatory volume and cost
- check_circleComplete kit format: consistent reagent lots across all 6 serogroups
USDA FSIS Background
In June 2012, USDA FSIS declared O26, O45, O103, O111, O121, and O145 as adulterants in non-intact raw beef products under the Federal Meat Inspection Act (Federal Register 77 FR 31975). Beef products positive for these serogroups are subject to recall.
PL.1070 is a presumptive identification method. Confirmatory testing per USDA FSIS MLG protocol is still required for regulatory reporting and recall actions.
One SKU. One PO Line. All Six Serogroups Covered.
Sourcing non-O157 STEC reagents through distribution means managing 6+ individual antisera SKUs, plus cards, mixing sticks, and positive controls as separate line items. PL.1070 consolidates everything into a single kit — consistent lot numbers, single vendor, single order.
- check_circleSingle kit format: no multi-SKU sourcing complexity
- check_circleISO 13485 certified manufacturer — GMP-compliant supply chain documentation
- check_circleNet 30 available for qualifying institutions
- check_circleVolume pricing available on request — contact for institutional quote
Sourcing Comparison
Order Prolex™ E. coli STEC Kits Direct
Complete E. coli STEC panel — O157 and all 6 Non-O157 serogroups. Factory direct from Georgetown, TX.
Prolex™ E. coli O157 Latex Test Kit
Identifies E. coli O157:H7 and O157:NM from direct colony. CE + UKCA Marked IVD. 50 tests per kit.
Prolex™ E. coli O157 Latex Test Kit (100T)
Same O157 latex agglutination kit in a larger 100-test format for higher-volume labs. CE + UKCA Marked IVD.
Prolex™ E. coli Non-O157 STEC Kit
All 6 USDA Big 6 serogroups (O26, O45, O103, O111, O121, O145) in one kit. 30-second result. CE + UKCA Marked IVD.
Prolex™ PL.1070 vs. Alternative Methods
How non-O157 STEC serogroup confirmation approaches compare.
| Feature | Prolex™ PL.1070 | Individual Antisera | Reference Lab | PCR (Stx) |
|---|---|---|---|---|
| Serogroup Confirmation | check_circleAll 6 (O26–O145) | Yes — 1 per reagent tube | Yes — complete O:H | Stx genes only — no serogroup |
| Result Time | within 30 seconds | 2–5 min | 3–7 days | 1–4 hours |
| Cost Per Test | Contact for direct pricing | ~$80–$120/serogroup × 6 | $50–$100+ + shipping | $50–$150 |
| Kit Format | check_circleComplete kit — 1 SKU | Individual — 6+ SKUs | Send-out service | Cartridge/panel |
| Infrastructure | check_circleNone | None | Shipping account | PCR instrument required |
| CE Marked IVD | check_circleYes | Varies | N/A | Yes |
| Factory Direct | check_circleYes | Distributor only | N/A | No |
People Also Purchased
Frequently ordered together in enteric pathogen and food safety microbiology labs.
PLA-Series
Pro-Lab Enteric Pathogen Antisera
Salmonella, Shigella, Vibrio, and pathogenic E. coli antisera for serological confirmation after STEC latex screening.
View Antisera →
PL.030
Prolex™ Streptococcal Grouping Kit
Latex agglutination for Lancefield groups A–G — same Pro-Lab latex platform, frequently ordered by the same labs.
View Strep Kit →
PLD001 / PLD010
Pro-Loops™ Calibrated Inoculation Loops
Sterile single-use plastic loops for colony transfer — required for slide agglutination testing with both E. coli and antisera kits.
View Pro-Loops™ →Technical Specifications
All three Prolex™ E. coli kits use the same latex agglutination platform — same workflow, same CE + UKCA regulatory status.
Companion O157 Kits — PL.070B & PL.071B
| Specification | PL.070B | PL.071B |
|---|---|---|
| Target | E. coli O157:H7 and O157:NM | |
| Tests per kit | 50 | 100 |
| Result time | within 2 minutes at room temperature | |
| Method | Latex agglutination — direct colony | |
| Storage | 2–8°C; do not freeze | |
| Regulatory status | CE + UKCA Marked IVD / ISO 13485 | |
| Price / Kit | $196.71 (~$3.93/test) | $282.24 (~$2.82/test) |
Frequently Asked Questions
What serogroups does Prolex™ PL.1070 detect?
PL.1070 identifies the six most common non-O157 STEC serogroups in North America: O26, O45, O103, O111, O121, and O145. These are the same serogroups USDA FSIS declared as adulterants in non-intact raw beef products in 2012.
How long does it take to get a result?
Results are obtained within 30 seconds from a single colony taken directly from selective agar at room temperature. Do not read after 30 seconds. No enrichment culture or additional processing is required.
What is the USDA Big 6?
In June 2012, USDA FSIS declared six non-O157 STEC serogroups — O26, O45, O103, O111, O121, and O145 — as adulterants in non-intact raw beef products under the Federal Meat Inspection Act. This made routine testing for these serogroups mandatory for food production facilities. The same six serogroups are also the most common non-O157 STEC strains in clinical human infections (CDC FoodNet data).
Is PL.1070 CE Marked?
Yes. Prolex™ is CE Marked for in vitro diagnostic use. Pro-Lab Diagnostics is ISO 13485 certified. Documentation package available for your CAP procedure manual or compliance file.
Does PL.1070 replace reference lab serotyping?
No — PL.1070 provides rapid presumptive serogroup identification (O26–O145) at the bench level. Confirmed positive isolates should still be forwarded to a reference lab for definitive O:H serotyping and WGS/PFGE characterization as required by your lab's protocols and applicable regulatory requirements. PL.1070 provides same-day presumptive data so clinical decisions don't have to wait 3–7 days for the reference lab result.
What is included in the kit?
PL.1070 includes six serogroup-specific latex reagents (O26, O45, O103, O111, O121, O145), a positive control, agglutination cards, and mixing sticks — everything required for 50 tests in one complete kit.
What selective agars are compatible?
PL.1070 works directly from colonies on selective agars used for STEC isolation, including sorbitol MacConkey agar (SMAC), Rainbow Agar, and CT-SMAC. Apply a single suspect colony directly to the agglutination card. Consult the current IFU for the complete list of compatible agars and quality control requirements.
How does PL.1070 compare to PCR methods?
PCR methods (BioFire FilmArray, Diagenode, in-house assays) typically detect Shiga toxin genes (Stx1/Stx2) rather than serogroup-specific antigens. While PCR is highly sensitive for Stx detection, it does not identify the serogroup directly. PL.1070 provides serogroup-level identification (O26, O45, etc.) within 30 seconds — faster than most PCR workflows and at lower cost per test. For laboratories using PCR for Stx detection, PL.1070 adds the serogroup dimension to specimens that are stx-positive.
Same-Day STEC Serogroup. Without the Reference Lab Wait.
Prolex™ PL.1070 covers all six USDA-regulated non-O157 STEC serogroups in one kit. 30-second latex result from a direct colony. CE Marked. ISO 13485. Factory direct pricing.
Ships cold from Georgetown, Texas · CE Marked IVD · ISO 13485