MMQCI
MMQCI

WE HAVE MOVED!

Subscribe to MMQCI E-Announcements
Email:

logo-rule
    INTROL™ ME Control Panel M262:
 
Product Name

INTENDED USE:

The INTROL ME Control Panel M262 is intended for in vitro use as a quality control to monitor the amplification and detection of multiple cerebrospinal fluid pathogens. Detection of the bacteria, viruses, and yeast listed in Table 1 are an important aid to the diagnosis of meningitis and encephalitis. Meningitis (infection of meninges surrounding the brain and spinal cord) and encephalitis (infection of the brain) may be fatal depending on the infectious agent. Clinical symptoms caused by a wide variety of pathogens are often indistinguishable.1 Therefore rapid laboratory diagnosis is critical to start and guide treatment.

INTROL ME Control Panel M262 is a Class I exempt, unassayed in vitro diagnostic control for qualitative molecular assays.

INTROL ME Control Panel M262 cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

PRODUCT SUMMARY and PRINCIPLE:

INTROL ME Control Panel M262 is composed of 2 controls, INTROL ME Positive M263 and INTROL ME Negative M264. INTROL ME Positive M263 contains synthetic RNA corresponding to genome segments of pathogens listed in Table 1. INTROL ME Negative M264 contains non-target RNA.

Best practice is to establish a quality control program for every assay performed by the laboratory.2,3 Routine use of quality controls that are consistent lot to lot assists the laboratory in identifying shifts, trends, and increased frequency of random errors caused by variations in the test system, such as failing reagents. Early investigation can prevent failed assay runs.

COMPOSITION:

The INTROL ME Control Panel M262 is comprised of 12 tubes, 200µL each, of synthetic RNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. INTROL ME Positive M263 contains nucleic acid segments of the bacteria, viruses, and yeast listed in Table 1.

STORAGE and STABILITY:

INTROL ME Control Panel M262 should be stored frozen (–20°C or colder).  Unopened INTROL ME Control Panel M262 is stable through the expiration date printed on the kit label when continuously stored frozen. INTROL ME Positive M263 and INTROL ME Negative M264 are for single use. Discard after use according to your local and federal regulations.

INSTRUCTIONS FOR USE:

  1. Allow the control to be tested to come to room temperature (18° – 25°C).
  2. Use the control as provided.  DO NOT DILUTE.
  3. Immediately before use, mix the control by briefly vortexing the tube for 3 – 5 seconds and then shake the tube down firmly to remove any droplets caught in the cap.
  4. Analyze the control per the manufacturer instructions for use as a clinical sample.
  5. Discard after use according to your local and federal   regulations.

PRECAUTIONS and WARNINGS:

  • Do not dilute.
  • This product does not contain any biological material and is not infectious. Universal Precautions are NOT required when handling this product.

Table 1:

INTROL ME Positive M263

Bacteria

Escherichia coli K1

Haemophilus influenzae

Listeria monocytogenes

Neisseria meningitidis

Streptococcus agalactiae

Streptococcus pneumoniae

Viruses

Cytomegalovirus

Enterovirus

Herpes simplex virus 1

Herpes simplex virus 2

Human herpesvirus 6

Human parechovirus

Varicella zoster virus

Yeast

Cryptococcus neoformans/ gattii

EXPECTED VALUES:

The laboratory should follow Good Laboratory Practice (GLP) and establish its own performance characteristics for INTROL ME Control Panel M262 in demonstrating adequate system performance. Recoveries may vary depending on instrumentation, reagents and systematic or random errors.

ORDERING INFORMATION:

INTROL ME Control Panel M262

Part Number: M262

Kit Contains:

12 tubes x 200 µL

6 each of M26318 & M26418

 

Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco, Maine 04072 USA

Phone: 207-885-1072, FAX: 207-885-1079

Web:  www.mmqci.com, Email: info@mmqci.com

 

1. Tunkel AR; Hartman BJ; Kaplan SL; et al. (November 2004). "Practice guidelines for the management of bacterial meningitis" (PDF). Clinical Infectious Diseases 39 (9): 1267–84. doi:10.1086/425368. PMID 15494903.

2. ISO 15189: Medical laboratories – Particular requirements for quality and competence.

3. CAP Molecular Pathology Checklist; Commission on Laboratory Accreditation, Laboratory Accreditation Program, Mol.20000

Safety Data Sheet

 


Maine Molecular Quality Controls Inc. | Telephone: 207.885.1072 | Fax: 207.885.1079 | Email
| 17 years of quality commitment

© 2017 Maine Molecular Quality Controls, INC.