Poclight C5000 Immunoassay Menu: What Tests Can It Run in 2026?

The Poclight C5000 runs sandwich, competitive immunoassay formats on a homogeneous chemiluminescence platform. Its menu spans inflammation, cardiac, thyroid, tumor marker, hormone and fertility, diabetes, bone metabolism, anemia, allergy, and preeclampsia testing. The 2026 menu reflects 50+ validated assays across 10 clinical panels, plus 6 pipeline assays listed as coming soon. For readers asking which types of immunoassays can be performed on the C5000, the answer is three distinct formats supported by this compact analyzer.

Key Takeaways

• The C5000 runs Two immunoassay formats: sandwich, competitive.
• The 2026 menu includes 50+ validated tests across 10 clinical areas, such as inflammation, cardiac, and thyroid.
• Choosing the right assay format helps labs match tests to their workflow and clinical needs.

Which Types of Immunoassays Can Be Performed on the C5000?

The Poclight C5000 uses CRET-based homogeneous chemiluminescence immunoassay technology for quantitative biomarker testing. Its clinical menu covers areas including inflammation, cardiac markers, thyroid function, reproductive hormones, diabetes, and nutritional assessment.

To understand how these tests work, it is useful to distinguish the immunoassay design from the detection workflow. Terms such as sandwich and competitive describe how antibodies and analytes interact. Homogeneous CLIA describes how the analytical signal is measured without conventional bound/free separation and washing steps.

Sandwich Immunoassays

A sandwich immunoassay typically uses two antibodies that recognize different accessible epitopes on the same analyte. Formation of the antibody–analyte–antibody complex enables quantitative measurement. Within the assay’s validated measuring range, the analytical response generally increases as analyte concentration increases.

Sandwich designs are widely used for protein and peptide biomarkers. Poclight’s published descriptions identify its insulin and PlGF assays as dual-site, or sandwich, assays using homogeneous CRET technology. The reaction principle of each additional C5000 assay should be confirmed in the corresponding reagent instructions for use.

A sandwich structure does not inherently require solid-phase capture or magnetic-bead washing. In Poclight’s published CRET principle, target binding brings antibody-associated DNA components into proximity, enabling downstream signal generation and discrimination within a homogeneous reaction system.

Two-site recognition can contribute to analytical specificity, but assay performance must be established through validation. Sensitivity, precision, measuring range, cross-reactivity, and susceptibility to high-dose effects are properties of the individual reagent system and cannot be assumed from the sandwich format alone.

Competitive Immunoassays

Competitive immunoassays measure an analyte through competition for a limited number of binding sites. In a common design, the analyte in the sample competes with a labeled analyte or analogue for antibody binding. The measured response generally decreases as sample analyte concentration increases.

Competitive designs are commonly used for small-molecule targets, including thyroid hormones, steroid hormones, and vitamin D metabolites, for which conventional two-antibody sandwich designs may be difficult to construct.

The C5000 menu includes thyroid hormone, steroid hormone, and vitamin D assays. However, the specific reaction design, labeling strategy, and signal relationship of each C5000 reagent should be taken from its instructions for use rather than inferred solely from the analyte’s molecular size or clinical category.

Homogeneous CRET Detection on the C5000

The C5000 combines immunoassay reagents with CRET-based homogeneous chemiluminescence detection. In Poclight’s described system, acridinium ester provides the chemiluminescent signal and graphene oxide acts as a quencher. The assay chemistry enables signal discrimination without a conventional magnetic-bead separation and washing sequence.

The platform provides seven independent detection channels, with assay times commonly ranging from 3 to 15 minutes and a stated maximum throughput of up to 80 tests per hour. Individual assay times and achievable throughput should be considered when planning the laboratory workflow.

These operating characteristics belong to the complete instrument–reagent system. They should not be attributed solely to antibody excess or to a particular immunoassay format.

Selecting C5000 Tests for a Laboratory Workflow

Laboratories should select tests according to clinical demand, the locally available reagent menu, and the requirements of each assay.

Whole blood, serum, and plasma compatibility varies by assay. Support for a specimen type on one C5000 reagent should not be extended to the entire menu. Measuring ranges, sample volumes, and interference limits must likewise be checked individually.

To discuss a suitable C5000 configuration, contact Poclight with your country, institution type, and required biomarkers. The team can help confirm the locally available test menu and discuss instrument, reagent, and quotation requirements.

2026 Test Menu by Clinical Category

The 2026 C5000 menu organizes 50+ validated assays into 10 clinical panels. Each panel answers a defined set of clinical questions. The sections below walk through the menu category by category. They connect each assay group to its decision limits, guideline context, and operational profile.

Inflammation and Cardiac Markers

Six inflammation assays anchor the first panel. CRP and SAA run in 3 minutes on 5 µL of serum, plasma, or whole blood. CRP covers 0.5 to 320 mg/L with a cut-off of ≤10.0 mg/L. SAA covers 3 to 200 mg/L with a cut-off of ≤6.4 mg/L. IL-6 extends the panel into cytokine measurement. That assay takes 15 minutes and covers 1.5 to 5000 pg/mL. PCT delivers a 5-minute result across 0.02 to 100 ng/mL. KL-6 covers 50 to 5000 U/mL for interstitial lung disease assessment. HBP runs on plasma with a 5.9 to 300 ng/mL range.

The cardiac panel adds six assays. D-dimer runs in 5 minutes on 50 µL of plasma and covers 0.25 to 20 mg/L. BNP and NT-proBNP both report in 5 minutes. NT-proBNP covers 15 to 35,000 pg/mL. CK-MB and myoglobin carry sex-specific cut-offs. CK-MB lists 4.87 ng/mL for males and 3.61 ng/mL for females. Myoglobin lists 28 to 72 ng/mL for males and 25 to 58 ng/mL for females. hs-cTnT runs in 10 minutes on 200 µL and covers 5 to 10,000 ng/L.

Decision limits matter more than raw ranges for these markers. The table below collects the numeric limits that shape clinical interpretation in 2026.

The C5000 NT-proBNP cut-off of 125 pg/mL matches the younger-age threshold. The 15 to 35,000 pg/mL measuring range holds the 450 pg/mL older-age threshold with room to spare. The hs-cTnT assay lists a cut-off of ≤14 ng/L. Laboratories must confirm their own assay-specific 99th percentile URL before they adopt a 0/1-hour pathway.

Guidelines position each cardiac marker inside a specific clinical pathway. The table below summarizes the recommendations that matter most for menu planning.

Several interpretive cautions follow from this evidence base.

• Troponin is an acute-care marker for myocardial injury inside a time-sensitive pathway. It requires assay-specific thresholds, symptom timing, serial change, ECG, and clinical assessment. It is not a self-directed chest-pain screen.
• A normal outpatient troponin result must not be used to conclude that chest pain is safe. Emergency symptoms require immediate clinical evaluation.
• BNP and NT-proBNP support clinician-directed evaluation of suspected heart failure or cardiac wall stress. Values are assay-specific and not interchangeable. Interpretation depends on symptoms, examination, kidney function, rhythm, body size, and medicines.
• hs-CRP should not enter every heart panel. It may refine risk in selected stable adults. It is nonspecific and rises with many inflammatory conditions. Order it only when the result could change a decision.
• Advanced and emerging tests are specialist-directed. More detail does not automatically improve outcomes.

The C5000 hs-cTnT assay fits the serial-sampling model. Its intended use notes that cTnT appears early in circulating blood and lasts nearly two weeks. Detection shortens observation time and accelerates confirmation or exclusion of acute myocardial infarction. International guidelines list AMI diagnosis as a Class I, Class A recommendation. The C5000 still lists CK-MB and myoglobin, and laboratories use both for tasks outside the ACS diagnostic pathway, such as infarct monitoring and reinfarction detection.

Thyroid, Hormone, and Fertility

Five thyroid assays form the second panel. FT4, FT3, TT4, and TT3 each run in 5 minutes on 50 µL. FT4 covers 0.5 to 100 pmol/L with a reference interval of 12 to 22 pmol/L. FT3 covers 0.6 to 50 pmol/L with a reference interval of 3.1 to 6.8 pmol/L. TT4 covers 5.4 to 320 nmol/L. TT3 covers 0.3 to 10 nmol/L. TSH runs in 10 minutes and covers 0.005 to 100 µIU/mL, a range wide enough for both suppressed and markedly elevated values.

Comprehensive 2026 immunoassay menus group thyroid and fertility tests in a consistent way. The table below shows the common grouping.

On a fully automated CLIA platform, assays such as TSH, FT3, FT4, TT3, TT4, Anti-TPO, Anti-Tg, and Tg can help laboratories build a more complete endocrine and thyroid testing menu.

The C5000 thyroid panel covers the five core function assays in that grouping. The hormone and fertility panel adds nine assays. Beta-hCG runs in 5 minutes on 50 µL and covers 0.5 to 5000 mIU/mL with a cut-off of <5 mIU/mL. Prolactin covers 1 to 10,000 µIU/mL. Progesterone covers 0.05 to 60 ng/mL. Cortisol covers 0.054 to 63.4 µg/dL. FSH and LH each cover 0.1 to 200 mIU/mL. AMH covers 0.01 to 23 ng/mL. Testosterone covers 0.025 to 15 ng/mL. Estradiol covers 18.4 to 11,010 pmol/L.

Assay format shapes the operational profile of this panel. The thyroid hormones and steroid hormones use competitive detection. TSH, FSH, LH, prolactin, beta-hCG, and AMH use non-competitive detection. Competitive steroid assays run in 5 to 15 minutes and need 100 µL of sample in most cases. The thyroid function assays need only 50 µL. A fertility workup that combines FSH, LH, estradiol, and AMH therefore draws on both formats in one run. The seven independent detection channels let those assays proceed without waiting on each other.

Tumor Markers, Diabetes, and Specialty Panels

Seven tumor marker assays complete the oncology menu. Two tPSA configurations serve different workflow needs. The first covers 0.014 to 100 ng/mL with a cut-off of <4 ng/mL. The second covers 0.018 to 50 ng/mL. CEA covers 0.2 to 1000 ng/mL with cut-offs of 5 ng/mL and 6.5 ng/mL. AFP covers 0.5 to 1000 ng/mL with a cut-off of 7.0 ng/mL. CYFRA21-1 covers 0.1 to 500 ng/mL with a cut-off of 3.3 ng/mL. CA19-9 covers 0.6 to 1000 U/mL with a cut-off of 34 U/mL. CA125 covers 0.6 to 5000 U/mL with a cut-off of 35 U/mL. Every tumor marker assay reports in 5 minutes on 50 µL.

Diabetes testing rests on two assays. HbA1c runs in 5 minutes on 10 µL of whole blood and covers 3.5 to 20%. The assay carries NMPA, CE, and NGSP certification. NGSP alignment matters because it ties results to the DCCT reference method and supports long-term glucose monitoring and risk identification. Insulin runs in 5 minutes on 100 µL and covers 0.2 to 300 µIU/mL.

The remaining specialty panels cover bone metabolism, anemia, allergy, and preeclampsia. The table below summarizes their operational profile.

The 25-OH VD assay covers 3 to 150 ng/mL with a sufficiency cut-off of ≥30 ng/mL. Ferritin covers 0.5 to 2000 ng/mL with sex-specific cut-offs of 30 to 400 ng/mL for males and 13 to 150 ng/mL for females. AB12 covers 5 to 146 pmol/L with a cut-off of >27 pmol/L. IgE covers 0.1 to 2500 IU/mL. sFlt-1 covers 10 to 85,000 pg/mL. PIGF covers 3 to 10,000 pg/mL. The two preeclampsia assays support the sFlt-1/PIGF ratio, a marker pair that helps clinicians assess preeclampsia risk.

Six pipeline assays sit outside the 41 validated tests. Anti-CCP, cTnI, PG I, PG II, HE4, and CA15-3 appear on the menu as coming soon. Laboratories planning a 2026 menu should count only the validated assays toward current testing capacity. The pipeline list signals where the menu will grow next.

The category view explains how one compact analyzer serves so many clinical questions. Inflammation and cardiac testing lean on fast turnaround and whole-blood capability. Thyroid and fertility testing lean on competitive precision at low concentrations. Tumor markers and specialty panels lean on broad measuring ranges and consistent 5-minute reporting. Format, performance, and regulatory status together determine which assays fit a given laboratory.

Performance, Regulatory, and Cost Factors

Sensitivity, Specificity, and Throughput

The C5000 platform achieves a limit of detection of 15 U/mL, which supports its analytical sensitivity specification. For analytical specificity, the platform uses a sandwich CLIA based on specific antigen–antibody interactions. Unbound components are removed through magnetic separation and wash steps, which minimizes background signal and supports high specificity and sensitivity.

Throughput expectations vary widely across the 2026 market:

• Wondfo Accre 120: up to 100 tests per hourin the specification table, and up to 120 tests per hour in the vendor FAQ, with a first result in 10 minutes.
• Benchtop analyzers in small clinics: typically 8–10 samples per hour.
• Floor-standing systems in high-volume hospital laboratories: often exceeding 100–200 tests per hour.

The C5000 reaches a maximum of 80 tests per hour with a 3-minute time to first result. Seven independent detection channels allow time-independent testing, so a stat sample does not wait behind a batch.

NMPA, CE, and NGSP Regulatory Status

NMPA oversight covers immunoassay reagents and analyzers across several device categories.

NMPA published 39 final medical device guidelines on December 1, 2025. These guidelines are not legally binding but are highly recommended. New registrations and five-year renewals must demonstrate conformity, including local type testing even when no product changes occurred. Reviewers assess the complete detection system, not the reagent alone.

NGSP certifies methods and reagents as having documented traceability to the DCCT reference method. Certificates of traceability expire after one year, and the NGSP recommends annual manufacturer recertification.

The C5000 platform holds certification from all three bodies.

Cost and Menu Selection Considerations

Menu selection balances clinical utility against total cost of ownership.  Small laboratories may favor low-to-mid-throughput analyzers for lower running costs, less calibration, fewer reagents, and minimal training. Modular designs and upgrade paths let a laboratory grow throughput without full system replacement. Chemiluminescence dominates for sensitivity, dynamic range, and broad menu adoption.

The C5000 supports three immunoassay formats across 10 clinical panels and 50+ validated assays. Which types of immunoassays can be performed on the C5000? The 2026 menu covers inflammation, cardiac, thyroid, tumor marker, hormone and fertility, diabetes, bone metabolism, anemia, allergy, and preeclampsia testing. Format, performance, and regulatory status together determine which assays fit a given laboratory.

C5000 Test Menu at a Glance

The Poclight C5000 is a compact homogeneous chemiluminescence immunoassay (CLIA) analyzer built on CRET technology. It quantifies biomarkers across multiple clinical areas. The table below summarizes representative assays and the testing needs they support.

Active B12 (AB12) measures the biologically available fraction and differs from Total B12. All results support clinical evaluation alongside other findings. No single marker confirms a diagnosis on its own. The menu lists available assays, not a fixed panel that runs as one combined order.

What the Menu Means for Procurement and Deployment

Small and mid-sized laboratories can match the menu to their common local testing needs and assess which assays to bring in-house. Hospital departments and satellite labs can focus on specific areas such as inflammation, cardiac markers, thyroid, or reproductive hormones, then evaluate turnaround time and workflow fit.

IVD distributors can align instrument and reagent portfolios with local customer types, priority assays, and registration status. Single-use lyophilized reagents, a homogeneous wash-free workflow, a compact footprint, and reagent storage at 2–30°C under specified conditions without cold-chain logistics support on-demand testing, simpler reagent management, and flexible space deployment. Most assays report results in 3–15 minutes, per the corresponding instructions for use. The brand positioning is straightforward: making professional CLIA easier to deploy.

FAQ

Can the Poclight C5000 test Active B12 as well as other markers? Yes. The menu includes Active B12 (AB12) alongside inflammation, cardiac, thyroid, hormone, diabetes, anemia, allergy, and preeclampsia markers. Actual availability depends on the specific assay and local registration status.

Which sample types can be used on the C5000? The platform accepts whole blood, serum, and plasma, but applicability varies by reagent. Laboratories should confirm the validated sample types in each assay's instructions for use rather than assuming whole blood support across all tests.

How can I choose a C5000 test menu for my laboratory or market? Start with the assays your setting orders most often, then confirm local registration and expected turnaround needs. Distributors should map the menu to local customer types and priority projects before finalizing an instrument and reagent combination.

Request a Menu and Configuration Review

Laboratory directors, hospital testing staff, procurement teams, and IVD distributors can contact Poclight with their country, organization type, and assays of interest. The team will share the locally available menu, instrument and reagent configuration options, and pricing. Laboratories can focus on configuration and purchasing; distributors can discuss regional cooperation and product portfolios. Reach the team through the website inquiry form or overseas@poclight.com, and include a work email. WhatsApp is available as an optional contact channel.