Malaria P. falciparum Culture Panel Product Code: KZMC046

Malaria P. falciparum Culture Panel
Product Code: KZMC046
Strain: Borneo (Type C)
Lot Number: 1611-272-00026
For Research Use Only. Not for use in diagnostic procedures.
NAME AND INTENDED USE:
The Malaria P. falciparum Culture Panel is intended for use with in vitro tests
for the determination of the presence or absence of P. falciparum based on
the detection of the histidine rich protein 2 (HRP2) or assays for the
quantification of HRP2. This panel is for Research Use Only and should not
be used in diagnostic procedures.
SUMMARY:
The Malaria P. falciparum Culture Panel can be used to evaluate the analytical
performance of HRP2 detecting assays. Each panel contains aliquots of a P.
falciparum laboratory strain at seven predetermined HRP2 concentrations as
well as negative aliquots. This panel can be used to evaluate the performance
of assay or diagnostic test based on the detection or quantification of HRP2.
PRINCIPLES OF THE PROCEDURE:
The Malaria P. falciparum Culture Panel has been designed for use with in
vitro test for detecting the presence or absence of P. falciparum through the
detection of HRP2 and with laboratory assay for the quantification of HRP2.
The Malaria P. falciparum Culture Panel is prepared from human and nonhuman components. The Malaria P. falciparum Culture Panel reagents should
be evaluated as unknown specimens per the instructions supplied by the
manufacturer of the in vitro assay being used.
REAGENTS:
The Malaria P. falciparum Culture Panel reagents contain culture-derived P.
falciparum parasites diluted in human whole blood at decreasing HRP2
concentrations as follows:
1.
2.
3.
4.
5.
6.
7.
8.
Two vials 8,000 pg/mL (200 µL per vial).
Two vials 800 pg/mL (200 µL per vial). .
Two vials 400 pg/mL (200 µL per vial).
Two vials 120 pg/mL (200 µL per vial).
Two vials 40 pg/mL (200 µL per vial).
Two vials 12 pg/mL (200 µL per vial).
Two vials 4 pg/mL (200 µL per vial).
Two vials Negative (200 µL per vial).
SAFETY PRECAUTIONS:
1. Clean any spillage immediately and thoroughly using a suitable disinfectant
such as 1% bleach solution.
2. Handle and dispose of all specimens, controls and materials used in testing
as though they contain infectious agents (1-3).
HANDLING PRECAUTIONS:
1. Do not use Malaria P. falciparum Culture Panel reagents beyond the
expiration date.
2. Avoid contamination of reagents when opening and dispensing.
STORAGE INSTRUCTIONS:
1. Store Malaria P. falciparum Culture Panel reagents long term (≥30 days) at
≤ -70°C or Short Term (≤30 days) at ≤ -10°C when not in use.
2. Vials should be stored upright to prevent leakage.
3. For single use only.
INDICATIONS OF REAGENT INSTABILITY OR DETERIORATION:
1. Alterations in physical appearance may indicate instability or deterioration of
Malaria P. falciparum Culture Panel.
PROCEDURE:
1. The Malaria P. falciparum Culture Panel reagents may be included in a test
run following the procedure provided by the in vitro assay manufacturer for
unknown specimens.
2. Allow The Malaria P. falciparum Culture Panel reagents to thaw on ice prior
to use.
3. Mix contents by gentle swirling prior to use. Do not mix by vigorous shaking.
4. Vial should be considered for single use only. The HRP2 concentration of
vials undergoing several freeze-thaw cycles cannot be ensured.
INTERPRETATION OF RESULTS:
The Malaria P. falciparum Culture Panel test results should be determined as
recommended for unknown specimens in the package insert for each
commercially available test kit and compared to the reagent predetermined
HRP2 concentration.
WARNINGS AND PRECAUTIONS:
1. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC
PROCEDURES.
2. USE UNIVERSAL PRECAUTIONS: HANDLE AS IF CAPABLE OF
TRANSMITTING INFECTIOUS AGENTS.
The Malaria P. falciparum Culture Panel reagents are prepared from P.
falciparum laboratory culture samples and human whole blood. All materials
used in the preparation of The Malaria P. falciparum Culture Panel reagents
are known to be non-reactive for HIV1/2 Ab, HBsAg and HCV Ab. However,
no known test method can assure that products derived from human sources
will not transmit infection. It is recommended that these reagents and all
human specimens be handled in accordance with Biosafety Level 2 practices
as described in the CDC NIH publication, Biosafety in Microbiological and
Biomedical Laboratories (1), or other equivalent guidelines (2,3).
LIMITATION OF THE PROCEDURE:
1. Malaria P. falciparum Culture Panel reagents must not be substituted for
the positive and negative control reagents provided with some commercially
available test kits.
2. Malaria P. falciparum Culture Panel reagents are provided for Research
Use Only and should not be used in diagnostic procedures, for calibration
or as primary reference preparations for any test kit.
3. PROCEDURE and INTERPRETATION OF RESULTS provided in package
insert of each commercially available test kit must be followed closely when
testing the Malaria P. falciparum Culture Panel reagents. Deviations from
the recommended procedures may produce unreliable results.
4. It is the responsibility of each laboratory to determine the suitability of
Malaria P. falciparum Culture Panel reagents for its particular use. They
also must establish guidelines for the interpretation of results.
SPECIFIC PERFORMANCE CHARACTERISTICS:
The Malaria P. falciparum Culture Panel reagents were tested using
commercially available test systems following the procedures provided by the
manufacturer for the testing of unknown specimens. The data contained in the
Panel Box Key Code is intended to be for informational use only. Each
laboratory should establish its own performance characteristic.
This Product was manufactured in a facility which has a Quality Management System that is ISO 13485 certified.
ZeptoMetrix Corporation • 25 Kenwood Circle, Franklin, MA 02038 • Tel (508) 553-5800 • Fax (508) 520-1525
For Customer Support, please visit www.zeptometrix.com or email custserv@zeptometrix.com
Document Number: PIKZMC046 Rev01
Effective Date: 12/28/2016
Page 1 of 2
Malaria P. falciparum Culture Panel
Product Code: KZMC046
Strain: Borneo (Type C)
Lot Number: 1611-272-00026
For Research Use Only. Not for use in diagnostic procedures.
Product Key Code
Expiration Date: 01/06/2021
Variable
Values
Description
Comment
STUDY ID
01
Malaria specimen repository
Constant
CULUTRE PRODUCTION SITE
06
Supplier
N/A
STRAIN AND [HRP2]
0037
Borneo, 8000 pg/mL
Type A
0043
Borneo, 800 pg/mL
Type A
0054
Borneo, 400 pg/mL
Type A
0055
Borneo, 120 pg/mL
Type A
0056
Borneo, 40 pg/mL
Type A
0057
Borneo, 12 pg/mL
Type A
0058
Borneo, 4 pg/mL
Type A
0031,0059
Negative, n/a pg/mL
N/A
TYPE OF SPECIMEN
2
Culture specimen
Constant
ALIQUOT ID
001-999
Unique identification for each aliquot
This data is intended to be for informational purposes only.
They are not intended to represent performance specifications
REFERENCES:
1. U.S. Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS Publication (NIH) 93-8395. Washington: U.S. Government
Printing Office, May, 1993.
2. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Infectious Disease Transmitted by Blood, Body Fluids and Tissue – Second
Edition, Tentative Guideline. NCCLS Document M29-T2. Villanova, PA: NCCLS, 1991.
3. National Committee for Clinical Laboratory Standards. Clinical Laboratory Waste management; Approved Guideline> NCCLS Document GP 5-A. Villanova, PA: NCCLS, 1993.
This Product was manufactured in a facility which has a Quality Management System that is ISO 13485 certified.
ZeptoMetrix Corporation • 25 Kenwood Circle, Franklin, MA 02038 • Tel (508) 553-5800 • Fax (508) 520-1525
For Customer Support, please visit www.zeptometrix.com or email custserv@zeptometrix.com
Document Number: PIKZMC046 Rev01
Effective Date: 12/28/2016
Page 2 of 2