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FAQs

Explore Common Questions About Polymedco

This Frequently Asked Questions guide provides clear answers to common inquiries about Polymedco’s diagnostic systems, including FIT, PATHFAST, ESR, QCPRP, and UPS/LIS support. It is designed to help healthcare providers and laboratory staff use these products with confidence, accuracy, and efficiency.

FIT (Fecal Immunochemical Test)

How many stool samples are required for the FIT test?
Just one sample. Polymedco’s FIT is FDA cleared for use with a single stool sample, which simplifies collection and increases patient compliance without compromising accuracy.
We strongly recommend collecting stool directly into the sampling bottle according to the instructions included with the collection kit.
No. Frozen stool is not acceptable, as freezing can degrade hemoglobin, potentially affecting test results.
Yes. The test is FDA cleared for samples collected via DRE as long as the sampling wand ridges are properly covered. However, medical opinions and insurance reimbursement policies may vary. (OC Auto Micro 80 and OC Auto Sensor Diana ONLY)
Yes. Hemorrhoids can cause intermittent bleeding, possibly resulting in a false positive FIT result. Patients should consult their healthcare provider if they know they have hemorrhoids and are unsure about collection timing.
No. The reagents use synthetic polystyrene latex and contain no natural latex. Individuals with latex allergies should still use personal protective equipment as a precaution.
There are no age restrictions listed in the package insert. However, FIT is designed to detect adult hemoglobin.
If performance is acceptable, the reagents may still be used. Please mark the boxes and monitor closely. They may not remain stable for the full duration through the expiration date on the label.
Reagents: 12 months when stored properly.
Sampling bottles: Stable through brief exposure to temperatures up to 45°C for up to three weeks.
When a positive screening FIT is followed by a screening colonoscopy, both should be covered when coded properly with relevant modifiers. Reimbursement policies are evolving, so please confirm with the payer.
Yes. The polyclonal antibodies used in OC-Auto FIT detect various hemoglobin variants including HbF, HbS, HbC, HbE, and others.
There is no data suggesting patients need to stop NSAIDs before FIT.
Possible causes include improper stool consistency, an improperly placed label preventing full puncture, or buffer removed during collection. Ensure the sample bottle contains enough buffer and the label is applied correctly.

PATHFAST System

What are the target values for the PATHFAST calibrators?
Each reagent lot has specific calibrator target values, stored on the Master Curve (MC) entry card. You can run a calibrator as a patient sample to see an approximate value, but the acceptable range is defined by the manufacturer.
No. Calibrator target values vary by reagent lot and are not interchangeable.
Yes. PATHFAST can store calibrations for multiple reagent lots simultaneously (up to three lots per assay), allowing concurrent use.
Results may be unreliable. Lipemia above 1000 mg/dL can cause interference and is beyond the validated range.
Yes. The self-check qualifies as internal QC. CAP users should define the self-check frequency during IQCP risk assessment planning.
They are part of the same complex but differ in clinical interpretation and numerical values. Only Troponin I is available for point-of-care use on PATHFAST.
PATHFAST Reagents & Auditmicro Linearity Kits: 2–8°C.
Bio-Rad Controls: −20 to −70°C.
Main Standards Linearity: −10 to −25°C.
Reagent Kit: 12.5″ × 7″ × 4.75″.
Auditmicro Linearity: 6.25″ × 3.25″ × 2.5″.
Main Standards Linearity: 4.5″ × 2.5″ × 2″.
Bio-Rad 6-pack Controls: 5.25″ × 3.5″ × 2.25″.
Up to 500 user registrations.

ESR Systems

What paper does the ESR printer use?
TP-5 paper (2¼″ × 50′) and HT-100 paper for the DPU-414 printer; both are BPA-free thermal papers with specific core and roll requirements.
Variations at higher readings are expected due to algorithm use. Larger discrepancies may indicate insufficient mixing or abnormal samples. Run samples side-by-side and ensure thorough mixing.
10 minutes total, which includes ~5 minutes of equilibration before measurement.
Typically r ≥ 0.9, slope between 0.9 and 1.2, and a y-intercept near 0.
No. ESR is a semi-quantitative test without a measured analyte concentration, so AMR verification is not required.
The Sedimat is classified by the FDA as a Class I device. CAP recognizes CLIA designations (waived/non-waived), not FDA classes.

QCPRP (Quality Control Peer Review Program)

What are the minimum computer requirements to access the QCPRP website?
Internet connection and a supported browser (Chrome 9+, Firefox 3+, Safari 4+, or Internet Explorer 9+); JavaScript must be enabled.
Likely due to security settings on the computer or network. Contact your IT department to ensure the QCPRP site is allowed.
Check spam/junk folders and allow emails from Polymedco.
Links are active for 7 days. Visit https://qcprp.polymedco.com and click “Forgot Password” to generate a new link.
Submit by the 10th of each month to be included in the peer report.
Yes. You can edit data until midnight on the 10th; overwrite incorrect entries or reset them.
It will be excluded from the current month’s Peer Data but included in the next month’s cumulative Peer Data.
Yes. One email can be linked to multiple accounts. Use “Switch Accounts” in My Account to toggle between them.
Go to the Account User tab, use the drop-down next to a user, and select “Grant Admin Privileges”.
My Account → Reports tab → choose the month from the drop-down list.
Result is outside the package insert range; confirm the correct lot number is selected.
2X: result is more than 2× the package range. ±3SD: result is beyond your lab’s mean ± 3 standard deviations.
No. Only one data point per day is accepted; enter the most appropriate value if multiple exist.
Lab report: real time. Peer reports: available on the 11th of each month.
No. Online submission replaces the paper QC form.

UPS (Uninterruptible Power Supply)/LIS

Is a UPS required for operation of any Polymedco analyzer?
Not required, but strongly recommended in areas prone to power surges.
Omron BU100SW (≈20–30 minutes runtime); Omron BU100SW + BUM100S (adds extra battery); Power Var ABCE1442-11.
No. The LIS connection should be plug-and-play from one OC Auto analyzer to another.
OC Auto Sensor io, OC Auto Sensor Diana, PATHFAST, Sediten, and Sedimat 15 Plus are LIS-compatible via RS-232C. Cables/connectors are NOT included and must be purchased separately.
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