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Clongen Laboratories, LLC.

Gaithersburg, Maryland, US

We operate in accordance with FDA guidelines and offer a long list of studies required for lot release and FDA review under GLP conditions (We are FDA-Registered). What sets us apart from our competition is our responsiveness to our clients concerns and questions, the high quality service and reporting, competitive pricing and our state of the art laboratory. We try our best to provide as much information as we can in order to assist our clients in making informed decisions with the choice of studies and technical protocol details. Please select the service you would like to explore from the quick links menu below.

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Sterility Testing
Price on request

Sterility Testing – Bacteriostasis – Fungistasis – Bioburden Testing

Sterility Testing – Membrane Filtration (GLP)
Sterility Testing – Membrane Filtration (Non-GLP)
Sterility Testing – Direct Inoculation (GLP)
Sterility Testing – Direct Inoculation (Non-GLP)
Bioburden Testing (GLP)
Bacteriostasis/Fungistasis (GLP)

Sterility Testing – Bacteriostasis – Fungistasis – Bioburden Testing

Sterility Testing – Membrane Filtration (GLP)
Sterility Testing – Membrane Filtration (Non-GLP)
Sterility Testing – Direct Inoculation (GLP)
Sterility Testing – Direct Inoculation (Non-GLP)
Bioburden Testing (GLP)
Bacteriostasis/Fungistasis (GLP)

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Mycoplasma Elimination
Price on request

Clongen Laboratories offer Mycoplasma Elimination service that will clean up a cell line using a commercially available antibiotic cocktail. With this service, you will receive one PCR test at baseline for Mycoplasma presence, two PCR tests during the course of the treatment and one test five days after stopping the treatment to... Show more »

Clongen Laboratories offer Mycoplasma Elimination service that will clean up a cell line using a commercially available antibiotic cocktail. With this service, you will receive one PCR test at baseline for Mycoplasma presence, two PCR tests during the course of the treatment and one test five days after stopping the treatment to screen for the presence of Mycoplasma. You will receive a detailed 5-7 page report describing all work done with gel images and a certificate of quality along with a working cell bank of 25 vials at a minimum of 1 million cells per vial on dry ice.

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Cell-Based Assays
Price on request

Endotoxin Test (Limulus Amoebocyte Lysate - LAL) - cGMP - Kinetic Assay
Endotoxin Test (Limulus Amoebocyte Lysate - LAL) - GLP - Kinetic Assay
In vitro Testing for Adventitious Viruses in Three Cell Lines
In vivo Testing for Adventitious Viruses in Embryonated Hen Eggs
Isoenzyme Electrophoresis for Determination of Cell Line... Show more »

Endotoxin Test (Limulus Amoebocyte Lysate - LAL) - cGMP - Kinetic Assay
Endotoxin Test (Limulus Amoebocyte Lysate - LAL) - GLP - Kinetic Assay
In vitro Testing for Adventitious Viruses in Three Cell Lines
In vivo Testing for Adventitious Viruses in Embryonated Hen Eggs
Isoenzyme Electrophoresis for Determination of Cell Line Origin
Mycoplasma Elimination from Contaminated Cell Lines
Mycoplasma Screen by Hoechst Staining (GLP)
Mycoplasma Screen by Hoechst Staining (Non-GLP)
Mycoplasma Testing by Direct Cultivation on enriched Mycoplasma Media-GLP
Residual Bovine Serum Albumin (BSA) Concentration by ELISA
Residual Human Serum Albumin (HSA) Concentration by ELISA
Sterility Testing - Direct Inoculation (GLP)
Sterility Testing - Direct Inoculation (Non-GLP)
Sterility Testing - Membrane Filtration (GLP)
Sterility Testing - Membrane Filtration (Non-GLP)
Virus Titration

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Mycoplasma Testing
Price on request

We offer Mycoplasma testing in cell lines, biologicals and samples of human origin by PCR, cell-based fluorescence, according to 21CFR 610.30, 9CFR113.28 or the 1993 Points to Consider Guidelines.

We offer Mycoplasma testing in cell lines, biologicals and samples of human origin by PCR, cell-based fluorescence, according to 21CFR 610.30, 9CFR113.28 or the 1993 Points to Consider Guidelines.

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Sexually Transmitted Disease Testing
Price on request

Specificity analysis for test to identify chlamydia and gonorrhea in urine samples by qPCR.


Turn-around time: 1-3 days


How do I ship my samples to Clongen Labs for testing?
• Urethral or Cervical swabs as well as urine samples are accepted for chlamydia and gonorrhea... Show more »

Specificity analysis for test to identify chlamydia and gonorrhea in urine samples by qPCR.


Turn-around time: 1-3 days


How do I ship my samples to Clongen Labs for testing?
• Urethral or Cervical swabs as well as urine samples are accepted for chlamydia and gonorrhea testing. • Samples must be sent overnight on blue ice (ice packs).
• Samples should be shipped Monday through Thursday. We do not accept samples on Saturday and Sunday unless it is local.


Candida albicans
Candida galbrata
Candida parapsilosis
Candida species
Candida tropicalis
Chlamydia pneumoniae
Chlamydia trachomatis
Chlamydia-Gonorrhea Panel
Epstein Barr Virus (EBV)
Gardnerella vaginalis
Hepatitis B Virus
Hepatitis C Virus
Herpes Simplex Virus 1 & 2 (HSV 1&2)
Herpes Simplex Virus 1 (HSV-1)
Herpes Simplex Virus 2 (HSV-2)
Human Cytomegalovirus (HCMV)
Human Herpes Virus 6 (HHV-6)
Human Herpes Virus 8 (HHV-8)
Human Immunodeficiency Virus 1 (RT-PCR Testing is available for Research only)
Human Papilloma Virus (HPV)
Human T-Cell Leukemia Viruses I & II - RT PCR
Lyme Disease (Borrelia burgdorferi) - PCR - Human Whole Blood (EDTA tube required)
Lyme Disease (Borrelia burgdorferi) - Western Blot
Mycobacterium tuberculosis
Mycoplasma genitalium
Mycoplasma hominis
Mycoplasma penetrans
Mycoplasma pneumoniae
Mycoplasma species
Neisseria gonorrhoeae (Gonorrhea Agent)
Pan - Fungal Detection - Detection of the presence of any fungus by PCR
Pneumocystis jiroveci (P. carinii)
Staphylococcus aureus
Trichomonas vaginalis (PCR)
Ureaplasma urealyticum
Trichomonas vaginalis

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Pathogen Detection Assay Panels
Price on request

Bloodborne Pathogen Tests

Epstein Barr Virus (EBV)
Hepatitis A Virus
Hepatitis B Virus
Hepatitis C Virus
Human Cytomegalovirus (HCMV)
Human Herpes Virus 6 (HHV-6)
Human Herpes Virus 8 (HHV-8)
Human Immunodeficiency Virus 1&II (RT-PCR Testing is available for Research only)
West Nile Virus

Bloodborne Pathogen Tests

Epstein Barr Virus (EBV)
Hepatitis A Virus
Hepatitis B Virus
Hepatitis C Virus
Human Cytomegalovirus (HCMV)
Human Herpes Virus 6 (HHV-6)
Human Herpes Virus 8 (HHV-8)
Human Immunodeficiency Virus 1&II (RT-PCR Testing is available for Research only)
West Nile Virus

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Microbiology Testing
Price on request

Sample types:

  • Blood Culture
  • Gastrointestinal tract
  • Respiratory tract
  • Eye, Ear, Nose and Sinuses
  • Urine tract
  • Genital tract
  • Wounds and Abscesses
  • Semen and Breast culture
  • Stool samples for culture, Ova and Parasites
  • Mycology Testing for the presence of Mold or Yeast and Identification

Sample types:

  • Blood Culture
  • Gastrointestinal tract
  • Respiratory tract
  • Eye, Ear, Nose and Sinuses
  • Urine tract
  • Genital tract
  • Wounds and Abscesses
  • Semen and Breast culture
  • Stool samples for culture, Ova and Parasites
  • Mycology Testing for the presence of Mold or Yeast and Identification
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Virology Testing
Price on request

Adenovirus
Andes Virus and Sin Nombre Virus
Chikungunya Virus
Colorado Tick Fever Virus (CTFV)
Coxsackie Virus A & B
Ebola Virus – Cote d’Ivoire
Dengue Viruses
Ebola Virus – Sudan Strain
Ebola Virus – Zaire Strain
Epstein Barr Virus (EBV)
Hantaan Virus
Heartland Virus
Hepatitis A Virus
Hepatitis A, B & C... Show more »

Adenovirus
Andes Virus and Sin Nombre Virus
Chikungunya Virus
Colorado Tick Fever Virus (CTFV)
Coxsackie Virus A & B
Ebola Virus – Cote d’Ivoire
Dengue Viruses
Ebola Virus – Sudan Strain
Ebola Virus – Zaire Strain
Epstein Barr Virus (EBV)
Hantaan Virus
Heartland Virus
Hepatitis A Virus
Hepatitis A, B & C Panel
Hepatitis B Virus
Hepatitis C Virus
Herpes Simplex Virus 1 & 2 (HSV 1&2)
Herpes simplex virus 2 (HSV-2)
HPV-16
HPV-18
Human Bocavirus
Human Coronavirus 229E
Human Coronavirus OC43
Human Cytomegalovirus (HCMV)
Human Herpes Virus 6 (HHV-6)
Human Herpes Virus 7 (HHV-7)
Human Herpes Virus 8 (HHV-8)
Human Immunodeficiency viruses I & II
Human Metapneumovirus
Human Papilloma Virus (HPV)
Human Rotavirus A
Human T-Cell Leukemia Viruses I & II - RT PCR
Influenza Virus A
Influenza Virus B
Molluscum contagiosum virus (MCV)
Norwalk Virus (Norovirus)
Parainfluenza virus 1
Parainfluenza virus 2
Parainfluenza virus 3
Parainfluenza virus 4
Powassan Virus
Respiratory Syncytial virus A
Respiratory Syncytial virus B
Rhino Virus
Rift Valley Fever Virus
Severe Acute Respiratory Syndrome (SARS)
Varicella Zoster
West Nile Virus
Herpes simplex virus 1 (HSV-1)
Zika Virus Molecular Detection

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qPCR
Quantitative PCR
Price on request
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Western Blot
Price on request

Clongen Laboratories offers the Western blot immunoassay for Lyme Disease. Specifically, the Western blot detects a patient’s antibodies to a variety of Borrelia burgdorferi proteins. Unlike many other labs that use the human eye to judge the darkness of patients’ bands, Clongen uses a highly accurate optical scanner to... Show more »

Clongen Laboratories offers the Western blot immunoassay for Lyme Disease. Specifically, the Western blot detects a patient’s antibodies to a variety of Borrelia burgdorferi proteins. Unlike many other labs that use the human eye to judge the darkness of patients’ bands, Clongen uses a highly accurate optical scanner to calculate the intensity of the bands. The final report for the patient will include a table of bands with the standard +1, +2, +3, and +4 ratings. Also, the report contains an additional printout with both the patient and positive control strip images, and a table with the quantitative optical intensity values of each band present. Although Clongen Laboratories uses CDC standards for grading Western blots, the in-depth report allows physicians to interpret the results for themselves and make the final diagnosis.

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Chronic Fatigue Syndrome (CFS) Infectious Disease Gene Panel
Price on request

Epstein Barr Virus (EBV)
Hepatitis B Virus
Hepatitis C Virus
Human Cytomegalovirus (HCMV)
Human Herpes Virus 6 (HHV-6)
Human Herpes Virus 8 (HHV-8)
Human Immunodeficiency Virus 1 (RT-PCR Testing is available for Research only)
Human T-Cell Leukemia Viruses I & II - RT PCR
Lyme Disease (Borrelia burgdorferi) - PCR -... Show more »

Epstein Barr Virus (EBV)
Hepatitis B Virus
Hepatitis C Virus
Human Cytomegalovirus (HCMV)
Human Herpes Virus 6 (HHV-6)
Human Herpes Virus 8 (HHV-8)
Human Immunodeficiency Virus 1 (RT-PCR Testing is available for Research only)
Human T-Cell Leukemia Viruses I & II - RT PCR
Lyme Disease (Borrelia burgdorferi) - PCR - Human Whole Blood (EDTA tube required)
Lyme Disease (Borrelia burgdorferi) - Western Blot
Mycobacterium tuberculosis
Mycoplasma genitalium
Mycoplasma hominis
Mycoplasma penetrans
Mycoplasma pneumoniae
Mycoplasma species
Plasmodium falciparum
West Nile Virus
Acinetobacter baumannii
Schistosoma mansoni

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Respiratory Infection Gene Panel
Price on request

*Pulmonary Disease Tests"

Chlamydia pneumoniae
Chlamydia trachomatis
Corona Virus
Five virus panel - ADV, CV, Inf. Rhino, RSV
Fungi
Influenza Virus
Legionella pneumophila
Mycobacterium tuberculosis
Mycoplasma hominis
Mycoplasma penetrans
Mycoplasma pneumoniae
Mycoplasma species
Pneumocystis jiroveci (P.... Show more »

*Pulmonary Disease Tests"

Chlamydia pneumoniae
Chlamydia trachomatis
Corona Virus
Five virus panel - ADV, CV, Inf. Rhino, RSV
Fungi
Influenza Virus
Legionella pneumophila
Mycobacterium tuberculosis
Mycoplasma hominis
Mycoplasma penetrans
Mycoplasma pneumoniae
Mycoplasma species
Pneumocystis jiroveci (P. carinii)
Rhino Virus
Seven virus panel - ADV, Inf-A, Inf-B, Para-1, Para-2, Para-3 & RSV

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Clinical Research
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Clinical Laboratory Services
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Clinical Chemistry
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Clinical Molecular Diagnostics
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Gene Panel Testing
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Clinical Microbiology, Virology and Parasitology
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Biology
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Cells and Tissues
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Testing of Cell Lines
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Biochemistry & Molecular Biology
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Protein Services
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Protein Expression Visualization
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Nucleic Acid Services
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DNA Services
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PCR
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Product Development, Testing, and Packaging
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Product Quality Control
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Product Testing Services
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