https://www.fda.gov/media/136231/download

"Intended Use
The Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR (“Quest SARS-CoV-2 rRT-PCR”) is a real-time
RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory
specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, tracheal aspirates, and bronchoalveolar lavage)
collected from individuals suspected of COVID-19 by their healthcare provider.

This test is also for use with nasal swab specimens that are self-collected at home or in a healthcare setting by individuals
using an authorized home-collection kit when determined to be appropriate by a healthcare provider.

This test is for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples containing up to four of
the individual upper respiratory swab specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs)
that were collected in individual vials containing transport media from individuals suspected of COVID-19 by their
healthcare provider. Negative results from pooled testing should not be treated as definitive. If patient’s clinical signs and symptoms are inconsistent with a negative result or results are necessary for patient management, then the patient should
be considered for individual testing. Specimens included in pools with a positive, inconclusive, or invalid result must be
tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to
the decreased sensitivity of pooled testing.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory
specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical
correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause" of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Überall steht klar, dass nur RNA detektiert wird, und zwar nicht quantitativ, sondern nur qualitativ. Der Test weist keine Infektion nach, um diese festzustellen, müssen weitere klinische Informationen hinzugenommen werden. Ein positiver Test ist lediglich ein Anzeichen, dass SARS-COV-2 RNA vorliegt.

Bei den Tests, die bei uns in Massen gemacht werden und Patienten in Quarantäne schicken, werden keine weiteren klinischen Informationen ausgewertet.