SARS-CoV-2 Nucleic Acid Detection Kit (RT-PCR)
【Test Principle】
This kit based on real-time PCR fluorescence technology, and the
specific primers and corresponding fluorescent probes target to the
conserved region of COVID-19 genome was designed for highly
specific detection. By detecting the fluorescent signals changes,
the COVID-19 nucleic acid from a throat swab or nasopharyngeal
secretion specimen can be qualitatively detected.
【Sample Requirement】
1. Applicable sample type: Throat swab (Oropharyngeal swab/Nasal
swab)
2. Sample collection
2.1 Sample time: The reagent is not affected by the specific
clinical symptoms of patients, and
can be sampled at each stage of the course of the disease.
2.2 The test performance of the reagent is not affected when using
the drugs described in the
analysis performance evaluation, and the sample can be taken
normally. It is better to take
samples before using other unverified drugs
2.3 Throat swab requirement: It’s better to use long handle swab
with polypropylene fiber head
or wood handle swab, please select the preservation solution
suitable for cells and viruses.
It is better to directly select the commercial throat swab sampling
tube.
3. Sampling method:
3.1 Oropharyngeal swab: Wipe both tonsils and the posterior
pharyngeal wall with a swab with
moderate force to avoid touching the tongue.
3.2 Nasal swab: Use the swab to penetrate the nasal cavity for 2-3
cm, and rotate it for 2-3 times.
【Storage conditions and the period of Validity】
This kit shall be stored at the temperature below -20℃ in dark and
avoid repeated freezing and
thawing (if freezing and thawing, must not exceed 4 times), with a
validity period of 12 months. It
can be stored at -20℃ after opening the cover, with a validity
period of 30 days. The kit shall be
transported in an ice box filled with 50% of the total volume of
dry ice for no more than 5 days.
【Result judgment】
1. Determine the validity of the experiment:
The positive control FAM, VIC channel should have a typical amplification curve, and
the Ct value is generally less than 36, but may
fluctuate due to different threshold settings of different
instruments.
The negative control FAM, VIC channel should be non-amplified Ct. It is agreed that the
above requirements must be met at the same time, otherwise this
test is invalid.
2. Result judgment
FAM/VIC channel
Judgment result
Ct＜37
Sample test is positive
37≤Ct＜40
The amplification curve is S-shaped, and suspicious samples
need to be re-examined; if the re-examination results are
consistent, it is judged as positive, otherwise it is negative.
Ct≥40 Or No Amplification
Sample test is negative (or below the lower limit of kit detection)
