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Precision Specimen Solutions Across Healthcare Disciplines

From routine hematology to advanced liquid biopsy, our specimen collection and preservation systems are engineered to meet the exacting demands of modern clinical diagnostics.

Applications Overview

Clinical Laboratory Solutions

Engineering precise vacuum blood collection systems tailored for routine hematology, biochemistry, hemostasis, ESR, metabolic, and emergency diagnostics.

Featured Hematology Solution

1. Complete Blood Count (CBC)

Sample Handling Protocol
🌡️ Storage Temperature: 4°C – 25°C

Important Handling Rule: Avoid freezing samples. For optimal diagnostic results, perform analysis promptly. If sample storage exceeds 24 hours, blood cell morphology and key hematological parameters will undergo alteration.

Application

Designed for routine hematology testing, including complete blood count (CBC), blood cell morphology examination, and flow cytometry.

Key Features

K2/K3 EDTA is uniformly spray-coated on the inner tube wall to ensure rapid, reliable anticoagulation and consistent sample preservation.

⚠️ Testing Limitation: EDTA tubes are not suitable for calcium testing because EDTA chelates calcium ions and will interfere with accurate calcium measurements.

2. Serum Biochemistry

Application

Suitable for a broad range of routine serum biochemistry, immunology, and therapeutic drug monitoring (TDM) applications.

Available Configurations
Plain Tube (No Additive) Clot Activator Tube Gel & Clot Activator (SST)
Key Features & Transport

For specimens requiring long-distance transport or delayed processing, Serum Separator Tubes (SST with gel) provide an effective barrier between serum and blood cells to maintain serum analyte integrity. Follow instruction guidelines after collection.

3. Coagulation Testing

Application

Designed for routine and specialized hemostasis testing, including Prothrombin Time (PT), APTT, D-Dimer, and Fibrinogen assays.

3.2%
Sodium Citrate
9 : 1
Blood-to-Anticoagulant
Sample Handling

Accurate blood fill volume and gentle immediate mixing (5-8 inversions) are strictly required to ensure the correct 9:1 blood-to-anticoagulant ratio for trustworthy results.

Westergren Standard Reference

4. Erythrocyte Sedimentation Rate (ESR)

Designed for ESR testing strictly complying with the ICSH Westergren reference standard. Delivers reliable assessment data for screening acute/chronic inflammation, active infections, and autoimmune disorders.

Traditional Manual Method

Fully compatible with classic manual Westergren glass pipettes and sedimentation rack procedures.

Automated ESR Analyzers

Optimized for modern high-throughput automated analyzers based on modified Westergren measurement principles.

5. Glucose & Lactate Testing

Application & Mechanism

Contains glycolytic inhibitors to stabilize blood glucose and lactate levels, preventing in vitro breakdown of glucose by erythrocytes.

Common Diagnostic Scope
Fasting Blood Glucose Oral Glucose Tolerance (OGTT) Blood Lactate Analysis Selected HbA1c Assays
Compatibility & Usage Note

Compatible with select instrument systems for dual HbA1c testing (verify reagent compatibility prior to use). Not recommended for enzyme activity testing.

6. Plasma Biochemistry & Emergency Testing

Application

Heparin tubes provide anticoagulated plasma specimens for rapid plasma chemistry panels and emergency laboratory testing.

Common Applications
STAT Emergency Chemistry Plasma Biochemistry Panels Electrolyte Profiles Blood Ammonia Testing Critical Care Plasma Assays
Key Features

The heparin formulation maintains a stable plasma sample environment, allowing immediate centrifugation without waiting for blood clotting, supporting fast STAT turn-around times.

Recommended Product

Clinical Laboratory Product Matrix

Comprehensive selection guide for routine blood collection tubes across biochemistry, hematology, coagulation, ESR, and emergency diagnostics.

Clinical Laboratory Collection Product Matrix

Product Additive Cap Color Features & Applications
Plain Tube
(No Additive tube)
No Additive Red No Additive. Used for determinations in biochemistry, immunology and serology.
Minimum recommended clotting time: 60 minutes.
Serum Tube
(Clot Activator tube)
Clot Activator Red Used for preparing premium serum for determinations in biochemistry, immunology, trace element, serology and various types of virus detection.
Minimum recommended clotting time: 30 minutes.
SST Tube
(Gel and clot activator tube)
Gel & Clot Activator Yellow Additive: Clot Activator | Accessory: Separating gel.
Used for preparing premium serum for determinations in biochemistry, immunology, trace element, virus detection and serology.
EDTA Tube
(K2/K3 EDTA tube)
K2 / K3 EDTA Purple K2EDTA or K3EDTA.
Used for tests including hematology, PCR diagnostics and blood group research, widely used in clinical hematology.
ESR Tube
(4NC sodium citrate tube)
3.8% Sodium Citrate Black Additive: 3.8% Sodium Citrate.
Used for Westergren sedimentation rate determination. Blood and sodium citrate volume ratio is 4:1.
PT Tube
(9NC sodium citrate tube)
3.2% / 3.8% Sodium Citrate Blue Used for tests including PT, APTT, Fg, TT, AT, FDP D-Dimer. Blood and sodium citrate volume ratio is 9:1.
Notice: PT tube is not recommended as the first tube to take blood.
Heparin Tube
(Sodium / Lithium heparin tube)
Sodium / Lithium Heparin Green Additive: Sodium Heparin / Lithium Heparin.
Application: Hemorheology or emergency biochemistry diagnostics.
Glucose Tube
(Sodium Fluoride tube)
Sodium Fluoride + EDTA Gray Additive: Sodium Fluoride with K2EDTA / Potassium Oxalate.
Used for glucose determination. Compared with potassium oxalate, EDTA provides better sample quality with results in less than 24 hours.
Non-Invasive Prenatal Testing

cfDNA Preservation for Fetal Screening

Xinle cfDNA BCT stabilizes circulating cell-free DNA in maternal blood, enabling accurate non-invasive screening of fetal chromosomal and genetic conditions via high-throughput sequencing.

Featured cfDNA Preservation Solution

Xinle cfDNA BCT

cfDNA Preservation

Xinle cfDNA BCT effectively inhibits nuclease activity to prevent the degradation of cell-free DNA (cfDNA). At the same time, it stabilizes blood cells and prevents genomic DNA contamination caused by cellular lysis, ensuring the integrity and accuracy of plasma cfDNA during long-term room temperature transportation.

High-Throughput Sequencing Ready

It provides stable preservation of circulating cell-free DNA and meets the requirements of high-throughput sequencing applications.

Testing Applications

Six NIPT Screening Applications

Comprehensive cfDNA-based screening coverage from common trisomies to fetal RhD genotyping and paternity analysis.

Trisomy 21/18/13 Screening

Xinle cfDNA BCT ensures accurate NGS-based detection of chromosomal aneuploidies involving chromosomes 21, 18, and 13.

Sex Chromosome Aneuploidy Detection

Xinle cfDNA BCT enables reliable detection of sex chromosome abnormalities, including Turner syndrome (45,X), Triple X syndrome (47,XXX), Klinefelter syndrome (47,XXY), and Jacobs syndrome (47,XYY).

Microdeletion Syndrome Detection

Xinle cfDNA BCT ensures accurate detection of microdeletion syndromes, including DiGeorge syndrome (22q11.2 deletion), Prader–Willi syndrome (15q11.2-q13 deletion), and Cri-du-chat syndrome (5p15.3 deletion).

Fetal RhD Genotyping

Xinle cfDNA BCT supports accurate fetal RhD blood group identification, providing reliable guidance for Rh immunoglobulin (RhIg) prophylactic treatment.

Non-Invasive Prenatal Paternity Testing

Xinle cfDNA BCT is suitable for non-invasive prenatal paternity testing based on STR analysis directly from maternal peripheral blood samples.

Potential Maternal Malignancy Identification

Xinle cfDNA BCT supports the incidental detection of potential maternal malignancies during routine NIPT screening.

Recommended Product

NIPT Product Selection Guide

Purpose-built cfDNA collection tubes for non-invasive prenatal testing and downstream NGS library preparation.

NIPT Collection Product Matrix

PRODUCT Type Specification Primary Application
cfDNA BCT Blood Collection 5 mL / 8 mL / 9 mL / 10 mL NIPT & NGS Library Preparation
Product Performance

cfDNA BCT Performance Benchmarks

Key stability and performance indicators validated by independent clinical laboratory studies.

7 Days
cfDNA Stability at 10–30°C
<0.1%
Maternal Cellular Lysis Rate
≥10%
Fetal Fraction
99.8%
NIPT Testing Success Rate
Sample Collection Workflow

From Blood Draw to NGS Library

An optimized NIPT sample processing workflow with four key steps ensures high-quality cfDNA preservation for downstream NGS library preparation and accurate bioinformatic analysis.

1

Venous Blood Collection

Collect peripheral blood into the Xinle cfDNA BCT using a 21G–23G blood collection needle.

2

Gentle Mixing & Room Temperature Transportation

After blood collection, gently invert the tube 5–8 times. The tube can preserve samples for up to 7 days at 10–30°C without requiring cold-chain transportation.

3

Plasma Separation by Centrifugation

Centrifuge at 1500–2300 × g for 10 minutes to separate plasma.

4

cfDNA Extraction & NGS Library Preparation

Compatible with next-generation sequencing platforms including Illumina VeriSeq, Ion Torrent, and BGI. The tube is fully compatible with automated laboratory workflows.

Tumor Screening & Liquid Biopsy

Preservation Solutions for Tumor Screening

Xinle cfDNA BCT, cfRNA BCT, and Urine DNA Preservation Tubes effectively inhibit nuclease activity, prevent background nucleic acid release caused by blood cell lysis, and maintain circulating tumor DNA/RNA stability during room-temperature transport for reliable tumor genetic mutation detection.

Blood-Based Liquid Biopsy Preservation

1. cfDNA / cfRNA Preservation for Tumor Screening

Xinle cfDNA BCT and cfRNA BCT effectively inhibit nuclease activity, prevent the release of background nucleic acids caused by blood cell lysis, and maintain the stability of circulating tumor DNA/RNA during long-term room temperature transportation, ensuring reliable detection of tumor genetic mutations.

Blood Detection Applications

Four Core Blood-Based Liquid Biopsy Applications

Comprehensive stabilization covering ctDNA mutation analysis, ctRNA/miRNA profiling, MRD tracking, and intact CTC preservation.

I. Circulating Tumor DNA (ctDNA) Detection

ctDNA is released into the bloodstream through apoptosis or necrosis of solid tumor cells and carries tumor-specific genetic mutation information. It is one of the key targets in liquid biopsy applications.

Stabilization Mechanism

Specially designed stabilizing reagent system inhibits plasma nuclease activity while preventing white blood cell lysis and non-target gDNA release, maintaining ctDNA stability at room temp for up to 7 days.

Main Application

Preservation and transportation of cell-free DNA from blood samples for tumor screening and molecular analysis.

II. Circulating Tumor RNA (ctRNA / miRNA) Detection

The expression profiles of microRNA (miRNA) and mRNA undergo significant changes during tumor development and progression, making them promising biomarkers for early cancer screening and tumor classification.

Stabilization Mechanism

cfRNA Blood Collection Tubes inhibit plasma RNase activity, stabilize circulating cell-free RNA, and prevent the release of background RNA and RNase caused by blood cell lysis.

Main Application

Collection, preservation, and transportation of circulating RNA from blood samples for tumor screening.

III. Minimal Residual Disease (MRD) Monitoring

Ultra-sensitive ctDNA detection is widely used for postoperative recurrence risk assessment and treatment strategy optimization.

Key Feature

cfDNA Blood Collection Tubes provide stable preservation of low-abundance ctDNA, supporting accurate MRD detection and longitudinal monitoring.

IV. Circulating Tumor Cell (CTC) Detection

Xinle cfDNA BCT and cfRNA BCT help maintain cell membrane integrity and prevent rare circulating tumor cells from breaking down after blood collection.

Key Feature

By preserving tumor cell surface-specific antigens, these tubes provide reliable support for downstream circulating tumor cell isolation and detection.

Non-Invasive Urinary Tumor Screening

2. Consumables for Non-Invasive Urinary System Tumor Screening

Tumor DNA from epithelial tumors of the urinary system, including bladder cancer, kidney cancer, and prostate cancer, can be released into urine. Urine DNA Preservation Tubes inhibit nuclease activity in urine samples and prevent the release of genomic DNA from nucleated exfoliated cells.

Main Application & Diagnostic Scope

Main Application: Preservation and transportation of urine DNA samples for early diagnosis and molecular testing of urinary system diseases.

Ⅰ. Gene Mutation Detection: TERT promoter mutations (C228T / C250T), KRAS, HRAS, PIK3CA, TP53 Ⅱ. DNA Methylation Detection: ONECUT2, VIM
Recommended Products

Tumor Screening Product Matrix

Specially formulated blood and urine collection consumables for liquid biopsy, ctDNA/cfRNA preservation, and urinary tumor diagnostics.

Tumor Screening Product Matrix

Product Name Additive / Preservative Primary Applications
cfDNA BCT (5mL / 10mL) K2EDTA + Proprietary Stabilizer ctDNA Mutation Detection & MRD Monitoring
cfRNA BCT cfRNA Preservation Solution ctRNA / miRNA Detection
Urine DNA Preservation Tube DNA Stabilizer Non-Invasive Urinary System Tumor Screening
Performance Metrics

Product Performance Highlights

7 Days
Stable ctDNA Room Temp Preservation
7 Days
Stable cfRNA Room Temp Preservation
<0.1%
Blood Cell Lysis Rate
100%
Efficient RNase Inhibition
≥7 Days
Urine Sample Room Temp Preservation
Standardized Protocols

Sample Collection Workflow

Step-by-step procedures for blood and urine specimen collection, stabilization, transportation, and molecular analysis.

Blood Samples (ctDNA / ctRNA / Whole Blood DNA Testing)

1

Blood Collection

Collect peripheral blood using a 21G–23G needle into cfDNA/cfRNA/whole blood DNA collection tubes.

2

Gentle Inversion

Immediately invert the tube gently 5–8 times to ensure complete mixing with the stabilizer.

3

Room Temp Transport

Transport at room temperature (6–37°C) without requiring cold-chain transportation.

4

Plasma Separation

Centrifuge to separate plasma at 1,500–2,300 × g for 10 minutes.

5

Molecular Analysis

Proceed directly with cfDNA/cfRNA extraction and downstream NGS or PCR analysis.

Urine Samples (Urinary System Tumor Detection)

1

Urine Collection

Collect 30–80 mL of midstream urine into a sterile urine container.

2

Sample Transfer

Transfer the urine sample into the Urine DNA Preservation Tube.

3

Gentle Inversion

Immediately invert the tube gently 5–10 times for proper mixing.

4

Room Temp Transport

Transport at room temperature without cold-chain requirements.

5

Downstream Testing

Perform urine cfDNA extraction and downstream molecular testing.

Blood Banking & Transfusion Medicine

Blood-Related Testing for Blood Banking & Transfusion Medicine

Engineering advanced vacuum blood collection systems designed for transfusion safety, whole-blood cell preservation, HLA tissue typing, CDC crossmatching, and high-sensitivity nucleic acid testing (NAT) for transfusion-transmitted infections.

Featured Transfusion Diagnostic Solutions

Xinle ACD & PPT Specimen Collection Systems

(I) Xinle ACD Blood Preservation Tube

Xinle's ACD blood preservation tube effectively prevents coagulation, maintains blood cell viability and antigen integrity, and supports stable preservation of whole-blood specimens at 2–8 °C for up to 21 days.

(II) Xinle PPT Tube (Plasma Preparation Tube for Nucleic Acid Testing)

Xinle's PPT tube effectively prevents coagulation and facilitates plasma separation. The product is sterile, pyrogen-free, DNase-free, and RNase-free, and does not interfere with nucleic acid amplification, providing transfusion-related molecular diagnostics with high-quality qualified specimens.

Testing Applications

Transfusion Diagnostic & Screening Applications

Targeted testing protocols for donor-recipient histocompatibility, crossmatching, and viral safety screening.

1. HLA Genotyping (Tissue Typing)

Used to extract genomic DNA from patients or donors and identify HLA-A, -B, -C, -DR, and -DQ loci by molecular diagnostic methods.

2. CDC Crossmatch

Complement-Dependent Cytotoxicity Crossmatch (CDC Crossmatch). ACD tubes preserve cell viability and have minimal effect on complement activity, making them well suited to sample collection for CDC crossmatching.

3. Transfusion-Transmitted Infection NAT

Testing for transfusion-transmitted infections primarily includes HBV, HCV, HIV, and Treponema pallidum (syphilis). Nucleic acid testing (NAT) offers high sensitivity and accurate results.

Recommended Products

Blood Banking & Transfusion Product Matrix

Specialized collection tubes formulated for long-term whole-blood storage, cell stability, and molecular NAT assays.

Blood Banking Collection Product Matrix

PRODUCT Additive Cap Color Primary Application
ACD Blood Preservation Tube Acid Citrate Dextrose Yellow Top HLA Genotyping and CDC Crossmatching
PPT Tube (Nucleic Acid Testing Tube) K2EDTA + Separation Gel White / Pearl Top Nucleic Acid Testing for Transfusion Infections
Product Performance

Blood Banking Performance Benchmarks

Validated performance specifications ensuring specimen integrity and analytical accuracy.

21 Days
Whole-Blood Stability at 2–8°C (ACD Tubes)
DNase/RNase
Free & Pyrogen-Free Certification (PPT Tubes)
-80°C
In-Tube Deep Freeze Storage (PPT Tubes)
3,000g
Maximum Centrifugal Force (PPT & ACD Tubes)
Collection Procedure

Step-by-Step Sample Collection Workflow

Standardized operational protocol for blood sample collection, mixing, temperature-controlled transport, and downstream handling.

1

Whole Blood Collection

Collect whole blood into the collection tube using the matching blood collection needle.

2

Immediate Gentle Inversion

Immediately and gently invert the tube 5–8 times after collection to mix thoroughly.

3

Blood Bank Transport

Transport to the blood bank at 2–8 °C or room temperature.

4

Processing & Testing

Centrifuge to separate plasma or use whole blood directly for testing.

Immunology & Genetic Testing Solutions

PBMC Isolation & Immunogenomics Diagnostics

Xinle's Cell Preparation Tube (CPT) combines anticoagulant with density gradient media and gel barrier for one-step isolation of viable mononuclear cells (PBMCs), advancing immunogenetics, flow cytometry, minimal residual disease (MRD), and molecular diagnostics.

Featured Mononuclear Cell Isolation Solution

Xinle Cell Preparation Tube (CPT)

(I) One-Step PBMC Preparation Technology

Xinle's Cell Preparation Tube (CPT) is used to collect venous blood specimens and prepare mononuclear cell suspensions. It enables one-step centrifugation to isolate peripheral blood mononuclear cells (PBMCs) while maintaining high cell viability. The isolated mononuclear cells are suitable for molecular diagnostics platforms, flow cytometry platforms, and cell culture.

(II) Integrated Density Gradient & Gel Barrier

By integrating polyester gel separation barrier with density gradient media in a single closed blood collection system, CPT eliminates manual layer blood piping, reduces contamination risk, and standardizes pre-analytical cell harvesting for clinical laboratories.

Testing Applications

Six Primary Immunological & Genetic Diagnostic Applications

Targeted workflows supporting immune cell functional assays, leukemia marker screening, HLA tissue typing, and precision pharmacogenomics.

1. Lymphocyte Immune Function Testing

Flow cytometry for lymphocyte subset analysis (CD3+, CD4+, CD8+, B cells, NK cells) and absolute enumeration in clinical immune function assessment.

2. Leukemia Marker & MRD Testing

High-sensitivity molecular detection of leukemia-associated genetic markers for Minimal Residual Disease (MRD) monitoring post-chemotherapy.

3. HLA Genotyping (Tissue Typing)

Human Leukocyte Antigen (HLA) genotyping extracting high-purity genomic DNA for allele typing across HLA-A, -B, -C, -DR, and -DQ loci.

4. Immune Repertoire Sequencing

Deep sequencing of T-cell receptor (TCR) and B-cell receptor (BCR) immune repertoires to evaluate immune dynamics and disease progression.

5. Cell Culture & Functional Assays

Preserves high mononuclear cell viability for ex vivo cell culture, ELISPOT, cytokine release assays, and functional cellular immunity monitoring.

6. Pharmacogenomics Testing

Targeted genotyping of key drug-hypersensitivity genetic markers (e.g., HLA-B*5701, HLA-B*1502) to guide individualized precision therapy.

Recommended Products

Immunology & Genetic Testing Product Matrix

Specialized cell preparation and molecular collection tubes for immunogenomics laboratories.

Immunology Collection Product Matrix

PRODUCT Additive Cap Color Primary Application
Cell Preparation Tube (CPT - Heparin) Sodium Heparin + Density Gradient + Gel Green Top PBMC Isolation, Flow Cytometry & Cell Culture
Cell Preparation Tube (CPT - Citrate) Sodium Citrate + Density Gradient + Gel Blue Top Molecular Diagnostics, HLA Typing & TCR/BCR Sequencing
EDTA K2/K3 Tube (Nuclease-Free) Spray-Dried EDTA Lavender Top MRD Leukemia Markers & Genomic DNA Extraction
Xinle cfRNA BCT RNA Stabilization Solution Red Top Gene Expression & Transcriptomics
Product Performance

CPT Mononuclear Cell Isolation Metrics

Validated performance benchmarks for immunogenetics reference laboratories and clinical trial sites.

>90%
PBMC Cell Viability Post-Isolation
1-Step
Centrifugation Separation Protocol
15–20 Min
Centrifugation at 1500–1800g
DNase/RNase
Free & Sterile Tube Inner Wall
Collection & Handling Protocol

CPT PBMC Isolation Workflow

Standardized operational protocol ensuring optimum mononuclear cell yield and viability.

1

Venous Blood Collection

Draw venous blood into CPT tube up to the recommended fill line using standard venipuncture techniques.

2

Immediate Gentle Inversion

Gently invert the tube 8–10 times immediately after collection to mix blood thoroughly with anticoagulant.

3

One-Step Centrifugation

Centrifuge at 1500–1800g for 15–20 minutes at room temperature within 2 hours of specimen collection.

4

PBMC Harvesting & Testing

Aspirate the distinct mononuclear cell layer above the gel for flow cytometry, molecular diagnostic assays, or cell culture.

Invasive Fungal Infection Testing

Pyrogen-Free Blood Collection Tubes for G Test / GM Test

Xinle's pyrogen-free blood collection tubes are engineered with strict control of product endotoxin levels. Serum tubes are optimized for collecting specimens for G tests and GM tests, preventing false-positive interference and supporting combined multi-marker fungal pathogen diagnostics.

Featured Pyrogen-Free Specimen Solution

Xinle Pyrogen-Free Blood Collection Systems

(I) Strict Endotoxin Level Control

Xinle's pyrogen-free blood collection tubes are manufactured with stringent endotoxin control (<0.005 EU/mL). By preventing exogenous bacterial endotoxin contamination, these tubes protect the Factor G enzymatic activation pathway in Limulus amebocyte lysate (LAL) reagents, avoiding false-positive interference during clinical fungal screening.

(II) Multi-Configuration Serum Preparation

Because clinical fungal infections are complex, multiple testing methods are usually used in combination to investigate pathogens one by one. Xinle provides multiple pyrogen-free configurations (Plain, Clot Activator, Separating Gel + Clot Activator) enabling single-tube high-yield serum harvesting for combined G-test and GM-test diagnostic panels.

Testing Applications

Core Diagnostic Applications for Invasive Fungal Infection

Dual biomarker testing protocols for early screening and precise identification of deep fungal pathogens.

1. G Test — (1→3)-β-D-Glucan Testing

(1→3)-β-D-glucan is a key fungal cell wall component released into blood during infection. Using Xinle pyrogen-free tubes prevents bacterial endotoxin from accidentally activating the Factor C pathway in Limulus lysate (LAL) reagents, eliminating false positives and ensuring true Factor G pathway sensitivity for fungal detection.

2. Combined G Test & GM Test

The Galactomannan antigen test (GM test) detects early Aspergillus infection. Combining GM testing with G testing significantly improves invasive fungal diagnostic performance. High-quality serum from a single Xinle pyrogen-free tube supports multiple tests, providing strong guidance for clinical antifungal therapy.

Recommended Products

Pyrogen-Free Product Matrix

Certified pyrogen-free collection tubes designed for high-sensitivity G test / GM test serum preparation.

Pyrogen-Free Collection Product Matrix

PRODUCT Specification Cap Color Main Application
Pyrogen-free blood collection tube (clot activator) 3, 4, 5 mL Red Top Serum samples for G test / GM test
Pyrogen-free blood collection tube (separating gel + clot activator) 3.5, 4, 5 mL Yellow Top Serum separation and direct instrument testing
Pyrogen-free blood collection tube (plain tube) 3, 4, 5 mL Red / Clear Top Routine serum sample collection
Product Performance

Pyrogen-Free Quality & Endotoxin Control Standards

Strictly validated performance metrics for clinical fungal diagnostics and critical care units.

<0.005 EU/mL
Extremely Low Endotoxin Content
Pyrogen-Free
Sterile & Non-Interfering Inner Wall
Multi-Config
Clot Activator, Gel, Plain & Heparin
Customized
Tailored Manufacturing Available
Collection Protocol

Standard Blood Collection Procedure for G Test / GM Test

Standardized operational protocol to guarantee pyrogen-free serum quality from venipuncture to testing.

1

Venous Blood Draw

Use a pyrogen-free blood collection tube to collect peripheral venous blood.

2

Indicated Fill Volume

Collect the blood strictly according to the indicated collection volume line.

3

Immediate Gentle Inversion

Immediately and gently invert the tube 5–8 times after collection.

4

Room Temp Clotting

Allow sample to stand at room temp for 30–60 mins until fully clotted.

5

Serum Centrifugation

Centrifuge at recommended speed to separate clean serum.

6

G / GM Testing

Perform testing immediately or store the sample as required.

Bacterial Endotoxin Testing

Pyrogen-Free Specimen Collection for LAL Factor C Assay

Bacterial endotoxin is the most critical pyrogen in clinical diagnostics. Xinle's pyrogen-free blood collection tubes maintain extremely low endotoxin levels, protecting the Limulus amebocyte lysate (LAL) Factor C enzymatic activation pathway from sample contamination and false-positive interference.

Featured Endotoxin-Free Specimen Solution

Xinle Pyrogen-Free Blood Collection System for BET

(I) Specific Protection for LAL Factor C Pathway

Detecting bacterial endotoxin in blood specimens is an important means of assessing infection. The Limulus amebocyte lysate (LAL) method relies on the Factor C enzymatic pathway, specifically activated by bacterial endotoxin. Xinle's pyrogen-free collection tubes eliminate exogenous endotoxin contamination at the source, preventing false-positive results.

(II) Versatile Serum & Plasma Formulations

Medical devices with endotoxin levels below specified limits qualify as pyrogen-free. Xinle offers Clot Activator, Sodium Heparin, Gel + Clot Activator, and Plain Tube configurations, providing certified pyrogen-free collection for serum and plasma endotoxin assays and pyrogen-sensitive research.

Testing Applications

Core Diagnostic & Research Applications for Bacterial Endotoxin

Targeted specimen collection for endotoxemia screening, Gram-negative sepsis workup, and pyrogen-sensitive immunological studies.

1. Bacterial Endotoxin Testing (BET)

Quantitative clinical testing for Gram-negative bacterial infection and systemic endotoxemia, utilizing pyrogen-free collection tubes to prevent sample contamination from causing false-positive LAL reactions.

2. Auxiliary Sepsis Diagnosis

Rapid diagnostic aid for patients clinically suspected of Gram-negative bacterial sepsis, bacteremia, or severe acute endotoxemia in ICU and critical care settings.

3. Pyrogen-Sensitive Research

In clinical research assessing febrile reactions, cytokine release profiles, and immune activation pathways, pyrogen-free tubes eliminate exogenous pyrogen noise right from the sample collection source.

Recommended Products

Pyrogen-Free Product Matrix for Endotoxin Testing

Certified pyrogen-free collection tubes designed for high-sensitivity LAL Factor C endotoxin assays.

Endotoxin Collection Product Matrix

PRODUCT Specification Cap Color Main Application
Pyrogen-free blood collection tube (clot activator) 3, 4, 5 mL Red Top Serum samples for endotoxin testing
Pyrogen-free blood collection tube (sodium heparin) 3, 4, 5 mL Green Top Plasma samples for endotoxin testing
Pyrogen-free blood collection tube (separating gel + clot activator) 3.5, 4, 5 mL Yellow Top Testing after serum separation
Pyrogen-free blood collection tube (plain tube) 3, 4, 5 mL Red / Clear Top Routine endotoxin testing
Product Performance

Pyrogen-Free Standards & Quality Metrics

Strict quality controls meeting BET regulatory limits for clinical diagnostics and pyrogen-sensitive studies.

Sterile
& Pyrogen-Free Certified Inner Wall
<0.005 EU/mL
Extremely Low Endotoxin Content
Factor C
Protected LAL Enzymatic Pathway
Customized
Tailored Manufacturing Available
Collection Protocol

Standard Blood Collection Procedure for BET Testing

Standardized operational protocol to guarantee pyrogen-free specimen quality from venipuncture to testing.

1

Venous Blood Draw

Use a pyrogen-free blood collection tube to collect peripheral venous blood.

2

Indicated Fill Volume

Collect the blood strictly according to the indicated collection volume line.

3

Immediate Gentle Inversion

Immediately and gently invert the tube 5–8 times after collection.

4

Controlled Standing

Allow sample to stand at room temperature per specific testing method requirements.

5

Centrifugation Separation

Centrifuge at recommended speed to separate clean serum or plasma.

6

Bacterial Endotoxin Testing

Perform BET testing immediately or store the sample as required by assay IFU.

IGRA Diagnostic Solutions

Tuberculosis Testing

Xinle provides specialized blood collection solutions for tuberculosis IGRA testing. CPT tubes enable one-step PBMC isolation, while pyrogen-free sodium-heparin tubes ensure whole-blood stimulation without endotoxin interference for stable and reliable results.

Diagnostic Principle & Background

Interferon-Gamma Release Assay (IGRA) Mechanism

Individuals infected with Mycobacterium tuberculosis (MTB) have memory lymphocytes that specifically recognize tuberculosis-specific antigens. When exposed again to tuberculosis-specific antigens in vitro, these cells produce large amounts of interferon-gamma (IFN-γ). Measuring IFN-γ indicates whether MTB infection is present.

Heparin-anticoagulated blood is typically used with a negative control tube (N tube), positive control tube (P tube), and specific stimulation antigen tube (T tube). Whole-blood specimens are incubated to stimulate peripheral blood T-cell responses before plasma centrifugation and IFN-γ measurement.

Critical Endotoxin Impact on Baseline Results: The negative control (N tube) reflects baseline γ-interferon concentration or background cellular immune response. Studies confirm that endotoxin directly affects IFN-γ production; pyrogen contamination in blood collection tubes can cause N-tube values to exceed assay cutoffs, invalidating test interpretation.
Scope of Application

Testing Items

Core diagnostic testing applications and immunological assessments for tuberculosis screening.

TB Infection Testing (IGRA)

Interferon-gamma release assay (IGRA) for detecting Mycobacterium tuberculosis infection in clinical and health screening populations.

T-Cell Immune Response

Assessment of tuberculosis-specific T-cell cellular immune responses for accurate differentiation of infection status.

Selection & Performance

Recommended Products & Performance

High-purity collection consumables specifically designed for IGRA whole-blood and PBMC isolation assays.

Tuberculosis IGRA Product Matrix

PRODUCT Additives Cap Color Primary Application
CPT Tube (Cell Preparation Tube) Density-gradient medium + anticoagulant Red / Blue PBMC Isolation for IGRA Assays
Pyrogen-Free Sodium-Heparin Tube Sodium Heparin Green Whole-Blood Stimulation IGRA Testing
1-Step Centrifuge
Precise separation & simple PBMC recovery (CPT tube)
Pyrogen-Free
Prevents non-specific IFN-γ baseline interference
Sterile
Ensures specimen integrity during incubation
Universal
Compatible with mainstream commercial IGRA kits
Standard Operating Procedures

Sample Collection Procedure

Standardized operational workflows for CPT tube PBMC isolation and Pyrogen-Free Sodium-Heparin whole-blood IGRA testing.

Method 01

IGRA Testing (CPT Tube)

One-step centrifugation method for mononuclear cell (PBMC) isolation
6-Step Protocol
1

Blood Draw

Collect whole blood into the CPT tube (sodium-heparin anticoagulated type).

2

Inversion

Immediately and gently invert 8–10 times.

3

Stand Vertically

Allow the tube to stand vertically at room temperature.

4

Centrifugation

Centrifuge — isolate PBMCs using the one-step centrifugation method.

5

PBMC Harvest

Collect the PBMC layer.

6

Assay Protocol

Proceed according to the reagent kit instructions.

Method 02

IGRA Testing (Pyrogen-Free Heparin Blood Collection Tube)

Whole-blood stimulation assay compatible with mainstream commercial reagent kits
5-Step Protocol
1

Venous Draw

Use a pyrogen-free heparin blood collection tube to collect peripheral venous blood.

2

Exact Volume

Collect the blood strictly according to the indicated collection volume.

3

Gentle Inversion

Immediately and gently invert 5–8 times after collection.

4

Room Temp Stand

Allow the sample to stand at room temperature for 30–60 minutes.

5

Reagent Incubation

Proceed according to the testing reagent instructions.

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