Specification builder · Tier C
Real-time (quantitative) PCR system, 96-well, multi-channel fluorescence detection, open platform, in research-use (RUO) or IVD-marked versions
A real-time PCR system is a thermal cycler with a fluorescence reader that measures DNA or RNA targets as they are amplified, giving quantitative and qualitative results within 1-2 hours. Hospital and public health labs use IVD-marked versions with registered kits for viral load (HBV, HCV, HIV), TB and respiratory testing; research, pharma QC, forensic and food labs use research-use versions for gene expression, genotyping, mycoplasma, DNA quantitation and GMO testing.
Loading the builder...
Standards this specification draws on
- IEC 61010-1:2010+AMD1:2016 General electrical safety of laboratory equipment (shock, fire, mechanical hazards).
- IEC 61010-2-010:2019 Particular safety requirements for laboratory equipment for the heating of materials, covering the Peltier block and heated lid (over 100 deg C) of a thermal cycler.
- IEC 61010-2-081:2019 Particular safety requirements for automatic and semi-automatic laboratory equipment for analysis, which real-time PCR systems also declare (optics, moving lid and plate mechanisms).
- IEC 61010-2-101:2018 Particular safety requirements for in vitro diagnostic (IVD) medical equipment; applies to IVD-marked versions.
- IEC 61326-1:2020 / IEC 61326-2-6:2020 Electromagnetic compatibility of laboratory equipment; part 2-6 adds requirements for IVD medical equipment.
- DRAP Medical Devices Rules 2017 Pakistan's legal framework for registration and enlistment of medical devices and IVDs; applies when the instrument and its kits are used for patient diagnosis.
- Regulation (EU) 2017/746 (IVDR) European IVD regulation used here as a recognised reference for the IVD marking of instruments and kits.
- ISO 13485:2016 Quality management system for medical device and IVD manufacturers.
- ISO 15189:2022 Requirements for quality and competence of medical laboratories, including equipment verification, calibration and traceability.
- MIQE guidelines (Clin Chem 2009) and MIQE 2.0 (2025) Minimum information for publication of quantitative real-time PCR experiments; sets expectations for data export, efficiency and QC reporting.
- ISO 20395:2019 Requirements for evaluating the performance of quantification methods for nucleic acid target sequences (qPCR and dPCR).
- 21 CFR Part 11 / EU GMP Annex 11 Electronic records and signatures requirements for regulated (GMP, forensic) data.
Common mistakes in tenders for this equipment
- Copying one brochure's figures (for example an exact ramp rate, number of independent zones or a named optical system) so that only one brand complies; specify minimum values and accept equal or better.
- Buying a research-use instrument for a hospital lab and later finding that DRAP-registered kits are not validated on it, or that results are not legally defensible.
- Buying a 'closed' or reagent-locked system without fixing kit prices, so the lab pays high per-test prices for years after a low instrument price.
- Leaving out plastics, calibration plates, PC, UPS and a starter kit, so a new instrument stands idle for months.
- Accepting a self-test printout as installation proof instead of IQ/OQ with an independent multi-probe thermal check of block uniformity and accuracy.
- Requiring 21 CFR Part 11 software or high-resolution melt for clinical or teaching labs that do not need them, which raises price and excludes credible bidders.
- Ignoring the rest of the PCR workflow (extraction, separate pre- and post-PCR rooms, biosafety cabinet, trained staff), which causes contamination and false positives.
- Not checking that local, trained service and thermal verification tools exist in Pakistan; a failed Peltier block shipped abroad can stop testing for months.