QIAGEN QuantiFERON Instruction Manual

Sample to Insight__

626410

www.qiagen.com

QIAGEN

R1

1122892

®

QuantiFERON

ELISA
Instructions for Use
(Handbook)

Human IFN-γ ELISA test

November 2020

2 x 96

For Research Use Only
Not for use in diagnostic procedures

, 19300 Germantown Road, Germantown, MD 20874, USA

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QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

3

Contents

Intended Use .............................................................................................................. 5

Principle of the Procedure ............................................................................................ 6

Time required to perform the assay ..................................................................... 6

Materials Provided ...................................................................................................... 7

Kit contents ...................................................................................................... 7

Materials required but not provided .............................................................................. 8

Warnings and Precautions ........................................................................................... 9

Safety information ............................................................................................ 9

Precautions ...................................................................................................... 9

Storage and Handling ............................................................................................... 12

ELISA kit reagents ........................................................................................... 12

Reconstituted and unused ELISA reagents .......................................................... 12

Procedure ................................................................................................................ 13

Interpretation of Results .............................................................................................. 18

Generation of standard curve .......................................................................... 18

Quality control of test ...................................................................................... 19

Analytical performance ................................................................................... 20

Technical Information ................................................................................................ 22

Clotted plasma samples .................................................................................. 22

Troubleshooting Guide .............................................................................................. 23

Symbols ................................................................................................................... 25

Contact Information .................................................................................................. 26

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QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

Appendix A – Abbreviated Test Procedure ................................................................... 27

Ordering Information ................................................................................................ 29

Document Revision History ......................................................................................... 30

QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

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Intended Use

The QuantiFERON ELISA (QFN) is for research use only to detect human interferon gamma
(IFN-γ) in plasma by enzyme-linked immunosorbent assay (ELISA).

The QuantiFERON ELISA can be used to detect IFN-γ in plasma generated from QuantiFERON
Blood Collection Tubes.

The QFN ELISA is not for use in diagnostic procedures.

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QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

Principle of the Procedure

The concentration of IFN-γ in a human plasma sample reported in International Units per ml
(IU/ml) is measured by QuantiFERON ELISA.

Time required to perform the assay

The time required to perform the QFN ELISA is estimated below. The time of testing multiple
samples when batched is also indicated.

 ELISA Approx. 3 hours for one ELISA plate

(up to 88 samples)
<1 hour labor
Add 10–15 minutes for each extra plate

QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

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Catalog no.

Materials Provided

Kit contents

QuantiFERON® 2 Plate Kit ELISA

Microplate Strips,12 x 8 wells

IFN-γ Standard, lyophilized

Green Diluent

Conjugate 100x Concentrate, lyophilized

Wash Buffer 20x Concentrate 1 x 100 ml

Enzyme Substrate Solution 1 x 30 ml

Enzyme Stopping Solution* 1 x 15 ml

Language Sheet 1

2 Plate kit ELISA

626410

2 sets
12 x 8-well Microplate
Strips

1 x vial
(8 IU/ml when
reconstituted)

1 x 30 ml vial

1 x 0.3 ml, when
reconstituted

* Contains sulfuric acid. See Warnings and Precautions.

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QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

Materials required but not provided

 Calibrated variable-volume pipets*
 Calibrated multichannel pipet* capable of delivering 50 µl and 100 µl with disposable

tips

 Microplate shaker†
 Deionized or distilled water, 2 liters
 Microplate washer (automated washer recommended)
 Microplate reader† fitted with 450 nm filter and 620 nm to 650 nm reference filter
 Graduated cylinder (measuring cylinder)
 Low-lint absorbent towels
 Plate lid

* Ensure that the instruments have been checked and calibrated according to the manufacturer’s recommendations.

QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

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Handle human plasma as if potentially infectious.

products in accordance with federal, state, and local

Warnings and Precautions

Safety information

For Research Use Only. Not for use in diagnostic procedures.

When working with chemicals, always wear a suitable lab coat, disposable gloves, and
protective goggles. For more information, please consult the appropriate safety data sheets
(SDSs). These are available online in convenient and compact PDF format at
www.qiagen.com/safety where you can find, view, and print the SDS for each QIAGEN kit
and kit component.

Precautions

CAUTION

Observe relevant blood and blood product handling guidelines.
Dispose of samples and materials in contact with blood or blood

regulations.

(C1)

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QuantiFERON ELISA Instructions for Use (Handbook) 11/2020

QuantiFERON Enzyme Stopping Solution

Contains: sulfuric acid. Warning! May be corrosive to metals.

QuantiFERON Enzyme Substrate Solution

Warning! Causes mild skin irritation. Wear protective

Contains: tartrazine. Warning! May cause an allergic skin

QuantiFERON Wash Buffer 20x Concentrate

Harmful to aquatic life with long lasting effects. Avoid release

Hazard statements

The following hazards and precautionary statements apply to components of the

QuantiFERON ELISA.

Causes skin irritation. Causes serious eye irritation. Wear
protective gloves/ protective clothing/ eye protection/ face
protection.

gloves/ protective clothing/ eye protection/ face protection.

QuantiFERON Green Diluent

reaction. Wear protective gloves/ protective clothing/ eye
protection/ face protection.

to the environment.