Cytomegalovirus Detection Kit (Fluorescence PCR)
This Cytomegalovirus (CMV) Detection Kit (Fluorescence PCR) is an in vitro real-time PCR test for the quantitative detection of cytomegalovirus (CMV) nucleic acid in human urine, blood or plasma.
Specifications
- Analytical Sensitivity (LoD): 500 copies/mL
- Storage: -20℃±5℃
- Shelf Life: 12 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0203EY | Cytomegalovirus Detection Kit (Fluorescence PCR) | Human urine, blood or plasma | 48/96 Tests/Kit | CE Marked |
Dengue Virus Detection Kit (Fluorescence PCR)
The Dengue Virus Detection Kit (Fluorescence PCR) is a qualitative in vitro real-time RT-PCR test for the detection of Dengue Virus (DEN) RNA in human serum and plasma from individuals suspected of Dengue Virus infectious.
Specifications:
- Analytical Sensitivity (LoD): 1×10⁴copies/mL
Storage
- 101A0211EY: -20℃±5℃
- 101A0211ED(Lyophilization): 0℃-35℃
Shelf Life
- 101A0211EY: 12 months
- 101A0211ED(Lyophilization): 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0211EY | Dengue Virus Detection Kit (Fluorescence PCR) | Human serum and plasma | 48/96 Tests/Kit | CE Marked |
| 101A0211ED | 48/96 Tests/Kit (Lyophilization) |
Ebola Virus
Ebola virus causes a severe and often fatal illness in humans known as Ebola virus disease (EVD), formerly known as Ebola hemorrhagic fever. Prominent examples of ebolaviruses that cause human disease include Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus. These viruses are responsible for outbreaks primarily in sub-Saharan Africa. The average Ebola disease case fatality rate is around 50%. Case fatality rates have varied from 25–90% in past outbreaks. For EVD, the incubation period ranges from 2 to 21 days. The onset is usually sudden and is characterized by nonspecific signs such as intense weakness, myalgia, headache, and sore throat. This is followed by vomiting, diarrhea, rash, and symptoms of impaired kidney and liver function. In some cases, both internal and external bleeding may occur (e.g., oozing from the gums or blood in stools). Severe gastrointestinal and neurological signs may also occur in the later phases of the disease.
Test Benefits:
- Easy-to-operate design
- Stable at room temperature
- Accurate and reliable results
Ordering Information
| Specimen | Specimen Type | Kit Size | Format | Storage |
|---|---|---|---|---|
| Ebola Virus Fluorescence PCR Kit (Lyophilized) | Whole blood, serum, plasma, saliva, oral swabs, urine | 48 Tests/Kit | Lyophilized | 2℃ to 30℃ |
| Ebola Virus Detection Kit (Fluorescence PCR) | Whole blood, serum, plasma, saliva, oral swabs, urine | 48 Tests/Kit | Liquid | -25℃ to -15℃ |
Test Procedure
Frequently Asked Questions (FAQ)
1: Can standard Ebola PCR tests detect the active Bundibugyo variant?
Not all of them. Many early-generation or highly specific single-target PCR tests were engineered exclusively to detect the Zaire ebolavirus lineage, as it was historically the most prevalent. To address modern multi-variant outbreaks like the current crisis in the DRC and Uganda, laboratories must deploy multiplex or broad-spectrum fluorescence PCR assays specifically designed to detect multiple lineages (Zaire, Sudan, Bundibugyo, and Reston) simultaneously.
2: What sample types are validated for modern molecular Ebola testing?
While serum, plasma, and whole blood remain standard for definitive clinical laboratory testing, advanced molecular diagnostics have expanded sample matrix validations. High-performance PCR kits can accurately process non-invasive or easily accessible field specimens, including saliva, oral swabs, and urine, reducing risks associated with phlebotomy in remote areas.
3: How do lyophilized molecular kits improve field outbreak response?
Standard liquid PCR reagents require deep-freeze storage temperatures (between $-25^{\circ}C$ and $-15^{\circ}C$). Maintaining this strict cold chain is incredibly difficult in remote regions. Lyophilized (freeze-dried) molecular diagnostic kits are stable at room temperature (2°C to 30°C), meaning they can be transported, stored, and deployed instantly at remote border checkpoints and field clinics without specialized refrigeration infrastructure.
4: How do multiplex PCR assays prevent false positives from look-alike tropical diseases?
Diseases like Marburg, Lassa fever, Dengue, Yellow fever, and Chikungunya often present with identical early symptoms to Ebola. Advanced fluorescence PCR assays undergo extensive analytical cross-reactivity validation to guarantee zero cross-reactivity with these co-circulating pathogens, ensuring a positive result explicitly confirms the presence of Ebola virus RNA.
5: What role does an Internal Amplification Control (IC) play in Ebola diagnostics?
An internal control is a secondary genetic target added to the assay mixture and tracked on its own distinct fluorescence channel (such as VIC/HEX). It runs concurrently with the target virus channel (FAM). If the internal control fails to amplify, the laboratory is immediately alerted to potential sample degradation, improper extraction, or PCR inhibition, safely preventing false-negative reporting.
Epstein-Barr Virus Detection Kit (Fluorescence PCR)
The Epstein-Barr Virus Detection Kit (Fluorescence PCR) is a quantitative in vitro real-time PCR test for the detection of Epstein-Barr virus (EBV) DNA in human blood, serum and plasma from individuals suspected of EBV infectious.
Specifications
- Analytical Sensitivity (LoD): 500 copies/mL
- Storage: -20℃±5℃
- Shelf Life: 12 months
Ordering Information
| Product Description | Specimen | Catalog No. | Kit Size | Registration |
|---|---|---|---|---|
| Epstein-Barr Virus Detection Kit (Fluorescence PCR) | Whole blood, serum or plasma | 101A0204EY | 48 Tests/Kit | CE Marked |
Neisseria Gonorrhoeae Detection Kit (Fluorescence PCR)
The Neisseria Gonorrhoeae Detection Kit (Fluorescence PCR) is an in vitro real-time PCR test for the presumptive qualitative detection of nucleic acid from the Neisseria Gonorrhoeae (NG) DNA in Male urethral swab and female cervical secretions samples from individuals suspected of infection.
Specification
- Analytical Sensitivity (LoD): 1000 copies/mL
Storage
- 101A0216EY: -20℃±5℃
- 101A0216ED (Lyophilization): 0℃-35℃
Shelf Life
- 101A0217EY：12 months
- 101A0217ED (Lyophilization): 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0217EY | Neisseria Gonorrhoeae Detection Kit (Fluorescence PCR) | Male urethral swab and female cervical secretions | 48/96 Tests/Kit | CE Marked |
| 101A0217ED | 48/96 Tests/Kit (Lyophilization) |
Group A Streptococcus Detection Kit (Fluorescence PCR)
The Group A Streptococcus Detection Kit (Fluorescence PCR) is a qualitative in vitro real-time PCR test for the detection of nucleic acid from group A streptococcus (GAS)DNA in oropharyngeal swab specimens from individuals suspected of GAS infectious.
Specifications
- Analytical Sensitivity (LoD): 1000 copies/mL
- Storage: -20℃±5℃
- Shelf Life: 101A0202EY: 12 months
Ordering Information
| Product Description | Specimen | Catalog No. | Kit Size | Registration |
|---|---|---|---|---|
| Group A Streptococcus Detection Kit (Fluorescence PCR) | Oropharyngeal swab | 101A0202EY | 48 Tests/Kit | CE Marked |
Hantavirus
Hantavirus (HV) is a single-stranded, negative-sense RNA virus belonging to the genus Orthohantavirus, family Hantaviridae. It is a typical zoonotic virus, primarily transmitted from rodents (the natural reservoir hosts, mainly mice and rats) to humans. The main transmission routes include inhalation of aerosols contaminated by rodent excreta (feces, urine, saliva), direct contact with rodent excreta or the rodents themselves, and indirect contact with contaminated objects or food. In infected humans, HV can cause a spectrum of clinical manifestations, ranging from asymptomatic infection to acute febrile illness and severe hemorrhagic fever with renal syndrome (HFRS). Initial symptoms often mimic influenza, including high fever, severe headache, low back pain, orbital pain (known as “three pains”), fatigue, myalgia, and gastrointestinal symptoms such as nausea and vomiting. Severe cases progress to renal impairment, systemic hemorrhage, hypotensive shock, and even death. The case fatality rate varies by HV serotype, ranging from 5% to 40%, with some severe serotypes having a higher mortality rate. The incubation period is usually 7 to 14 days, but may extend to 45 days in rare cases. Currently, there is no specific antiviral treatment or widely available vaccine for hantavirus infection in humans or animals. The primary clinical management is supportive care.
Test Benefits:
- Easy-to-operate design
- Stable at room temperature
- Accurate and reliable results
Ordering Information
| Specimen | Specimen Type | Kit Size | Format | Storage |
|---|---|---|---|---|
| Hantavirus Fluorescence PCR Kit (Lyophilized) | Blood, Urine, Tissue | 48 Tests/Kit | Lyophilized | 2℃ to 30℃ |
| Hantavirus Detection Kit (Fluorescence PCR) | Blood, Urine, Tissue | 48 Tests/Kit | Liquid | -25℃ to -15℃ |
Test Procedure
Hepatitis B Virus Detection Kit (Fluorescence PCR)
This kit can be used for the quantitative detection of Hepatitis B virus DNA (genotypes A-H) in human plasma or serum. The results are only for clinical reference and should not be used as conclusive evidence for the diagnosis or exclusion of diseases.
Specifications
- Analytical Sensitivity (LoD): 20 IU/mL
- Storage: -20℃±5℃
- Shelf Life: 12 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0226EY | Hepatitis B Virus Detection Kit (Fluorescence PCR) | Plasma (EDTA anticoagulant) or serum | 48 Tests/Kit | / |
| 101A0226ED | 48 Tests/Kit (Lyophilization) |
Hepatitis C Virus Detection Kit (Fluorescence PCR)
This kit can be used for the quantitative detection of Hepatitis C virus RNA (genotypes 1-6) in human plasma or serum. The results are only for clinical reference and should not be used as conclusive evidence for the diagnosis or exclusion of diseases.
Specifications
- Analytical Sensitivity (LoD): 20 IU/mL
- Storage: -20℃±5℃
- Shelf Life: 12 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0225EY | Hepatitis C Virus Detection Kit (Fluorescence PCR) | Plasma (EDTA anticoagulant) or serum | 48 Tests/Kit | / |
| 101A0225ED | 48 Tests/Kit (Lyophilization) |
Herpes Simplex Virus I Detection Kit (Fluorescence PCR)
The Herpes Simplex Virus I Detection Kit (Fluorescence PCR) is a real-time PCR test suitable for the in vitro qualitative detection of Herpes Simplex Virus I (HSV1) DNA in specimens from individuals suspected of Herpes Simplex Virus I infectious.
Specification
- Analytical Sensitivity (LoD): 1000 copies/mL
Storage
- 101A0209EY: -20℃±5℃
- 101A0209ED (Lyophilization): 0℃-35℃
Shelf Life
- 101A0209EY: 12 months
- 101A0209ED (Lyophilization): 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0209EY | Herpes Simplex Virus I Detection Kit (Fluorescence PCR) | Oral vesicular lesions or cutaneous and mucocutaneous lesion swab | 48/96 Tests/Kit | CE Marked |
| 101A0209ED | 48/96 Tests/Kit (Lyophilization) |
Herpes Simplex Virus II Detection Kit (Fluorescence PCR)
The Herpes Simplex Virus II Detection Kit (Fluorescence PCR) is an in vitro real-time PCR test for the presumptive qualitative detection of the Herpes Simplex Virus II (HSV2) DNA in male urethral swab and female cervical secretions samples from individuals suspected of infection.
Specification
- Analytical Sensitivity (LoD): 1000 copies/mL
Storage
- 101A0216EY: -20℃±5℃
- 101A0216ED (Lyophilization): 0℃-35℃
Shelf Life
- 101A0216EY: 12 months
- 101A0216ED (Lyophilization): 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0216EY | Herpes Simplex Virus II Detection Kit (Fluorescence PCR) | Male urethral swab and female cervical secretions | 48/96 Tests/Kit | CE Marked |
| 101A0216ED | 48/96 Tests/Kit (Lyophilization) |
Human Immunodeficiency Virus I Detection Kit (Fluorescence PCR)
This kit can be used for the quantitative detection of Human lmmunodeficiency Virus (HIV) RNA (genotypes 1/2) in plasma or serum. The results are only for clinical reference and should not be used as conclusive evidence for the diagnosis or exclusion of diseases.
Specifications
- Analytical Sensitivity (LoD): 25 IU/mL
- Storage: -20℃±5℃
- Shelf Life: 12 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| AHIV101 | Human Immunodeficiency Virus Ⅰ Detection Kit (Fluorescence PCR) | Plasma (EDTA anticoagulant) or serum | 48 Tests/Kit | / |
| AHIV101D | 48 Tests/Kit (Lyophilization) |
Human Parainfluenza Virus Type I/III & Adenovirus Detection Kit (Fluorescence PCR)
The Human Parainfluenza Virus Type I/III & Adenovirus Detection Kit (Fluorescence PCR) is a real-time RT-PCR test for the simultaneous in vitro qualitative detection and differentiation of Human parainfluenza I virus, Human parainfluenza Ill virus, and/or Human adenovirus nucleic acid in oropharyngeal swab and nasopharyngeal swab specimens from individuals suspected of respiratory viral infection.
Specification
- Analytical Sensitivity (LoD): 500 copies/mL
Storage
- APA01: -20℃±5℃
- APA01D (Lyophilization): 0℃-35℃
Shelf Life
- APA01: 12 months
- APA01D (Lyophilization): 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| APA01 | Human Parainfluenza Virus Type I/III & Adenovirus Detection Kit (Fluorescence PCR) | Oropharyngeal swab or nasopharyngeal swab | 48/96 Tests/Kit | CE Marked |
| APA01D | 48/96 Tests/Kit (Lyophilization) |
Influenza A/B Virus Detection Kit (Fluorescence PCR)
The Influenza A/B Virus Detection Kit (Fluorescence PCR) is a qualitative in vitro real-time RT-PCR test for the detection of nucleic acid from influenza A virus or influenza B virus in specimens from individuals suspected of respiratory tract infectious diseases.
Specification
- Analytical Sensitivity (LoD): 1000 copies/mL
Storage
- 101A0201EY: -20℃±5℃
- 101A0201ED (Lyophilization): 0℃-35℃
Shelf Life
- 101A0201EY: 12 months
- 101A0201ED: 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0201EY | Influenza A/B Virus Detection Kit (Fluorescence PCR) | Oropharyngeal swab and nasopharyngeal swab | 48 Tests/Kit | CE Marked |
| 101A0201ED | 48 Tests/Kit (Lyophilization) |
Influenza A/B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR)
The Influenza A/B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) is a real-time RT-PCR test for the simultaneous in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and or respiratory syncytial virus nucleic acid in specimens from individuals suspected of respiratory viral infection.
Features
- Differential Analysis: Accurate differentiation of Respiratory syncytial virus, Influenza A and B viruses
- Multiplex Assay: 1 sample, 3 targets
Specification
- Analytical Sensitivity (LoD): 500 copies/mL
Storage
- AFR01: -20℃±5℃
- AFR01D (Lyophilization): 0℃-35℃
Shelf Life
- AFR01: 12 months
- AFR01D: 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| AFR01 | Influenza A/B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) | Oropharyngeal swab and nasopharyngeal swab | 48/96 Tests/Kit | CE Marked |
| AFR01D | 48/96 Tests/Kit (Lyophilization) |
Monkeypox Virus Detection Kit (Fluorescence PCR)
The Monkeypox Virus Detection Kit (Fluorescence PCR) is a qualitative in vitro real-time PCR test for the detection of nucleic acid from monkeypox virus in specimens from individuals suspected of monkeypox virus infectious.
Specifications
- Analytical Sensitivity (LoD): 200 copies/mL
Storage
- AMPV01: -20℃±5℃
- AMPV01D (Lyophilization): 0℃-35℃
Shelf Life
- AMPV01: 12 months
- AMPV01D (Lyophilization): 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| AMPV01 | Monkeypox Virus Detection Kit (Fluorescence PCR) | Oropharyngeal swab, nasopharyngeal swab, serum, plasma and human pustular or vesicular rash | 48/96 Tests/Kit | CE Marked |
| AMPV01D | 48/96 Tests/Kit (Lyophilization) |
Mycoplasma Pneumoniae Virus Detection Kit (Fluorescence PCR)
The Mycoplasma Pneumoniae Virus Detection Kit (Fluorescence PCR) is a qualitative in vitro real-time PCR test for the detection of nucleic acid from Mycoplasma Pneumoniae Virus in oropharyngeal swab or nasopharyngeal swab from individuals suspected of respiratory tract infectious diseases.
Specification
- Analytical Sensitivity (LoD): 1000 copies/mL
Storage
- 101A0207EY: -20℃±5℃
- 101A0207ED (Lyophilization): 0℃-35℃
Shelf Life
- 101A0207EY: 12 months
- 101A0207ED (Lyophilization): 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0207EY | Mycoplasma Pneumoniae Virus Detection Kit (Fluorescence PCR) | Oropharyngeal swab or nasopharyngeal swab | 48/96 Tests/Kit | CE Marked |
| 101A0207ED | 48/96 Tests/Kit (Lyophilization) |
SARS-CoV-2 Detection Kit (Fluorescence RT-PCR)
The SARS-CoV-2 Detection Kit (Direct Fluorescence PCR) is a rapid real-time RT-PCR test without RNA-purification intended for the presumptive qualitative detection of nucleic acid from the SARS-CoV-2 virus in oropharyngeal swab and nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider.
Features
- Extraction free preparation
- Exceptional Speed: Entire amplification protocol is about 65 minutes
- Reduced Handling: Less hands-on time and risk of contamination
Specifications
- Analytical Sensitivity (LoD): 200 copies/mL
- Storage: -20℃±5℃
- Shelf Life: 12 months
Ordering Information
| Product Description | Specimen | Catalog No. | Kit Size | Registration |
|---|---|---|---|---|
| SARS-CoV-2 Detection Kit (Direct Fluorescence PCR) | Oropharyngeal swab or Nasopharyngeal swab | ACOV01 | 48/96 Tests/Kit | CE Marked |
SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR)
The SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) is a rapid real-time RT-PCR test without RNA-purification intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus nucleic acid in oropharyngeal swab and nasopharyngeal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
Features
- Differential Analysis: Accurate differentiation of SARS-CoV-2, Influenza A and B viruses
- Multiplex Assay: 1 sample, 3 targets
- Extraction free preparation
Specifications
- Analytical Sensitivity (LoD): 1000 copies/mL
- Storage: -20℃±5℃
- Shelf Life: 12 months
Ordering Information
| Product Description | Specimen | Catalog No. | Kit Size | Registration |
|---|---|---|---|---|
| SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) | Oropharyngeal swab, nasopharyngeal swab | ACAB01 | 48/96 Tests/Kit | CE Marked |
Mycobacterium Tuberculosis Complex Detection Kit (Fluorescence PCR)
The Mycobacterium Tuberculosis Complex Detection Kit is a qualitative in vitro test for the detection of Mycobacterium tuberculosis complex (MTBC) DNA in sputum specimens.
Specification
- Analytical Sensitivity (LoD): 100 bacteria/mL
Storage
- 101A0205EY: -20℃±5℃
- 101A0205ED (Lyophilization): 0℃-35℃
Shelf Life
- 101A0205EY：12 months
- 101A0205ED (Lyophilization): 18 months
Ordering Information
| Catalog No. | Specimen | Product Description | Kit Size | Registration |
|---|---|---|---|---|
| 101A0205EY | Mycobacterium Tuberculosis Complex Detection Kit (Fluorescence PCR) | Sputum | 48/96 Tests/Kit | CE Marked |
| 101A0205ED | 48/96 Tests/Kit (Lyophilization) |