Prolex™ Streptococcal Grouping — The Only Peer-Reviewed Validated Strep Grouping Kit
99% sensitivity. 100% specificity. Results in 60 seconds. Groups A, B, C, D, F, and G. The only strep grouping kit independently validated in a peer-reviewed head-to-head study across 302 clinical isolates.
Sensitivity
99%
Specificity
100%
Result Time
60s
Clinical Sensitivity
Independent study, 302 consecutive clinical isolates. British Journal of Biomedical Science.
Clinical Specificity
Zero false positives in peer-reviewed independent comparative study. No retest cascade.
Rapid Results
At room temperature. No incubation required. Agglutination time substantially faster than 3 of 4 comparator kits (PMID 14560788).
The Evidence No Competitor Can Match
Most streptococcal grouping kits are validated by the manufacturer who sells them. Prolex is different. In 2003, independent researchers evaluated five commercially available strep grouping kits head-to-head across 302 consecutive clinical isolates — every major kit on the market at the time.
Prolex achieved 99% sensitivity and 100% specificity — with agglutination times substantially faster than three of four comparator kits. Published in the British Journal of Biomedical Science and indexed on PubMed. No other commercial strep grouping kit has an equivalent independent publication.
"Prolex-Blue proved to be both accurate and rapid."
— Davies et al., Br J Biomed Sci. 2003;60(3):136-40. PMID: 14560788.
Peer-Reviewed Validation
302 consecutive clinical isolates. Independent UK study. Five kits head-to-head. PMID: 14560788.
60-Second Results
Modified acid extraction. Room temperature. No incubation. Fits standard microbiology workflow.
All 6 Lancefield Groups
Complete coverage: A, B, C, D, F, and G. Color-coded reagents. Blue latex on white card.
Direct Pricing
$453.32 direct vs. $863.93 at Hardy Diagnostics for equivalent chemistry. 47% savings.
Comparative Clinical Analysis
Independent data vs. manufacturer-reported claims.
| Feature | Prolex™ PL.030 | PathoDxtra (Thermo) | Hardy StrepPRO |
|---|---|---|---|
| Independent Peer-Reviewed Study | check_circle Yes — PMID 14560788 | ✗ Manufacturer only | ✗ Manufacturer only |
| Sensitivity | 99% (independent) | Manufacturer-reported | >98% (manufacturer) |
| Specificity | 100% (independent) | Manufacturer-reported | Manufacturer-reported |
| Groups A–G | check_circle Yes | Yes | Yes |
| Result Time | 60 seconds | ~60 seconds | ~60 seconds |
| CE Marked | check_circle Yes | Yes | ISO 13485 / 17025 |
| Direct Price / Kit | $453.32 | Contract pricing | $863.93 |
Precision for Every Lab Role
CAP-Defensible Evidence — Not Just Manufacturer Claims
When a CAP inspector asks why you chose your strep grouping kit, "the Thermo rep recommended it" isn't the answer. Prolex is backed by an independent, peer-reviewed head-to-head comparison — the kind of evidence that holds up in an audit.
- check_circle99% sensitivity / 100% specificity — independent study, 302 clinical isolates (PMID 14560788)
- check_circleCE Marked IVD. ISO 13485 certified manufacturer.
- check_circlePerformance data sourced from independent researchers — not from Pro-Lab Diagnostics.
- check_circleAll Lancefield groups A, B, C, D, F, G — complete coverage for outbreak investigation.
The Published Evidence
Davies S, Gear JE, Mason CM, McIntyre SM, Hall L. Streptococcus grouping latex kits: evaluation of five commercially available examples. Br J Biomed Sci. 2003;60(3):136-40. PMID: 14560788.
302 consecutive clinical isolates. All five major commercial kits tested head-to-head by independent UK NHS researchers. Prolex-Blue: 99% sensitivity. 100% specificity. Fastest agglutination of four comparator kits.
Fewer Retests. Faster Bench. Lower Cost Per Test.
100% specificity means no false positives to chase down. No retest cascade. No supervisor review for an ambiguous result that turns out to be negative.
- check_circle100% specificity — eliminates false positive retests (PMID 14560788)
- check_circle60-second result at room temperature — no incubation required
- check_circle60 tests per kit — 48 agglutination cards and 350 mixing sticks included
- check_circleAll individual components available separately — no waste from partial kits
Cost Per Test
$453.32 ÷ 60 tests per kit
Clear Reads in 60 Seconds. No Ambiguity.
Blue carboxylated latex particles on a white reaction card. If it clumps, it's positive. If it doesn't, it's negative. The highest-contrast read available in this category.
- check_circleHigh-contrast blue on white — unambiguous agglutination reading
- check_circleColor-coded reagent labels and caps — right reagent, right group, every time
- check_circleDropper bottle format — easy dispensing, no pipetting required
- check_circle1-minute result at room temperature — no incubation, no waiting
4-Step Procedure
- 1Extract antigen using nitrous acid extraction reagents (Steps 1–3, ~5 min)
- 2Transfer extracted antigen to agglutination card
- 3Add appropriate group-specific latex reagent
- 4Rock gently — read at 1 minute. Agglutination = positive.
Same Performance. 47% Lower Cost.
Hardy Diagnostics StrepPRO (PL030HD): $863.93 for equivalent chemistry. Prolex™ PL.030 direct: $453.32. That's $410.61 per kit in savings buying direct from the manufacturer.
- check_circleISO 13485 certified manufacturer
- check_circleCE Marked IVD
- check_circleAlso available via Fisher Scientific (22-286-175) for PO-based purchasing
- check_circleNet 30 available for qualifying institutions — request a volume quote
Price Comparison
People Also Purchased
Complete your gram-positive ID panel — all available from Pro-Lab Diagnostics.
PL.080B / PL.1081
Prolex™ Staph Latex Kits
Rapid latex detection of S. aureus and MRSA — same Pro-Lab latex agglutination platform, ordered by the same clinical micro labs.
View Staph Kit →
PL.300 / PL.301
Rabbit Coagulase Plasma
Tube coagulase confirmation for S. aureus — frequently used in the same gram-positive ID workflow as Strep grouping.
View Rabbit Coagulase →
PL.390
TestOxidase™ Cytochrome Oxidase Reagent
Oxidase spot test used in the same multi-organism identification workflow alongside Lancefield grouping.
View TestOxidase™ →
PLD001 / PLD010
Pro-Loops™ Calibrated Inoculation Loops
Sterile single-use loops for colony transfer to the Prolex Strep slide agglutination — same order, same vendor.
View Pro-Loops™ →Technical Specifications
Frequently Asked Questions
What Lancefield groups does the Prolex kit detect?
Prolex™ PL.030 detects Lancefield groups A, B, C, D, F, and G — all six clinically relevant beta-hemolytic streptococcal groups — in a single complete kit.
How long does it take to get a result?
Results are obtained within one minute at room temperature. No incubation step is required for the acid extraction method (PL.030).
Is the Prolex strep grouping kit peer-reviewed?
Yes. Prolex is the only commercial strep grouping kit independently validated in a peer-reviewed, head-to-head study. Davies et al. evaluated five commercial kits across 302 consecutive clinical isolates — Prolex-Blue achieved 99% sensitivity and 100% specificity. Published in the British Journal of Biomedical Science. PMID: 14560788.
What is the sensitivity and specificity?
In the independent peer-reviewed study: 99% sensitivity and 100% specificity across 302 consecutive clinical isolates. This data was generated by independent researchers — not by Pro-Lab Diagnostics.
Does Prolex require an incubation step?
No. The acid extraction method (PL.030) delivers results at room temperature in 1 minute with no incubation. The enzyme variant (PL.1050) uses a 10-minute incubation. For fastest bench turnaround, PL.030 is recommended.
What is the difference between PL.030 and PL.1050?
PL.030 uses modified nitrous acid extraction — no incubation, results in 1 minute. PL.1050 uses enzyme extraction requiring a 10-minute incubation. Both detect Groups A, B, C, D, F, and G. PL.030 is the primary validated kit (PMID 14560788 tested the acid extraction method).
Is the Prolex kit CE Marked?
Yes. Prolex™ is CE Marked for in vitro diagnostic use. Pro-Lab Diagnostics is ISO 13485 certified.
How does Prolex compare to PathoDxtra?
Prolex has an independent peer-reviewed study (PMID 14560788) showing 99% sensitivity and 100% specificity across 302 isolates. PathoDxtra's performance data comes from manufacturer-produced marketing materials — not independently peer-reviewed. For CAP audit purposes, the independent data in PMID 14560788 is the evidence that stands up to scrutiny.
What is the cost per test?
At $453.32 per 60-test kit, the cost per test is approximately $7.56.
What is the shelf life of the Prolex strep grouping kit?
All kit components are stable until the expiry date printed on the product label when stored at 2–8°C. Do not freeze. Do not use reagents after the expiration date shown on the product label (IFU PL041_en05, Rev. 2023-01).
What quality controls are required?
The kit includes a Polyvalent Positive Control (PL.040) for routine QC of all six latex reagents. Per IFU, quality control testing uses the following ATCC reference strains: S. pyogenes ATCC 19615 (Group A), S. agalactiae ATCC 12386 (Group B), S. dysgalactiae subsp. equisimilis ATCC 12388 (Group C), Enterococcus faecalis ATCC 19433 (Group D), Streptococcus sp. type 2 ATCC 12392 (Group F), and S. dysgalactiae subsp. equisimilis ATCC 12394 (Group G).
Can I buy individual Prolex reagents separately?
Yes. All individual kit components — latex reagents for each group, extraction reagents, agglutination cards, and mixing sticks — are available for separate purchase. Contact us for component pricing.
Switch to the Validated Standard.
99% sensitivity. 100% specificity. Independent peer-reviewed data. Order direct at $453.32 or request volume pricing for your institution.
Ships cold from Georgetown, Texas · 2-day delivery